Title

Evaluation of the Pharmacokinetics and Safety of BAY3427080 (NT-814) in Post-Menopausal Women With Vasomotor Symptoms
Evaluation of the Pharmacokinetics and Safety of NT-814 in Post-Menopausal Women With Vasomotor Symptoms
  • Phase

    Phase 1/Phase 2
  • Study Type

    Interventional
  • Intervention/Treatment

    nt-814 ...
  • Study Participants

    76
This is a multi-center, double-blind, randomized, placebo-controlled multiple ascending dose study in post-menopausal women with vasomotor symptoms. Single ascending doses of NT-814 will be investigated in 4 cohorts. Each cohort will comprise of 20 subjects. Subjects will be dosed for 14 days.
Study Started
Aug 01
2016
Primary Completion
Mar 28
2017
Study Completion
Mar 28
2017
Results Posted
Feb 16
2021
Last Update
Feb 16
2021

Drug BAY3427080

  • Other names: NT-814

Drug Placebo (for BAY3427080)

BAY3427080 Placebo Placebo Comparator

50mg BAY3427080 Experimental

100mg BAY3427080 Experimental

150mg BAY3427080 Experimental

300mg BAY3427080 Experimental

Criteria

Inclusion Criteria:

Post-menopausal female subjects experiencing frequent moderate to severe hot flashes.Menopause will be defined as:

12 months of spontaneous amenorrhea;
OR at least 6 weeks' post-surgical bilateral oophorectomy with or without hysterectomy.

Exclusion Criteria:

BMI > 35kg/m2.
Any active comorbid disease, ECG or laboratory result deemed by the investigator to be clinically significant and which could impact safety during study conduct or that could interfere with the study evaluation, procedures or completion.
Use of prohibited medications defined in the protocol.
Inability or unwillingness to comply with study procedures or requirements.

Summary

Placebo Comparator

50 mg BAY3427080

100 mg BAY3427080

150 mg BAY3427080

300 mg BAY3427080

All Events

Event Type Organ System Event Term Placebo Comparator 50 mg BAY3427080 100 mg BAY3427080 150 mg BAY3427080 300 mg BAY3427080

Change From Baseline at Day 14 in Vital Signs: Oxygen Saturation

Oxygen Saturation was measured just prior to dosing (approx. 30 mins).

Placebo

Baseline

98.5
Percentage of Oxygen satuartion (Mean)
Standard Deviation: 1.098

Day 14 Change from Baseline

-0.61
Percentage of Oxygen satuartion (Mean)
Standard Deviation: 1.539

50 mg BAY3427080

Baseline

98.4
Percentage of Oxygen satuartion (Mean)
Standard Deviation: 1.404

Day 14 Change from Baseline

-0.73
Percentage of Oxygen satuartion (Mean)
Standard Deviation: 1.486

100 mg BAY3427080

Baseline

97.87
Percentage of Oxygen satuartion (Mean)
Standard Deviation: 1.727

Day 14 Change from Baseline

0.29
Percentage of Oxygen satuartion (Mean)
Standard Deviation: 2.091

150 mg BAY3427080

Baseline

97.67
Percentage of Oxygen satuartion (Mean)
Standard Deviation: 1.496

Day 14 Change from Baseline

0.2
Percentage of Oxygen satuartion (Mean)
Standard Deviation: 1.424

300 mg BAY3427080

Baseline

97.31
Percentage of Oxygen satuartion (Mean)
Standard Deviation: 1.251

Day 14 Change from Baseline

0.38
Percentage of Oxygen satuartion (Mean)
Standard Deviation: 1.193

Change From Baseline at Day 14 in Vital Signs: Oral Body Temperature

Temperature was measured just prior to dosing (approx. 30 mins).

Placebo

Baseline

36.77
Degree Celius (Mean)
Standard Deviation: 0.190

Day 14 Change from Baseline

-0.04
Degree Celius (Mean)
Standard Deviation: 0.243

50 mg BAY3427080

Baseline

36.65
Degree Celius (Mean)
Standard Deviation: 0.155

Day 14 Change from Baseline

0.06
Degree Celius (Mean)
Standard Deviation: 0.172

100 mg BAY3427080

Baseline

36.79
Degree Celius (Mean)
Standard Deviation: 0.162

Day 14 Change from Baseline

-0.09
Degree Celius (Mean)
Standard Deviation: 0.264

150 mg BAY3427080

Baseline

36.71
Degree Celius (Mean)
Standard Deviation: 0.168

Day 14 Change from Baseline

-0.01
Degree Celius (Mean)
Standard Deviation: 0.239

300 mg BAY3427080

Baseline

36.77
Degree Celius (Mean)
Standard Deviation: 0.361

Day 14 Change from Baseline

-0.05
Degree Celius (Mean)
Standard Deviation: 0.458

Number of Participants With Clinically Significant Abnormalities Detected Upon Physical Examination.

A physician or appropriately qualified delegate conducted a full physical examination. Clinically significance was decided by investigator. The findings are presented as abnormal (clinically significant).

Placebo

1.0
Participants

50 mg BAY3427080

100 mg BAY3427080

2.0
Participants

150 mg BAY3427080

1.0
Participants

300 mg BAY3427080

2.0
Participants

Number of Participants With Clinically Significant Abnormalities on the 12-lead ECGs

Reported results are cardiovascular system-examination findings at day 14. Clinically significance was decided by investigator. The findings are presented as abnormal (clinically significant).

Placebo

50 mg BAY3427080

100 mg BAY3427080

1.0
Participants

150 mg BAY3427080

300 mg BAY3427080

Change From Baseline at Day 14 in Vital Signs: Weight

Weight was measured just prior to dosing (approx. 30 mins).

Placebo

Baseline

73.25
Kilograms (Mean)
Standard Deviation: 10.115

Day 14 Change from Baseline

0.36
Kilograms (Mean)
Standard Deviation: 1.034

50 mg BAY3427080

Baseline

70.85
Kilograms (Mean)
Standard Deviation: 11.821

Day 14 Change from Baseline

0.51
Kilograms (Mean)
Standard Deviation: 0.983

100 mg BAY3427080

Baseline

73.47
Kilograms (Mean)
Standard Deviation: 14.934

Day 14 Change from Baseline

0.24
Kilograms (Mean)
Standard Deviation: 0.916

150 mg BAY3427080

Baseline

72.1
Kilograms (Mean)
Standard Deviation: 7.104

Day 14 Change from Baseline

0.15
Kilograms (Mean)
Standard Deviation: 0.926

300 mg BAY3427080

Baseline

72.73
Kilograms (Mean)
Standard Deviation: 12.047

Day 14 Change from Baseline

0.01
Kilograms (Mean)
Standard Deviation: 0.704

Maximum Observed Plasma Concentration (Cmax) of BAY3427080

Cmax is the maximum observed plasma concentration of BAY3427080 was presented. Blood samples were taken within 30 minutes prior to dose administration.

Placebo

50 mg BAY3427080

Day 1

502.62
ng/mL (Geometric Mean)
Geometric Coefficient of Variation: 90.19

Day 14

522.36
ng/mL (Geometric Mean)
Geometric Coefficient of Variation: 87.88

Day 7

548.6
ng/mL (Geometric Mean)
Geometric Coefficient of Variation: 57.47

100 mg BAY3427080

Day 1

731.69
ng/mL (Geometric Mean)
Geometric Coefficient of Variation: 110.58

Day 14

841.42
ng/mL (Geometric Mean)
Geometric Coefficient of Variation: 107.16

Day 7

809.48
ng/mL (Geometric Mean)
Geometric Coefficient of Variation: 116.58

150 mg BAY3427080

Day 1

911.48
ng/mL (Geometric Mean)
Geometric Coefficient of Variation: 148.28

Day 14

1188.19
ng/mL (Geometric Mean)
Geometric Coefficient of Variation: 131.20

Day 7

1173.5
ng/mL (Geometric Mean)
Geometric Coefficient of Variation: 95.14

300 mg BAY3427080

Day 1

1576.01
ng/mL (Geometric Mean)
Geometric Coefficient of Variation: 90.70

Day 14

2851.83
ng/mL (Geometric Mean)
Geometric Coefficient of Variation: 116.53

Day 7

2045.61
ng/mL (Geometric Mean)
Geometric Coefficient of Variation: 152.87

Time to Reach Maximum Observed Drug Concentration in Plasma (Tmax) of BAY3427080

Time of occurrence of Cmax.Time to reach maximum plasma concentration of BAY3427080 was presented. Blood samples for Tmax were taken within 30 minutes prior to dose administration.

Placebo

50 mg BAY3427080

Day 1

1.36
hr (Geometric Mean)
Geometric Coefficient of Variation: 40.01

Day 14

1.265
hr (Geometric Mean)
Geometric Coefficient of Variation: 46.32

Day 7

1.432
hr (Geometric Mean)
Geometric Coefficient of Variation: 39.25

100 mg BAY3427080

Day 1

1.32
hr (Geometric Mean)
Geometric Coefficient of Variation: 38.79

Day 14

1.445
hr (Geometric Mean)
Geometric Coefficient of Variation: 56.71

Day 7

1.623
hr (Geometric Mean)
Geometric Coefficient of Variation: 43.19

150 mg BAY3427080

Day 1

1.521
hr (Geometric Mean)
Geometric Coefficient of Variation: 41.95

Day 14

1.296
hr (Geometric Mean)
Geometric Coefficient of Variation: 23.35

Day 7

1.536
hr (Geometric Mean)
Geometric Coefficient of Variation: 40.08

300 mg BAY3427080

Day 1

1.471
hr (Geometric Mean)
Geometric Coefficient of Variation: 63.05

Day 14

1.342
hr (Geometric Mean)
Geometric Coefficient of Variation: 33.46

Day 7

1.754
hr (Geometric Mean)
Geometric Coefficient of Variation: 56.18

Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-∞) of BAY3427080

AUC from time zero extrapolated to infinity of BAY3427080 was presented. AUC0-∞ was only estimated following the Day 1 dose.

Placebo

50 mg BAY3427080

2018.68
hr*ng/mL (Geometric Mean)
Geometric Coefficient of Variation: 38.43

100 mg BAY3427080

1545.58
hr*ng/mL (Geometric Mean)
Geometric Coefficient of Variation: 3.49

150 mg BAY3427080

1151.87
hr*ng/mL (Geometric Mean)
Geometric Coefficient of Variation: 66.73

300 mg BAY3427080

6249.52
hr*ng/mL (Geometric Mean)
Geometric Coefficient of Variation: 101.01

Area Under the Concentration-time Curve (AUC) From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-τ) of BAY3427080

Area under the concentration-time curve (AUC) from time zero to the time of the last quantifiable concentration of BAY3427080 was presented. Blood samples for (AUC0-τ) were taken within 30 minutes prior to dose administration.

Placebo

50 mg BAY3427080

Day 1

1400.167
hr*ng/mL (Geometric Mean)
Geometric Coefficient of Variation: 67.87

Day 14

2341.55
hr*ng/mL (Geometric Mean)
Geometric Coefficient of Variation: 64.73

Day 7

2506.97
hr*ng/mL (Geometric Mean)
Geometric Coefficient of Variation: 48.05

100 mg BAY3427080

Day 1

2341.882
hr*ng/mL (Geometric Mean)
Geometric Coefficient of Variation: 71.19

Day 14

3542.41
hr*ng/mL (Geometric Mean)
Geometric Coefficient of Variation: 86.34

Day 7

4472.76
hr*ng/mL (Geometric Mean)
Geometric Coefficient of Variation: 63.83

150 mg BAY3427080

Day 1

3012.793
hr*ng/mL (Geometric Mean)
Geometric Coefficient of Variation: 97.74

Day 14

5163.5
hr*ng/mL (Geometric Mean)
Geometric Coefficient of Variation: 88.71

Day 7

6202.894
hr*ng/mL (Geometric Mean)
Geometric Coefficient of Variation: 43.92

300 mg BAY3427080

Day 1

6527.569
hr*ng/mL (Geometric Mean)
Geometric Coefficient of Variation: 70.50

Day 14

14822.86
hr*ng/mL (Geometric Mean)
Geometric Coefficient of Variation: 99.68

Day 7

12859.66
hr*ng/mL (Geometric Mean)
Geometric Coefficient of Variation: 85.47

Terminal Elimination Half-life (t½) of BAY3427080

Terminal elimination half-life of BAY3427080 was presented. Blood samples were taken within 30 minutes prior to dose administration.

Placebo

50 mg BAY3427080

Day 1

2.409
hr (Geometric Mean)
Geometric Coefficient of Variation: 34.15

Day 14

2.698
hr (Geometric Mean)
Geometric Coefficient of Variation: 21.64

Day 7

2.443
hr (Geometric Mean)
Geometric Coefficient of Variation: 9.33

100 mg BAY3427080

Day 1

1.903
hr (Geometric Mean)
Geometric Coefficient of Variation: 11.98

Day 14

2.042
hr (Geometric Mean)
Geometric Coefficient of Variation: None

Day 7

3.303
hr (Geometric Mean)
Geometric Coefficient of Variation: 21.20

150 mg BAY3427080

Day 1

3.965
hr (Geometric Mean)
Geometric Coefficient of Variation: 45.94

Day 14

21.593
hr (Geometric Mean)
Geometric Coefficient of Variation: 24.58

Day 7

3.482
hr (Geometric Mean)
Geometric Coefficient of Variation: 22.57

300 mg BAY3427080

Day 1

3.142
hr (Geometric Mean)
Geometric Coefficient of Variation: 18.92

Day 14

20.427
hr (Geometric Mean)
Geometric Coefficient of Variation: 22.85

Day 7

2.271
hr (Geometric Mean)
Geometric Coefficient of Variation: None

Apparent Clearance (CL/F) of BAY3427080

Apparent clearance of BAY3427080 was presented. Blood samples were taken within 30 minutes prior to dose administration.

Placebo

50 mg BAY3427080

Day 1

24.769
L/hr (Geometric Mean)
Geometric Coefficient of Variation: 38.43

Day 14

21.353
L/hr (Geometric Mean)
Geometric Coefficient of Variation: 64.73

Day 7

19.944
L/hr (Geometric Mean)
Geometric Coefficient of Variation: 48.05

100 mg BAY3427080

Day 1

64.7
L/hr (Geometric Mean)
Geometric Coefficient of Variation: 3.49

Day 14

28.229
L/hr (Geometric Mean)
Geometric Coefficient of Variation: 86.34

Day 7

22.358
L/hr (Geometric Mean)
Geometric Coefficient of Variation: 63.83

150 mg BAY3427080

Day 1

130.223
L/hr (Geometric Mean)
Geometric Coefficient of Variation: 66.73

Day 14

29.05
L/hr (Geometric Mean)
Geometric Coefficient of Variation: 88.71

Day 7

24.182
L/hr (Geometric Mean)
Geometric Coefficient of Variation: 43.92

300 mg BAY3427080

Day 1

48.004
L/hr (Geometric Mean)
Geometric Coefficient of Variation: 101.01

Day 14

20.239
L/hr (Geometric Mean)
Geometric Coefficient of Variation: 99.68

Day 7

23.329
L/hr (Geometric Mean)
Geometric Coefficient of Variation: 85.47

Number of Participants With Arrhythmias as Assessed by Continuous Holter Monitoring.

Holter monitors were supplied by iCardiac Technologies. Holter monitors were fitted to participants upon admission in clinic on Day -1 and Day 14 and remained in place until 24-hour assessments were completed.

Placebo

At least three monomorphic beats in a row (Day 14)

Average Hourly Daytime Heart Rate < 50 bpm (daytime defined as 7 am-10 pm)(Day-1)

Average Hourly Daytime Heart Rate < 50 bpm (daytime defined as 7 am-10 pm) (Day 14)

Frequent Supraventricular Premature Beats (APBs) (>100/24hrs) (Day-1)

2.0
Participants

Frequent Supraventricular Premature Beats (APBs) (>100/24hrs) (Day 14)

1.0
Participants

Frequent Ventricular Ectopic Beats (VEs) (> 200/24hrs) (Day-1)

1.0
Participants

Frequent Ventricular Ectopic Beats (VEs) (> 200/24hrs) (Day 14)

1.0
Participants

Other arrhythmias (Day-1)

17.0
Participants

Other arrhythmias (Day 14)

18.0
Participants

Presence of NSVT (Non-Sustained Ventricular Tachycardia) episodes (Day 14)

Second Degree AV Block - Type I (Day-1)

1.0
Participants

Second Degree AV Block - Type I (Day 14)

2.0
Participants

Second Degree AV Block - Type II(Day 14)

1.0
Participants

Sinus Bradycardia (HR < 40 bpm)

Sinus Bradycardia (HR < 40 bpm)(Day-1)

SupraVentricular Tachycardia (lasting > 10 beats) (Day-1)

4.0
Participants

SupraVentricular Tachycardia (lasting > 10 beats (Day 14)

3.0
Participants

50 mg BAY3427080

At least three monomorphic beats in a row (Day 14)

Average Hourly Daytime Heart Rate < 50 bpm (daytime defined as 7 am-10 pm)(Day-1)

Average Hourly Daytime Heart Rate < 50 bpm (daytime defined as 7 am-10 pm) (Day 14)

Frequent Supraventricular Premature Beats (APBs) (>100/24hrs) (Day-1)

1.0
Participants

Frequent Supraventricular Premature Beats (APBs) (>100/24hrs) (Day 14)

Frequent Ventricular Ectopic Beats (VEs) (> 200/24hrs) (Day-1)

4.0
Participants

Frequent Ventricular Ectopic Beats (VEs) (> 200/24hrs) (Day 14)

4.0
Participants

Other arrhythmias (Day-1)

13.0
Participants

Other arrhythmias (Day 14)

14.0
Participants

Presence of NSVT (Non-Sustained Ventricular Tachycardia) episodes (Day 14)

Second Degree AV Block - Type I (Day-1)

Second Degree AV Block - Type I (Day 14)

Second Degree AV Block - Type II(Day 14)

Sinus Bradycardia (HR < 40 bpm)

Sinus Bradycardia (HR < 40 bpm)(Day-1)

SupraVentricular Tachycardia (lasting > 10 beats) (Day-1)

5.0
Participants

SupraVentricular Tachycardia (lasting > 10 beats (Day 14)

3.0
Participants

100 mg BAY3427080

At least three monomorphic beats in a row (Day 14)

Average Hourly Daytime Heart Rate < 50 bpm (daytime defined as 7 am-10 pm)(Day-1)

1.0
Participants

Average Hourly Daytime Heart Rate < 50 bpm (daytime defined as 7 am-10 pm) (Day 14)

Frequent Supraventricular Premature Beats (APBs) (>100/24hrs) (Day-1)

3.0
Participants

Frequent Supraventricular Premature Beats (APBs) (>100/24hrs) (Day 14)

Frequent Ventricular Ectopic Beats (VEs) (> 200/24hrs) (Day-1)

1.0
Participants

Frequent Ventricular Ectopic Beats (VEs) (> 200/24hrs) (Day 14)

Other arrhythmias (Day-1)

15.0
Participants

Other arrhythmias (Day 14)

13.0
Participants

Presence of NSVT (Non-Sustained Ventricular Tachycardia) episodes (Day 14)

Second Degree AV Block - Type I (Day-1)

Second Degree AV Block - Type I (Day 14)

Second Degree AV Block - Type II(Day 14)

Sinus Bradycardia (HR < 40 bpm)

Sinus Bradycardia (HR < 40 bpm)(Day-1)

1.0
Participants

SupraVentricular Tachycardia (lasting > 10 beats) (Day-1)

4.0
Participants

SupraVentricular Tachycardia (lasting > 10 beats (Day 14)

1.0
Participants

150 mg BAY3427080

At least three monomorphic beats in a row (Day 14)

1.0
Participants

Average Hourly Daytime Heart Rate < 50 bpm (daytime defined as 7 am-10 pm)(Day-1)

Average Hourly Daytime Heart Rate < 50 bpm (daytime defined as 7 am-10 pm) (Day 14)

Frequent Supraventricular Premature Beats (APBs) (>100/24hrs) (Day-1)

Frequent Supraventricular Premature Beats (APBs) (>100/24hrs) (Day 14)

Frequent Ventricular Ectopic Beats (VEs) (> 200/24hrs) (Day-1)

Frequent Ventricular Ectopic Beats (VEs) (> 200/24hrs) (Day 14)

Other arrhythmias (Day-1)

15.0
Participants

Other arrhythmias (Day 14)

15.0
Participants

Presence of NSVT (Non-Sustained Ventricular Tachycardia) episodes (Day 14)

1.0
Participants

Second Degree AV Block - Type I (Day-1)

Second Degree AV Block - Type I (Day 14)

Second Degree AV Block - Type II(Day 14)

1.0
Participants

Sinus Bradycardia (HR < 40 bpm)

1.0
Participants

Sinus Bradycardia (HR < 40 bpm)(Day-1)

SupraVentricular Tachycardia (lasting > 10 beats) (Day-1)

2.0
Participants

SupraVentricular Tachycardia (lasting > 10 beats (Day 14)

1.0
Participants

300 mg BAY3427080

At least three monomorphic beats in a row (Day 14)

Average Hourly Daytime Heart Rate < 50 bpm (daytime defined as 7 am-10 pm)(Day-1)

Average Hourly Daytime Heart Rate < 50 bpm (daytime defined as 7 am-10 pm) (Day 14)

1.0
Participants

Frequent Supraventricular Premature Beats (APBs) (>100/24hrs) (Day-1)

Frequent Supraventricular Premature Beats (APBs) (>100/24hrs) (Day 14)

Frequent Ventricular Ectopic Beats (VEs) (> 200/24hrs) (Day-1)

2.0
Participants

Frequent Ventricular Ectopic Beats (VEs) (> 200/24hrs) (Day 14)

1.0
Participants

Other arrhythmias (Day-1)

12.0
Participants

Other arrhythmias (Day 14)

13.0
Participants

Presence of NSVT (Non-Sustained Ventricular Tachycardia) episodes (Day 14)

Second Degree AV Block - Type I (Day-1)

Second Degree AV Block - Type I (Day 14)

Second Degree AV Block - Type II(Day 14)

Sinus Bradycardia (HR < 40 bpm)

Sinus Bradycardia (HR < 40 bpm)(Day-1)

SupraVentricular Tachycardia (lasting > 10 beats) (Day-1)

1.0
Participants

SupraVentricular Tachycardia (lasting > 10 beats (Day 14)

1.0
Participants

Change From Baseline at Day 14 in Vital Signs: Diastolic Blood Pressure (Standing)

Diastolic Blood Pressure was measured just prior to dosing (approx. 30 mins) in standing position.

Placebo

Baseline

80.11
mmHg (Mean)
Standard Deviation: 4.702

Day 14 Change from Baseline

1.11
mmHg (Mean)
Standard Deviation: 9.579

50 mg BAY3427080

Baseline

76.07
mmHg (Mean)
Standard Deviation: 5.257

Day 14 Change from Baseline

2.53
mmHg (Mean)
Standard Deviation: 5.540

100 mg BAY3427080

Baseline

77.67
mmHg (Mean)
Standard Deviation: 11.462

Day 14 Change from Baseline

-0.07
mmHg (Mean)
Standard Deviation: 12.137

150 mg BAY3427080

Baseline

78.93
mmHg (Mean)
Standard Deviation: 6.147

Day 14 Change from Baseline

0.93
mmHg (Mean)
Standard Deviation: 7.216

300 mg BAY3427080

Baseline

77.92
mmHg (Mean)
Standard Deviation: 9.768

Day 14 Change from Baseline

1.62
mmHg (Mean)
Standard Deviation: 9.097

Change From Baseline at Day 14 in Vital Signs: Diastolic Blood Pressure (Sitting)

Diastolic Blood Pressure was measured just prior to dosing (approx. 30 mins) in sitting position.

Placebo

Baseline

77.72
mmHg (Mean)
Standard Deviation: 6.542

Day 14 Change from Baseline

0.11
mmHg (Mean)
Standard Deviation: 9.292

50 mg BAY3427080

Baseline

74.27
mmHg (Mean)
Standard Deviation: 6.239

Day 14 Change from Baseline

-0.53
mmHg (Mean)
Standard Deviation: 6.906

100 mg BAY3427080

Baseline

77.2
mmHg (Mean)
Standard Deviation: 10.705

Day 14 Change from Baseline

-0.79
mmHg (Mean)
Standard Deviation: 9.736

150 mg BAY3427080

Baseline

74.8
mmHg (Mean)
Standard Deviation: 6.774

Day 14 Change from Baseline

2.73
mmHg (Mean)
Standard Deviation: 9.384

300 mg BAY3427080

Baseline

74.15
mmHg (Mean)
Standard Deviation: 8.245

Day 14 Change from Baseline

1.77
mmHg (Mean)
Standard Deviation: 6.366

Change From Baseline at Day 14 in Vital Signs: Systolic Blood Pressure (Standing)

Systolic Blood Pressure was measured just prior to dosing (approx. 30 mins) in standing position.

Placebo

Baseline

117.83
mmHg (Mean)
Standard Deviation: 10.733

Day 14 Change from Baseline

5.11
mmHg (Mean)
Standard Deviation: 11.483

50 mg BAY3427080

Baseline

114.6
mmHg (Mean)
Standard Deviation: 8.675

Day 14 Change from Baseline

3.8
mmHg (Mean)
Standard Deviation: 13.311

100 mg BAY3427080

Baseline

121.33
mmHg (Mean)
Standard Deviation: 17.867

Day 14 Change from Baseline

-4.43
mmHg (Mean)
Standard Deviation: 18.744

150 mg BAY3427080

Baseline

118.87
mmHg (Mean)
Standard Deviation: 11.513

Day 14 Change from Baseline

0.33
mmHg (Mean)
Standard Deviation: 12.234

300 mg BAY3427080

Baseline

114.77
mmHg (Mean)
Standard Deviation: 15.095

Day 14 Change from Baseline

5.62
mmHg (Mean)
Standard Deviation: 16.536

Change From Baseline at Day 14 in Vital Signs: Systolic Blood Pressure (Sitting)

Systolic Blood Pressure was measured just prior to dosing (approx. 30 mins) in sitting position.

Placebo

Baseline

116.39
mmHg (Mean)
Standard Deviation: 11.304

Day 14 Change from Baseline

4.17
mmHg (Mean)
Standard Deviation: 11.868

50 mg BAY3427080

Baseline

113.8
mmHg (Mean)
Standard Deviation: 9.405

Day 14 Change from Baseline

0.2
mmHg (Mean)
Standard Deviation: 10.359

100 mg BAY3427080

Baseline

119.07
mmHg (Mean)
Standard Deviation: 15.931

Day 14 Change from Baseline

-2.79
mmHg (Mean)
Standard Deviation: 16.470

150 mg BAY3427080

Baseline

117.2
mmHg (Mean)
Standard Deviation: 10.638

Day 14 Change from Baseline

2.47
mmHg (Mean)
Standard Deviation: 16.890

300 mg BAY3427080

Baseline

114.15
mmHg (Mean)
Standard Deviation: 14.288

Day 14 Change from Baseline

5.62
mmHg (Mean)
Standard Deviation: 12.672

Change From Baseline at Day 14 in Vital Signs: Pulse Rate

Pulse rate was measured just prior to dosing (approx. 30 mins).

Placebo

Baseline

69.89
beats/min (Mean)
Standard Deviation: 8.629

Day 14 Change from Baseline

1.06
beats/min (Mean)
Standard Deviation: 8.271

50 mg BAY3427080

Baseline

66.0
beats/min (Mean)
Standard Deviation: 6.358

Day 14 Change from Baseline

-2.0
beats/min (Mean)
Standard Deviation: 8.027

100 mg BAY3427080

Baseline

69.2
beats/min (Mean)
Standard Deviation: 9.966

Day 14 Change from Baseline

0.14
beats/min (Mean)
Standard Deviation: 7.263

150 mg BAY3427080

Baseline

68.4
beats/min (Mean)
Standard Deviation: 4.611

Day 14 Change from Baseline

0.27
beats/min (Mean)
Standard Deviation: 8.388

300 mg BAY3427080

Baseline

72.62
beats/min (Mean)
Standard Deviation: 7.136

Day 14 Change from Baseline

-11.0
beats/min (Mean)
Standard Deviation: 9.618

Change From Baseline at Day 14 in Vital Signs: Respiratory Rate

Respiratory rate was measured just prior to dosing (approx. 30 mins).

Placebo

Baseline

15.39
breaths/min (Mean)
Standard Deviation: 1.378

Day 14 Change from Baseline

-0.11
breaths/min (Mean)
Standard Deviation: 2.220

50 mg BAY3427080

Baseline

15.47
breaths/min (Mean)
Standard Deviation: 1.727

Day 14 Change from Baseline

-0.4
breaths/min (Mean)
Standard Deviation: 2.197

100 mg BAY3427080

Baseline

15.73
breaths/min (Mean)
Standard Deviation: 1.624

Day 14 Change from Baseline

0.07
breaths/min (Mean)
Standard Deviation: 1.940

150 mg BAY3427080

Baseline

15.6
breaths/min (Mean)
Standard Deviation: 1.502

Day 14 Change from Baseline

-0.43
breaths/min (Mean)
Standard Deviation: 2.065

300 mg BAY3427080

Baseline

15.85
breaths/min (Mean)
Standard Deviation: 1.573

Day 14 Change from Baseline

-1.33
breaths/min (Mean)
Standard Deviation: 1.923

Change From Baseline at Day 15 for Laboratory Hormones Results : Adrenocorticotropic Hormone (ADTH) and Estradiol.

Blood samples for the assessment of ACTH and Estradiol were collected upon participants admission to the unit.

Placebo

Baseline (ADTH)

5.34
pmol/L (Mean)
Standard Deviation: 3.402

Baseline (Estradiol)

57.33
pmol/L (Mean)
Standard Deviation: 43.236

Day 15 Change from Baseline (ADTH)

-0.49
pmol/L (Mean)
Standard Deviation: 3.333

Day 15 Change from Baseline (Estradiol)

22.43
pmol/L (Mean)
Standard Deviation: 141.618

50 mg BAY3427080

Baseline (ADTH)

4.17
pmol/L (Mean)
Standard Deviation: 1.991

Baseline (Estradiol)

59.49
pmol/L (Mean)
Standard Deviation: 40.129

Day 15 Change from Baseline (ADTH)

-0.68
pmol/L (Mean)
Standard Deviation: 2.035

Day 15 Change from Baseline (Estradiol)

13.21
pmol/L (Mean)
Standard Deviation: 80.704

100 mg BAY3427080

Baseline (ADTH)

3.87
pmol/L (Mean)
Standard Deviation: 2.361

Baseline (Estradiol)

35.02
pmol/L (Mean)
Standard Deviation: 25.556

Day 15 Change from Baseline (ADTH)

0.84
pmol/L (Mean)
Standard Deviation: 1.914

Day 15 Change from Baseline (Estradiol)

0.53
pmol/L (Mean)
Standard Deviation: 3.172

150 mg BAY3427080

Baseline (ADTH)

3.55
pmol/L (Mean)
Standard Deviation: 2.360

Baseline (Estradiol)

43.83
pmol/L (Mean)
Standard Deviation: 31.270

Day 15 Change from Baseline (ADTH)

1.04
pmol/L (Mean)
Standard Deviation: 3.059

Day 15 Change from Baseline (Estradiol)

1.96
pmol/L (Mean)
Standard Deviation: 12.394

300 mg BAY3427080

Baseline (ADTH)

3.27
pmol/L (Mean)
Standard Deviation: 2.011

Baseline (Estradiol)

62.42
pmol/L (Mean)
Standard Deviation: 42.589

Day 15 Change from Baseline (ADTH)

1.67
pmol/L (Mean)
Standard Deviation: 3.059

Day 15 Change from Baseline (Estradiol)

-9.02
pmol/L (Mean)
Standard Deviation: 87.480

Change From Baseline at Day 15 for Laboratory Hormones Results: Follicle Stimulating Hormone

Blood samples for the assessment of Follicle Stimulating were collected upon participants admission to the unit.

Placebo

Baseline

76.01
IU/L (Mean)
Standard Deviation: 23.122

Day 15 Change from Baseline

5.98
IU/L (Mean)
Standard Deviation: 13.072

50 mg BAY3427080

Baseline

100.87
IU/L (Mean)
Standard Deviation: 36.813

Day 15 Change from Baseline

-2.29
IU/L (Mean)
Standard Deviation: 20.948

100 mg BAY3427080

Baseline

77.78
IU/L (Mean)
Standard Deviation: 20.132

Day 15 Change from Baseline

4.09
IU/L (Mean)
Standard Deviation: 8.353

150 mg BAY3427080

Baseline

88.77
IU/L (Mean)
Standard Deviation: 42.251

Day 15 Change from Baseline

6.73
IU/L (Mean)
Standard Deviation: 6.904

300 mg BAY3427080

Baseline

70.59
IU/L (Mean)
Standard Deviation: 17.046

Day 15 Change from Baseline

8.92
IU/L (Mean)
Standard Deviation: 13.409

Change From Baseline at Day 15 for Laboratory Hormones Results : Triiodothyronine Uptake

Blood samples for the assessment of Triiodothyronine were collected upon participants admission to the unit.

Placebo

Baseline

32.3
Percentage of T Uptake (Mean)
Standard Deviation: 3.5623

Day 15 Change from Baseline

-0.72
Percentage of T Uptake (Mean)
Standard Deviation: 0.7662

50 mg BAY3427080

Baseline

30.8
Percentage of T Uptake (Mean)
Standard Deviation: 2.4712

Day 15 Change from Baseline

-0.7
Percentage of T Uptake (Mean)
Standard Deviation: 0.2944

100 mg BAY3427080

Baseline

30.838
Percentage of T Uptake (Mean)
Standard Deviation: 1.7968

Day 15 Change from Baseline

0.143
Percentage of T Uptake (Mean)
Standard Deviation: 0.7115

150 mg BAY3427080

Baseline

30.671
Percentage of T Uptake (Mean)
Standard Deviation: 1.3060

Day 15 Change from Baseline

0.443
Percentage of T Uptake (Mean)
Standard Deviation: 1.0130

300 mg BAY3427080

Change From Baseline at Day 15 for Laboratory Hormones Results: Thyrotropin

Blood samples for the assessment of Thyrotropin were collected upon participants admission to the unit.

Placebo

Baseline

2.658
mIU/L (Mean)
Standard Deviation: 1.7584

Day 15 Change from Baseline

-0.959
mIU/L (Mean)
Standard Deviation: 1.3501

50 mg BAY3427080

Baseline

1.8
mIU/L (Mean)
Standard Deviation: 0.9830

Day 15 Change from Baseline

-0.571
mIU/L (Mean)
Standard Deviation: 0.8148

100 mg BAY3427080

Baseline

2.451
mIU/L (Mean)
Standard Deviation: 1.4811

Day 15 Change from Baseline

-0.648
mIU/L (Mean)
Standard Deviation: 0.5903

150 mg BAY3427080

Baseline

2.785
mIU/L (Mean)
Standard Deviation: 1.1449

Day 15 Change from Baseline

-0.823
mIU/L (Mean)
Standard Deviation: 1.0604

300 mg BAY3427080

Baseline

2.33
mIU/L (Mean)
Standard Deviation: 1.2658

Day 15 Change from Baseline

-0.616
mIU/L (Mean)
Standard Deviation: 1.1375

Change From Baseline at Day 15 for Laboratory Hormones Results : Cortisol, Testosterone, Thyroxine and Triiodothyronine

Blood samples for the assessment of Cortisol, Testosterone, Thyroxine and Triiodothyronine were collected upon participants admission to the unit.

Placebo

Baseline (Cortisol)

348.6
nmol/L (Mean)
Standard Deviation: 156.496

Baseline (Testosterone)

0.744
nmol/L (Mean)
Standard Deviation: 0.3850

Baseline(Thyroxine)

95.44
nmol/L (Mean)
Standard Deviation: 14.576

Baseline(Triiodothyronine)

1.865
nmol/L (Mean)
Standard Deviation: 0.14131

Day 15 Change from Baseline (Cortisol)

15.94
nmol/L (Mean)
Standard Deviation: 193.564

Day 15 Change from Baseline (Testosterone)

0.057
nmol/L (Mean)
Standard Deviation: 0.3567

Day 15 Change from Baseline(Thyroxine)

-3.78
nmol/L (Mean)
Standard Deviation: 14.771

Day 15 Change from Baseline (Triiodothyronine)

-0.19
nmol/L (Mean)
Standard Deviation: 0.3171

50 mg BAY3427080

Baseline (Cortisol)

337.16
nmol/L (Mean)
Standard Deviation: 177.507

Baseline (Testosterone)

0.666
nmol/L (Mean)
Standard Deviation: 0.6230

Baseline(Thyroxine)

95.66
nmol/L (Mean)
Standard Deviation: 15.203

Baseline(Triiodothyronine)

2.06
nmol/L (Mean)
Standard Deviation: 0.3174

Day 15 Change from Baseline (Cortisol)

-23.32
nmol/L (Mean)
Standard Deviation: 172.685

Day 15 Change from Baseline (Testosterone)

0.024
nmol/L (Mean)
Standard Deviation: 0.2578

Day 15 Change from Baseline(Thyroxine)

-1.28
nmol/L (Mean)
Standard Deviation: 8.127

Day 15 Change from Baseline (Triiodothyronine)

-0.141
nmol/L (Mean)
Standard Deviation: 0.2742

100 mg BAY3427080

Baseline (Cortisol)

345.91
nmol/L (Mean)
Standard Deviation: 173.302

Baseline (Testosterone)

0.517
nmol/L (Mean)
Standard Deviation: 0.2317

Baseline(Thyroxine)

96.11
nmol/L (Mean)
Standard Deviation: 14.645

Baseline(Triiodothyronine)

1.98
nmol/L (Mean)
Standard Deviation: 0.2916

Day 15 Change from Baseline (Cortisol)

68.05
nmol/L (Mean)
Standard Deviation: 170.121

Day 15 Change from Baseline (Testosterone)

0.696
nmol/L (Mean)
Standard Deviation: 0.3367

Day 15 Change from Baseline(Thyroxine)

-10.67
nmol/L (Mean)
Standard Deviation: 26.324

Day 15 Change from Baseline (Triiodothyronine)

-0.407
nmol/L (Mean)
Standard Deviation: 0.2180

150 mg BAY3427080

Baseline (Cortisol)

251.66
nmol/L (Mean)
Standard Deviation: 144.743

Baseline (Testosterone)

0.433
nmol/L (Mean)
Standard Deviation: 0.2961

Baseline(Thyroxine)

86.41
nmol/L (Mean)
Standard Deviation: 16.116

Baseline(Triiodothyronine)

1.776
nmol/L (Mean)
Standard Deviation: 0.4510

Day 15 Change from Baseline (Cortisol)

92.02
nmol/L (Mean)
Standard Deviation: 159.464

Day 15 Change from Baseline (Testosterone)

0.48
nmol/L (Mean)
Standard Deviation: 0.4589

Day 15 Change from Baseline(Thyroxine)

6.53
nmol/L (Mean)
Standard Deviation: 9.546

Day 15 Change from Baseline (Triiodothyronine)

-0.148
nmol/L (Mean)
Standard Deviation: 0.1883

300 mg BAY3427080

Baseline (Cortisol)

230.42
nmol/L (Mean)
Standard Deviation: 74.560

Baseline (Testosterone)

0.611
nmol/L (Mean)
Standard Deviation: 0.4271

Baseline(Thyroxine)

94.16
nmol/L (Mean)
Standard Deviation: 22.180

Baseline(Triiodothyronine)

2.163
nmol/L (Mean)
Standard Deviation: 0.6008

Day 15 Change from Baseline (Cortisol)

127.2
nmol/L (Mean)
Standard Deviation: 208.452

Day 15 Change from Baseline (Testosterone)

0.524
nmol/L (Mean)
Standard Deviation: 0.2905

Day 15 Change from Baseline(Thyroxine)

0.88
nmol/L (Mean)
Standard Deviation: 13.720

Day 15 Change from Baseline (Triiodothyronine)

-0.416
nmol/L (Mean)
Standard Deviation: 0.5359

Change From Baseline at Day 14 for Clinical Laboratory Parameters LIPIDS : Cholesterol, Triglycerides, HDL Cholesterol and LDL Cholesterol.

Blood samples for the assessment of Cholesterol, Triglycerides,high-density lipoprotein (HDL)Cholesterol and low-density lipoprotein (LDL) Cholesterol were collected upon participants admission to the unit.

100 mg BAY3427080

Baseline (Cholesterol)

5.391
mmol/L (Mean)
Standard Deviation: 0.7346

Baseline(HDL Cholesterol)

1.7444
mmol/L (Mean)
Standard Deviation: 0.6563

Baseline( LDL Cholesterol)

3.172
mmol/L (Mean)
Standard Deviation: 0.7654

Baseline (Triglycerides)

1.131
mmol/L (Mean)
Standard Deviation: 0.5889

Day 14 Change from Baseline (Cholesterol)

-0.205
mmol/L (Mean)
Standard Deviation: 0.8981

Day 14 Change from Baseline( HDL Cholesterol)

-0.056
mmol/L (Mean)
Standard Deviation: 0.2559

Day 14 Change from Baseline ( LDL Cholesterol)

-0.119
mmol/L (Mean)
Standard Deviation: 0.6747

Day 14 Change from Baseline (Triglycerides)

-0.116
mmol/L (Mean)
Standard Deviation: 0.5247

150 mg BAY3427080

Baseline (Cholesterol)

5.804
mmol/L (Mean)
Standard Deviation: 0.6462

Baseline(HDL Cholesterol)

1.768
mmol/L (Mean)
Standard Deviation: 0.4716

Baseline( LDL Cholesterol)

3.625
mmol/L (Mean)
Standard Deviation: 0.7188

Baseline (Triglycerides)

1.329
mmol/L (Mean)
Standard Deviation: 0.6245

Day 14 Change from Baseline (Cholesterol)

-0.185
mmol/L (Mean)
Standard Deviation: 0.6386

Day 14 Change from Baseline( HDL Cholesterol)

-0.147
mmol/L (Mean)
Standard Deviation: 0.1546

Day 14 Change from Baseline ( LDL Cholesterol)

-0.038
mmol/L (Mean)
Standard Deviation: 0.6490

Day 14 Change from Baseline (Triglycerides)

-0.029
mmol/L (Mean)
Standard Deviation: 0.4178

300 mg BAY3427080

Baseline (Cholesterol)

5.393
mmol/L (Mean)
Standard Deviation: 0.9008

Baseline(HDL Cholesterol)

1.449
mmol/L (Mean)
Standard Deviation: 0.2752

Baseline( LDL Cholesterol)

3.552
mmol/L (Mean)
Standard Deviation: 1.1088

Baseline (Triglycerides)

1.353
mmol/L (Mean)
Standard Deviation: 0.5540

Day 14 Change from Baseline (Cholesterol)

-0.321
mmol/L (Mean)
Standard Deviation: 0.6790

Day 14 Change from Baseline( HDL Cholesterol)

-0.158
mmol/L (Mean)
Standard Deviation: 0.3132

Day 14 Change from Baseline ( LDL Cholesterol)

-0.053
mmol/L (Mean)
Standard Deviation: 0.5944

Day 14 Change from Baseline (Triglycerides)

-0.172
mmol/L (Mean)
Standard Deviation: 0.5633

Placebo

Baseline (Cholesterol)

5.434
mmol/L (Mean)
Standard Deviation: 1.0223

Baseline(HDL Cholesterol)

1.717
mmol/L (Mean)
Standard Deviation: 0.4525

Baseline( LDL Cholesterol)

3.226
mmol/L (Mean)
Standard Deviation: 1.0485

Baseline (Triglycerides)

1.163
mmol/L (Mean)
Standard Deviation: 0.5796

Day 14 Change from Baseline (Cholesterol)

0.088
mmol/L (Mean)
Standard Deviation: 0.8629

Day 14 Change from Baseline( HDL Cholesterol)

-0.167
mmol/L (Mean)
Standard Deviation: 0.2824

Day 14 Change from Baseline ( LDL Cholesterol)

-0.013
mmol/L (Mean)
Standard Deviation: 0.3926

Day 14 Change from Baseline (Triglycerides)

0.048
mmol/L (Mean)
Standard Deviation: 0.4936

50 mg BAY3427080

Baseline (Cholesterol)

5.471
mmol/L (Mean)
Standard Deviation: 0.6592

Baseline(HDL Cholesterol)

1.879
mmol/L (Mean)
Standard Deviation: 0.4052

Baseline( LDL Cholesterol)

3.125
mmol/L (Mean)
Standard Deviation: 0.8436

Baseline (Triglycerides)

1.185
mmol/L (Mean)
Standard Deviation: 0.5036

Day 14 Change from Baseline (Cholesterol)

-0.061
mmol/L (Mean)
Standard Deviation: 0.4761

Day 14 Change from Baseline( HDL Cholesterol)

-0.219
mmol/L (Mean)
Standard Deviation: 0.2015

Day 14 Change from Baseline ( LDL Cholesterol)

0.184
mmol/L (Mean)
Standard Deviation: 0.2958

Day 14 Change from Baseline (Triglycerides)

-0.071
mmol/L (Mean)
Standard Deviation: 0.4725

Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Immature Granulocytes.

Blood samples for the assessment of Neutrophils/Leukocytes, Lymphocytes /Leukocytes, Monocytes/Leukocytes, Eosinophils/Leukocytes, Basophils/Leukocytes and Immature Granulocytes/ Leukocytes were collected upon participants admission to the unit.

Placebo

Baseline(Basophils/ Leukocytes)

0.61
Percentage of total white blood cells (Mean)
Standard Deviation: 0.263

Baseline ( Eosinophils/ Leukocytes)

2.83
Percentage of total white blood cells (Mean)
Standard Deviation: 2.433

Baseline( Immature Granulocytes/ Leukocytes)

0.15
Percentage of total white blood cells (Mean)
Standard Deviation: 0.084

Baseline (Lymphocytes/ Leukocytes)

32.4
Percentage of total white blood cells (Mean)
Standard Deviation: 7.098

Baseline ( Monocytes / Leukocytes )

7.58
Percentage of total white blood cells (Mean)
Standard Deviation: 1.592

Baseline (Neutrophils/ Leukocytes)

56.53
Percentage of total white blood cells (Mean)
Standard Deviation: 7.700

Day 14 Change from Baseline (Basophils/ Leukocytes)

-0.13
Percentage of total white blood cells (Mean)
Standard Deviation: 0.181

Day 14 Change from Baseline(Eosinophils/ Leukocytes)

0.02
Percentage of total white blood cells (Mean)
Standard Deviation: 1.316

Day 14 Change from Baseline( Immature Granulocytes/ Leukocytes)

0.03
Percentage of total white blood cells (Mean)
Standard Deviation: 0.082

Day 14 Change from Baseline(Lymphocytes / Leukocytes)

0.18
Percentage of total white blood cells (Mean)
Standard Deviation: 5.791

Day 14 Change from Baseline( Monocytes/ Leukocytes)

0.22
Percentage of total white blood cells (Mean)
Standard Deviation: 1.947

Day 14 Change from Baseline (Neutrophils/ Leukocytes)

-0.29
Percentage of total white blood cells (Mean)
Standard Deviation: 7.788

50 mg BAY3427080

Baseline(Basophils/ Leukocytes)

0.55
Percentage of total white blood cells (Mean)
Standard Deviation: 0.177

Baseline ( Eosinophils/ Leukocytes)

3.04
Percentage of total white blood cells (Mean)
Standard Deviation: 3.352

Baseline( Immature Granulocytes/ Leukocytes)

0.25
Percentage of total white blood cells (Mean)
Standard Deviation: 0.100

Baseline (Lymphocytes/ Leukocytes)

35.57
Percentage of total white blood cells (Mean)
Standard Deviation: 5.439

Baseline ( Monocytes / Leukocytes )

7.47
Percentage of total white blood cells (Mean)
Standard Deviation: 1.379

Baseline (Neutrophils/ Leukocytes)

53.31
Percentage of total white blood cells (Mean)
Standard Deviation: 4.994

Day 14 Change from Baseline (Basophils/ Leukocytes)

-0.07
Percentage of total white blood cells (Mean)
Standard Deviation: 0.111

Day 14 Change from Baseline(Eosinophils/ Leukocytes)

0.29
Percentage of total white blood cells (Mean)
Standard Deviation: 0.961

Day 14 Change from Baseline( Immature Granulocytes/ Leukocytes)

-0.05
Percentage of total white blood cells (Mean)
Standard Deviation: 0.100

Day 14 Change from Baseline(Lymphocytes / Leukocytes)

-2.46
Percentage of total white blood cells (Mean)
Standard Deviation: 5.667

Day 14 Change from Baseline( Monocytes/ Leukocytes)

-0.15
Percentage of total white blood cells (Mean)
Standard Deviation: 1.751

Day 14 Change from Baseline (Neutrophils/ Leukocytes)

2.41
Percentage of total white blood cells (Mean)
Standard Deviation: 6.119

100 mg BAY3427080

Baseline(Basophils/ Leukocytes)

0.66
Percentage of total white blood cells (Mean)
Standard Deviation: 0.295

Baseline ( Eosinophils/ Leukocytes)

2.64
Percentage of total white blood cells (Mean)
Standard Deviation: 1.422

Baseline( Immature Granulocytes/ Leukocytes)

0.2
Percentage of total white blood cells (Mean)
Standard Deviation: 0.151

Baseline (Lymphocytes/ Leukocytes)

33.33
Percentage of total white blood cells (Mean)
Standard Deviation: 8.024

Baseline ( Monocytes / Leukocytes )

7.62
Percentage of total white blood cells (Mean)
Standard Deviation: 1.591

Baseline (Neutrophils/ Leukocytes)

55.65
Percentage of total white blood cells (Mean)
Standard Deviation: 8.318

Day 14 Change from Baseline (Basophils/ Leukocytes)

-0.14
Percentage of total white blood cells (Mean)
Standard Deviation: 0.122

Day 14 Change from Baseline(Eosinophils/ Leukocytes)

0.06
Percentage of total white blood cells (Mean)
Standard Deviation: 0.794

Day 14 Change from Baseline( Immature Granulocytes/ Leukocytes)

0.09
Percentage of total white blood cells (Mean)
Standard Deviation: 0.157

Day 14 Change from Baseline(Lymphocytes / Leukocytes)

-0.11
Percentage of total white blood cells (Mean)
Standard Deviation: 4.763

Day 14 Change from Baseline( Monocytes/ Leukocytes)

0.65
Percentage of total white blood cells (Mean)
Standard Deviation: 1.291

Day 14 Change from Baseline (Neutrophils/ Leukocytes)

-0.5
Percentage of total white blood cells (Mean)
Standard Deviation: 5.047

150 mg BAY3427080

Baseline(Basophils/ Leukocytes)

0.51
Percentage of total white blood cells (Mean)
Standard Deviation: 0.223

Baseline ( Eosinophils/ Leukocytes)

2.61
Percentage of total white blood cells (Mean)
Standard Deviation: 1.170

Baseline( Immature Granulocytes/ Leukocytes)

0.13
Percentage of total white blood cells (Mean)
Standard Deviation: 0.111

Baseline (Lymphocytes/ Leukocytes)

34.33
Percentage of total white blood cells (Mean)
Standard Deviation: 7.444

Baseline ( Monocytes / Leukocytes )

7.71
Percentage of total white blood cells (Mean)
Standard Deviation: 1.762

Baseline (Neutrophils/ Leukocytes)

54.78
Percentage of total white blood cells (Mean)
Standard Deviation: 8.610

Day 14 Change from Baseline (Basophils/ Leukocytes)

0.01
Percentage of total white blood cells (Mean)
Standard Deviation: 0.209

Day 14 Change from Baseline(Eosinophils/ Leukocytes)

0.33
Percentage of total white blood cells (Mean)
Standard Deviation: 0.538

Day 14 Change from Baseline( Immature Granulocytes/ Leukocytes)

Day 14 Change from Baseline(Lymphocytes / Leukocytes)

0.59
Percentage of total white blood cells (Mean)
Standard Deviation: 5.835

Day 14 Change from Baseline( Monocytes/ Leukocytes)

0.05
Percentage of total white blood cells (Mean)
Standard Deviation: 2.758

Day 14 Change from Baseline (Neutrophils/ Leukocytes)

-0.98
Percentage of total white blood cells (Mean)
Standard Deviation: 7.116

300 mg BAY3427080

Baseline(Basophils/ Leukocytes)

0.56
Percentage of total white blood cells (Mean)
Standard Deviation: 0.373

Baseline ( Eosinophils/ Leukocytes)

3.05
Percentage of total white blood cells (Mean)
Standard Deviation: 1.979

Baseline( Immature Granulocytes/ Leukocytes)

0.15
Percentage of total white blood cells (Mean)
Standard Deviation: 0.084

Baseline (Lymphocytes/ Leukocytes)

36.78
Percentage of total white blood cells (Mean)
Standard Deviation: 10.446

Baseline ( Monocytes / Leukocytes )

8.62
Percentage of total white blood cells (Mean)
Standard Deviation: 3.276

Baseline (Neutrophils/ Leukocytes)

50.92
Percentage of total white blood cells (Mean)
Standard Deviation: 10.316

Day 14 Change from Baseline (Basophils/ Leukocytes)

-0.05
Percentage of total white blood cells (Mean)
Standard Deviation: 0.307

Day 14 Change from Baseline(Eosinophils/ Leukocytes)

-0.24
Percentage of total white blood cells (Mean)
Standard Deviation: 1.189

Day 14 Change from Baseline( Immature Granulocytes/ Leukocytes)

0.03
Percentage of total white blood cells (Mean)
Standard Deviation: 0.137

Day 14 Change from Baseline(Lymphocytes / Leukocytes)

2.75
Percentage of total white blood cells (Mean)
Standard Deviation: 10.926

Day 14 Change from Baseline( Monocytes/ Leukocytes)

0.22
Percentage of total white blood cells (Mean)
Standard Deviation: 3.850

Day 14 Change from Baseline (Neutrophils/ Leukocytes)

-2.69
Percentage of total white blood cells (Mean)
Standard Deviation: 10.614

Change From Baseline at Day 14 for Clinical Laboratory Parameters HEMATOLOGY: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets.

Blood samples for the assessment of Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Immature Granulocytes and Platelets were collected upon participant's admission to the unit.

Placebo

Baseline(Basophils)

0.041
10^9*cells/L (Mean)
Standard Deviation: 0.0305

Baseline ( Eosinophils)

0.202
10^9*cells/L (Mean)
Standard Deviation: 0.2325

Baseline( Immature Granulocytes)

Baseline( Leukocytes)

6.73
10^9*cells/L (Mean)
Standard Deviation: 1.372

Baseline (Lymphocytes)

2.148
10^9*cells/L (Mean)
Standard Deviation: 0.4905

Baseline ( Monocytes)

0.499
10^9*cells/L (Mean)
Standard Deviation: 0.0984

Baseline (Neutrophils)

3.847
10^9*cells/L (Mean)
Standard Deviation: 1.0899

Baseline (Platelets )

263.4
10^9*cells/L (Mean)
Standard Deviation: 59.66

Day 14 Change from Baseline(Basophils)

-0.008
10^9*cells/L (Mean)
Standard Deviation: 0.0148

Day 14 Change from Baseline(Eosinophils)

-0.017
10^9*cells/L (Mean)
Standard Deviation: 0.0995

Day 14 Change from Baseline( Immature Granulocytes)

Day 14 Change from Baseline( Leukocytes)

-0.6
10^9*cells/L (Mean)
Standard Deviation: 1.299

Day 14 Change from Baseline (Lymphocytes)

-0.172
10^9*cells/L (Mean)
Standard Deviation: 0.2900

Day 14 Change from Baseline( Monocytes)

-0.033
10^9*cells/L (Mean)
Standard Deviation: 0.1117

Day 14 Change from Baseline (Neutrophils )

-0.374
10^9*cells/L (Mean)
Standard Deviation: 1.1794

Day 14 Change from Baseline(Platelets )

8.1
10^9*cells/L (Mean)
Standard Deviation: 17.77

50 mg BAY3427080

Baseline(Basophils)

0.031
10^9*cells/L (Mean)
Standard Deviation: 0.0264

Baseline ( Eosinophils)

0.185
10^9*cells/L (Mean)
Standard Deviation: 0.1814

Baseline( Immature Granulocytes)

Baseline( Leukocytes)

6.54
10^9*cells/L (Mean)
Standard Deviation: 1.613

Baseline (Lymphocytes)

2.341
10^9*cells/L (Mean)
Standard Deviation: 0.7009

Baseline ( Monocytes)

0.479
10^9*cells/L (Mean)
Standard Deviation: 0.1051

Baseline (Neutrophils)

3.493
10^9*cells/L (Mean)
Standard Deviation: 0.9737

Baseline (Platelets )

249.1
10^9*cells/L (Mean)
Standard Deviation: 61.67

Day 14 Change from Baseline(Basophils)

-0.007
10^9*cells/L (Mean)
Standard Deviation: 0.0090

Day 14 Change from Baseline(Eosinophils)

0.021
10^9*cells/L (Mean)
Standard Deviation: 0.0719

Day 14 Change from Baseline( Immature Granulocytes)

Day 14 Change from Baseline( Leukocytes)

-0.27
10^9*cells/L (Mean)
Standard Deviation: 1.134

Day 14 Change from Baseline (Lymphocytes)

-0.301
10^9*cells/L (Mean)
Standard Deviation: 0.5336

Day 14 Change from Baseline( Monocytes)

-0.03
10^9*cells/L (Mean)
Standard Deviation: 0.1324

Day 14 Change from Baseline (Neutrophils )

0.072
10^9*cells/L (Mean)
Standard Deviation: 0.7422

Day 14 Change from Baseline(Platelets )

4.5
10^9*cells/L (Mean)
Standard Deviation: 33.83

100 mg BAY3427080

Baseline(Basophils)

0.028
10^9*cells/L (Mean)
Standard Deviation: 0.0321

Baseline ( Eosinophils)

0.177
10^9*cells/L (Mean)
Standard Deviation: 0.1090

Baseline( Immature Granulocytes)

Baseline( Leukocytes)

6.75
10^9*cells/L (Mean)
Standard Deviation: 1.245

Baseline (Lymphocytes)

2.242
10^9*cells/L (Mean)
Standard Deviation: 0.6199

Baseline ( Monocytes)

0.505
10^9*cells/L (Mean)
Standard Deviation: 0.0990

Baseline (Neutrophils)

3.779
10^9*cells/L (Mean)
Standard Deviation: 0.9332

Baseline (Platelets )

269.8
10^9*cells/L (Mean)
Standard Deviation: 61.40

Day 14 Change from Baseline(Basophils)

-0.001
10^9*cells/L (Mean)
Standard Deviation: 0.0305

Day 14 Change from Baseline(Eosinophils)

-0.006
10^9*cells/L (Mean)
Standard Deviation: 0.0549

Day 14 Change from Baseline( Immature Granulocytes)

Day 14 Change from Baseline( Leukocytes)

-0.34
10^9*cells/L (Mean)
Standard Deviation: 0.686

Day 14 Change from Baseline (Lymphocytes)

-0.107
10^9*cells/L (Mean)
Standard Deviation: 0.3652

Day 14 Change from Baseline( Monocytes)

0.019
10^9*cells/L (Mean)
Standard Deviation: 0.0895

Day 14 Change from Baseline (Neutrophils )

-0.246
10^9*cells/L (Mean)
Standard Deviation: 0.5487

Day 14 Change from Baseline(Platelets )

13.5
10^9*cells/L (Mean)
Standard Deviation: 29.67

150 mg BAY3427080

Baseline(Basophils)

0.027
10^9*cells/L (Mean)
Standard Deviation: 0.0301

Baseline ( Eosinophils)

0.177
10^9*cells/L (Mean)
Standard Deviation: 0.0954

Baseline( Immature Granulocytes)

Baseline( Leukocytes)

6.78
10^9*cells/L (Mean)
Standard Deviation: 1.307

Baseline (Lymphocytes)

2.32
10^9*cells/L (Mean)
Standard Deviation: 0.6467

Baseline ( Monocytes)

0.524
10^9*cells/L (Mean)
Standard Deviation: 0.1410

Baseline (Neutrophils)

3.745
10^9*cells/L (Mean)
Standard Deviation: 0.9686

Baseline (Platelets )

261.9
10^9*cells/L (Mean)
Standard Deviation: 46.91

Day 14 Change from Baseline(Basophils)

-0.01
10^9*cells/L (Mean)
Standard Deviation: 0.0259

Day 14 Change from Baseline(Eosinophils)

0.005
10^9*cells/L (Mean)
Standard Deviation: 0.0436

Day 14 Change from Baseline( Immature Granulocytes)

Day 14 Change from Baseline( Leukocytes)

-0.8
10^9*cells/L (Mean)
Standard Deviation: 1.011

Day 14 Change from Baseline (Lymphocytes)

-0.237
10^9*cells/L (Mean)
Standard Deviation: 0.3901

Day 14 Change from Baseline( Monocytes)

-0.057
10^9*cells/L (Mean)
Standard Deviation: 0.1941

Day 14 Change from Baseline (Neutrophils )

-0.539
10^9*cells/L (Mean)
Standard Deviation: 0.9017

Day 14 Change from Baseline(Platelets )

21.6
10^9*cells/L (Mean)
Standard Deviation: 24.58

300 mg BAY3427080

Baseline(Basophils)

0.03
10^9*cells/L (Mean)
Standard Deviation: 0.327

Baseline ( Eosinophils)

0.208
10^9*cells/L (Mean)
Standard Deviation: 0.1592

Baseline( Immature Granulocytes)

Baseline( Leukocytes)

6.6
10^9*cells/L (Mean)
Standard Deviation: 1.896

Baseline (Lymphocytes)

2.429
10^9*cells/L (Mean)
Standard Deviation: 0.9032

Baseline ( Monocytes)

0.534
10^9*cells/L (Mean)
Standard Deviation: 0.1552

Baseline (Neutrophils)

3.394
10^9*cells/L (Mean)
Standard Deviation: 1.3264

Baseline (Platelets )

258.2
10^9*cells/L (Mean)
Standard Deviation: 52.57

Day 14 Change from Baseline(Basophils)

-0.002
10^9*cells/L (Mean)
Standard Deviation: 0.0060

Day 14 Change from Baseline(Eosinophils)

-0.028
10^9*cells/L (Mean)
Standard Deviation: 0.1155

Day 14 Change from Baseline( Immature Granulocytes)

Day 14 Change from Baseline( Leukocytes)

-0.06
10^9*cells/L (Mean)
Standard Deviation: 1.650

Day 14 Change from Baseline (Lymphocytes)

0.142
10^9*cells/L (Mean)
Standard Deviation: 0.6749

Day 14 Change from Baseline( Monocytes)

0.002
10^9*cells/L (Mean)
Standard Deviation: 0.1643

Day 14 Change from Baseline (Neutrophils )

-0.186
10^9*cells/L (Mean)
Standard Deviation: 1.4444

Day 14 Change from Baseline(Platelets )

20.8
10^9*cells/L (Mean)
Standard Deviation: 74.35

Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Hemoglobin and Erythrocytes Mean Corpuscular Hemoglobin Concentration

Blood samples for the assessment of Hemoglobin and Erythrocytes Mean Corpuscular Hemoglobin (HB)concentration were collected upon participants admission to the unit.

Placebo

Baseline (Erythrocytes Mean Corpuscular HB concentration )

328.5
g/L (Mean)
Standard Deviation: 10.30

Baseline (Hemoglobin)

128.9
g/L (Mean)
Standard Deviation: 8.53

Day 14 Change from Baseline (Erythrocytes Mean Corpuscular HB concentration)

-0.4
g/L (Mean)
Standard Deviation: 5.21

Day 14 Change from Baseline (Hemoglobin)

-11.8
g/L (Mean)
Standard Deviation: 4.99

50 mg BAY3427080

Baseline (Erythrocytes Mean Corpuscular HB concentration )

335.2
g/L (Mean)
Standard Deviation: 9.42

Baseline (Hemoglobin)

132.4
g/L (Mean)
Standard Deviation: 10.64

Day 14 Change from Baseline (Erythrocytes Mean Corpuscular HB concentration)

-2.5
g/L (Mean)
Standard Deviation: 2.34

Day 14 Change from Baseline (Hemoglobin)

-9.0
g/L (Mean)
Standard Deviation: 7.14

100 mg BAY3427080

Baseline (Erythrocytes Mean Corpuscular HB concentration )

329.0
g/L (Mean)
Standard Deviation: 10.22

Baseline (Hemoglobin)

128.7
g/L (Mean)
Standard Deviation: 7.82

Day 14 Change from Baseline (Erythrocytes Mean Corpuscular HB concentration)

-2.3
g/L (Mean)
Standard Deviation: 6.94

Day 14 Change from Baseline (Hemoglobin)

-14.6
g/L (Mean)
Standard Deviation: 5.98

150 mg BAY3427080

Baseline (Erythrocytes Mean Corpuscular HB concentration )

328.2
g/L (Mean)
Standard Deviation: 7.51

Baseline (Hemoglobin)

127.7
g/L (Mean)
Standard Deviation: 8.60

Day 14 Change from Baseline (Erythrocytes Mean Corpuscular HB concentration)

-0.8
g/L (Mean)
Standard Deviation: 3.41

Day 14 Change from Baseline (Hemoglobin)

-13.9
g/L (Mean)
Standard Deviation: 4.66

300 mg BAY3427080

Baseline (Erythrocytes Mean Corpuscular HB concentration )

326.8
g/L (Mean)
Standard Deviation: 10.27

Baseline (Hemoglobin)

132.2
g/L (Mean)
Standard Deviation: 12.60

Day 14 Change from Baseline (Erythrocytes Mean Corpuscular HB concentration)

3.2
g/L (Mean)
Standard Deviation: 4.62

Day 14 Change from Baseline (Hemoglobin)

-12.1
g/L (Mean)
Standard Deviation: 6.58

Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes

Blood samples for the assessment of Erythrocytes were collected upon participants admission to the unit.

Placebo

Baseline

4.467
10^12*cells/L (Mean)
Standard Deviation: 0.2503

Day 14 Change from Baseline

-0.421
10^12*cells/L (Mean)
Standard Deviation: 0.1750

50 mg BAY3427080

Baseline

4.525
10^12*cells/L (Mean)
Standard Deviation: 0.2212

Day 14 Change from Baseline

-0.301
10^12*cells/L (Mean)
Standard Deviation: 0.2694

100 mg BAY3427080

Baseline

4.459
10^12*cells/L (Mean)
Standard Deviation: 0.2962

Day 14 Change from Baseline

-0.511
10^12*cells/L (Mean)
Standard Deviation: 0.2111

150 mg BAY3427080

Baseline

4.365
10^12*cells/L (Mean)
Standard Deviation: 0.3678

Day 14 Change from Baseline

-0.485
10^12*cells/L (Mean)
Standard Deviation: 0.1903

300 mg BAY3427080

Baseline

4.518
10^12*cells/L (Mean)
Standard Deviation: 0.2368

Day 14 Change from Baseline

-0.425
10^12*cells/L (Mean)
Standard Deviation: 0.2297

Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes Mean Corpuscular Volume and Mean Platelet Volume.

Blood samples for the assessment of Erythrocytes Mean Corpuscular Volume and Mean Platelet Volume were collected upon participants admission to the unit.

Placebo

Baseline (Erythrocytes Mean Corpuscular Volume )

87.87
fL (Mean)
Standard Deviation: 5.707

Baseline (Mean Platelet Volume)

9.79
fL (Mean)
Standard Deviation: 0.809

Day 14 Change from Baseline (Erythrocytes Mean Corpuscular Volume )

0.44
fL (Mean)
Standard Deviation: 1.155

Day 14 Change from Baseline (Mean Platelet Volume)

-0.14
fL (Mean)
Standard Deviation: 0.448

50 mg BAY3427080

Baseline (Erythrocytes Mean Corpuscular Volume )

87.69
fL (Mean)
Standard Deviation: 3.890

Baseline (Mean Platelet Volume)

9.91
fL (Mean)
Standard Deviation: 1.608

Day 14 Change from Baseline (Erythrocytes Mean Corpuscular Volume )

0.11
fL (Mean)
Standard Deviation: 0.799

Day 14 Change from Baseline (Mean Platelet Volume)

0.08
fL (Mean)
Standard Deviation: 0.412

100 mg BAY3427080

Baseline (Erythrocytes Mean Corpuscular Volume )

87.71
fL (Mean)
Standard Deviation: 4.717

Baseline (Mean Platelet Volume)

10.22
fL (Mean)
Standard Deviation: 1.565

Day 14 Change from Baseline (Erythrocytes Mean Corpuscular Volume )

0.47
fL (Mean)
Standard Deviation: 0.967

Day 14 Change from Baseline (Mean Platelet Volume)

-0.24
fL (Mean)
Standard Deviation: 0.220

150 mg BAY3427080

Baseline (Erythrocytes Mean Corpuscular Volume )

89.42
fL (Mean)
Standard Deviation: 6.744

Baseline (Mean Platelet Volume)

10.19
fL (Mean)
Standard Deviation: 1.005

Day 14 Change from Baseline (Erythrocytes Mean Corpuscular Volume )

0.49
fL (Mean)
Standard Deviation: 1,691

Day 14 Change from Baseline (Mean Platelet Volume)

-0.37
fL (Mean)
Standard Deviation: 0.403

300 mg BAY3427080

Baseline (Erythrocytes Mean Corpuscular Volume )

88.63
fL (Mean)
Standard Deviation: 3.150

Baseline (Mean Platelet Volume)

10.05
fL (Mean)
Standard Deviation: 1.179

Day 14 Change from Baseline (Erythrocytes Mean Corpuscular Volume )

-0.27
fL (Mean)
Standard Deviation: 0.659

Day 14 Change from Baseline (Mean Platelet Volume)

-0.06
fL (Mean)
Standard Deviation: 0.216

Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes Mean Corpuscular Hemoglobin

Blood samples for the assessment of Erythrocytes Mean Corpuscular Hemoglobin were collected upon participants admission to the unit.

Placebo

Baseline

28.89
pg (Mean)
Standard Deviation: 2.517

Day 14 Change from Baseline

0.09
pg (Mean)
Standard Deviation: 0.494

50 mg BAY3427080

Baseline

29.5
pg (Mean)
Standard Deviation: 1.803

Day 14 Change from Baseline

-0.19
pg (Mean)
Standard Deviation: 0.263

100 mg BAY3427080

Baseline

28.79
pg (Mean)
Standard Deviation: 2.217

Day 14 Change from Baseline

0.03
pg (Mean)
Standard Deviation: 0.486

150 mg BAY3427080

Baseline

29.39
pg (Mean)
Standard Deviation: 2.511

Day 14 Change from Baseline

0.15
pg (Mean)
Standard Deviation: 0.532

300 mg BAY3427080

Baseline

28.89
pg (Mean)
Standard Deviation: 1.759

Day 14 Change from Baseline

0.17
pg (Mean)
Standard Deviation: 0.317

Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Erythrocytes Distribution Width.

Blood samples for the assessment of Erythrocytes Distribution Width were collected upon participants admission to the unit. Erythrocytes distribution width (in percentage) = 1 SD of Erythrocyte volume/MCV x 100%

Placebo

Baseline

27.81
Percentage of Erythrocyte volume (Mean)
Standard Deviation: 15.478

Day 14 Change from Baseline

-0.15
Percentage of Erythrocyte volume (Mean)
Standard Deviation: 0.916

50 mg BAY3427080

Baseline

25.52
Percentage of Erythrocyte volume (Mean)
Standard Deviation: 15.413

Day 14 Change from Baseline

0.49
Percentage of Erythrocyte volume (Mean)
Standard Deviation: 0.863

100 mg BAY3427080

Baseline

35.82
Percentage of Erythrocyte volume (Mean)
Standard Deviation: 16.476

Day 14 Change from Baseline

-0.05
Percentage of Erythrocyte volume (Mean)
Standard Deviation: 1.878

150 mg BAY3427080

Baseline

30.59
Percentage of Erythrocyte volume (Mean)
Standard Deviation: 16.089

Day 14 Change from Baseline

-0.61
Percentage of Erythrocyte volume (Mean)
Standard Deviation: 0.696

300 mg BAY3427080

Baseline

31.48
Percentage of Erythrocyte volume (Mean)
Standard Deviation: 17.013

Day 14 Change from Baseline

-0.68
Percentage of Erythrocyte volume (Mean)
Standard Deviation: 0.778

Change From Baseline at Day 14 for Laboratory Parameters HEMATOLOGY: Hematocrit.

Blood samples for the assessment of Hematocrit were collected upon participants admission to the unit.

Placebo

Baseline

39.18
Volume percentage (Mean)
Standard Deviation: 1.976

Day 14 Change from Baseline

-3.51
Volume percentage (Mean)
Standard Deviation: 1.307

50 mg BAY3427080

Baseline

39.63
Volume percentage (Mean)
Standard Deviation: 2.461

Day 14 Change from Baseline

-2.45
Volume percentage (Mean)
Standard Deviation: 2.106

100 mg BAY3427080

Baseline

38.99
Volume percentage (Mean)
Standard Deviation: 1.788

Day 14 Change from Baseline

-4.2
Volume percentage (Mean)
Standard Deviation: 1.877

150 mg BAY3427080

Baseline

38.85
Volume percentage (Mean)
Standard Deviation: 1.990

Day 14 Change from Baseline

-4.13
Volume percentage (Mean)
Standard Deviation: 1.431

300 mg BAY3427080

Baseline

40.02
Volume percentage (Mean)
Standard Deviation: 2.646

Day 14 Change from Baseline

-3.86
Volume percentage (Mean)
Standard Deviation: 2.163

Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Protein and Albumin.

Blood samples for the assessment of Protein and Albumin were collected upon participants admission to the unit.

Placebo

Baseline(Albumin)

42.9
g/L (Mean)
Standard Deviation: 6.75

Baseline (Protein)

71.8
g/L (Mean)
Standard Deviation: 4.54

Day 14 Change from Baseline (Albumin)

-0.6
g/L (Mean)
Standard Deviation: 6.42

Day 14 Change from Baseline(Protein)

-4.0
g/L (Mean)
Standard Deviation: 3.11

50 mg BAY3427080

Baseline(Albumin)

44.3
g/L (Mean)
Standard Deviation: 1.84

Baseline (Protein)

72.2
g/L (Mean)
Standard Deviation: 4.13

Day 14 Change from Baseline (Albumin)

-2.5
g/L (Mean)
Standard Deviation: 2.42

Day 14 Change from Baseline(Protein)

-2.5
g/L (Mean)
Standard Deviation: 4.39

100 mg BAY3427080

Baseline(Albumin)

44.4
g/L (Mean)
Standard Deviation: 2.53

Baseline (Protein)

74.3
g/L (Mean)
Standard Deviation: 4.25

Day 14 Change from Baseline (Albumin)

-3.2
g/L (Mean)
Standard Deviation: 2.08

Day 14 Change from Baseline(Protein)

-6.9
g/L (Mean)
Standard Deviation: 4.89

150 mg BAY3427080

Baseline(Albumin)

44.7
g/L (Mean)
Standard Deviation: 2.53

Baseline (Protein)

70.5
g/L (Mean)
Standard Deviation: 4.84

Day 14 Change from Baseline (Albumin)

0.3
g/L (Mean)
Standard Deviation: 2.05

Day 14 Change from Baseline(Protein)

-4.1
g/L (Mean)
Standard Deviation: 2.64

300 mg BAY3427080

Baseline(Albumin)

43.2
g/L (Mean)
Standard Deviation: 2.67

Baseline (Protein)

69.2
g/L (Mean)
Standard Deviation: 4.22

Day 14 Change from Baseline (Albumin)

-1.8
g/L (Mean)
Standard Deviation: 2.44

Day 14 Change from Baseline(Protein)

-2.5
g/L (Mean)
Standard Deviation: 3.10

Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Creatine Kinase

Blood samples for the assessment of Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Creatine Kinase were collected upon participants admission to the unit.

Placebo

Baseline(Alanine Aminotransferase)

0.295
ukat/L (Mean)
Standard Deviation: 0.1302

Baseline (Alkaline Phosphatase)

1.587
ukat/L (Mean)
Standard Deviation: 0.4829

Baseline (Aspartate Aminotransferase)

0.344
ukat/L (Mean)
Standard Deviation: 0.0760

Baseline (Creatine Kinase)

1.957
ukat/L (Mean)
Standard Deviation: 0.8872

Baseline (Gamma Glutamyl Transferase)

0.309
ukat/L (Mean)
Standard Deviation: 0.1740

Day 14 Change from Baseline (Alanine Aminotransferase)

0.108
ukat/L (Mean)
Standard Deviation: 0.4103

Day 14 Change from Baseline (Alkaline Phosphatase)

-0.129
ukat/L (Mean)
Standard Deviation: 0.3411

Day 14 Change from Baseline (Aspartate Aminotransferase)

0.041
ukat/L (Mean)
Standard Deviation: 0.2197

Day 14 Change from Baseline (Creatine Kinase)

0.021
ukat/L (Mean)
Standard Deviation: 0.9758

Day 14 Change from Baseline (Gamma Glutamyl Transferase)

0.101
ukat/L (Mean)
Standard Deviation: 0.3890

50 mg BAY3427080

Baseline(Alanine Aminotransferase)

0.331
ukat/L (Mean)
Standard Deviation: 0.1494

Baseline (Alkaline Phosphatase)

1.397
ukat/L (Mean)
Standard Deviation: 0.3233

Baseline (Aspartate Aminotransferase)

0.355
ukat/L (Mean)
Standard Deviation: 0.0632

Baseline (Creatine Kinase)

2.047
ukat/L (Mean)
Standard Deviation: 1.0146

Baseline (Gamma Glutamyl Transferase)

0.324
ukat/L (Mean)
Standard Deviation: 0.2085

Day 14 Change from Baseline (Alanine Aminotransferase)

-0.049
ukat/L (Mean)
Standard Deviation: 0.1053

Day 14 Change from Baseline (Alkaline Phosphatase)

-0.13
ukat/L (Mean)
Standard Deviation: 0.2054

Day 14 Change from Baseline (Aspartate Aminotransferase)

-0.035
ukat/L (Mean)
Standard Deviation: 0.0542

Day 14 Change from Baseline (Creatine Kinase)

-0.26
ukat/L (Mean)
Standard Deviation: 0.4338

Day 14 Change from Baseline (Gamma Glutamyl Transferase)

-0.035
ukat/L (Mean)
Standard Deviation: 0.0980

100 mg BAY3427080

Baseline(Alanine Aminotransferase)

0.279
ukat/L (Mean)
Standard Deviation: 0.1151

Baseline (Alkaline Phosphatase)

1.364
ukat/L (Mean)
Standard Deviation: 0.3219

Baseline (Aspartate Aminotransferase)

0.343
ukat/L (Mean)
Standard Deviation: 0.0950

Baseline (Creatine Kinase)

1.907
ukat/L (Mean)
Standard Deviation: 1.1933

Baseline (Gamma Glutamyl Transferase)

0.397
ukat/L (Mean)
Standard Deviation: 0.2111

Day 14 Change from Baseline (Alanine Aminotransferase)

0.049
ukat/L (Mean)
Standard Deviation: 0,2099

Day 14 Change from Baseline (Alkaline Phosphatase)

-0.172
ukat/L (Mean)
Standard Deviation: 0.1533

Day 14 Change from Baseline (Aspartate Aminotransferase)

-0.032
ukat/L (Mean)
Standard Deviation: 0.1030

Day 14 Change from Baseline (Creatine Kinase)

-0.252
ukat/L (Mean)
Standard Deviation: 0.5078

Day 14 Change from Baseline (Gamma Glutamyl Transferase)

0.001
ukat/L (Mean)
Standard Deviation: 0.1606

150 mg BAY3427080

Baseline(Alanine Aminotransferase)

0.313
ukat/L (Mean)
Standard Deviation: 0.1281

Baseline (Alkaline Phosphatase)

1.397
ukat/L (Mean)
Standard Deviation: 0.3271

Baseline (Aspartate Aminotransferase)

0.352
ukat/L (Mean)
Standard Deviation: 0.0737

Baseline (Creatine Kinase)

1.895
ukat/L (Mean)
Standard Deviation: 1.2638

Baseline (Gamma Glutamyl Transferase)

0.561
ukat/L (Mean)
Standard Deviation: 0.7998

Day 14 Change from Baseline (Alanine Aminotransferase)

-0.016
ukat/L (Mean)
Standard Deviation: 0.1391

Day 14 Change from Baseline (Alkaline Phosphatase)

-0.203
ukat/L (Mean)
Standard Deviation: 0.2576

Day 14 Change from Baseline (Aspartate Aminotransferase)

-0.009
ukat/L (Mean)
Standard Deviation: 0.0743

Day 14 Change from Baseline (Creatine Kinase)

-0.038
ukat/L (Mean)
Standard Deviation: 0.5689

Day 14 Change from Baseline (Gamma Glutamyl Transferase)

-0.19
ukat/L (Mean)
Standard Deviation: 0.4620

300 mg BAY3427080

Baseline(Alanine Aminotransferase)

0.413
ukat/L (Mean)
Standard Deviation: 0.1755

Baseline (Alkaline Phosphatase)

1.407
ukat/L (Mean)
Standard Deviation: 0.4417

Baseline (Aspartate Aminotransferase)

0.401
ukat/L (Mean)
Standard Deviation: 0.1976

Baseline (Creatine Kinase)

1.886
ukat/L (Mean)
Standard Deviation: 1.1854

Baseline (Gamma Glutamyl Transferase)

0.372
ukat/L (Mean)
Standard Deviation: 0.2272

Day 14 Change from Baseline (Alanine Aminotransferase)

0.052
ukat/L (Mean)
Standard Deviation: 0.3923

Day 14 Change from Baseline (Alkaline Phosphatase)

-0.131
ukat/L (Mean)
Standard Deviation: 0.2958

Day 14 Change from Baseline (Aspartate Aminotransferase)

-0.032
ukat/L (Mean)
Standard Deviation: 0.2851

Day 14 Change from Baseline (Creatine Kinase)

-0.269
ukat/L (Mean)
Standard Deviation: 0.5032

Day 14 Change from Baseline (Gamma Glutamyl Transferase)

0.015
ukat/L (Mean)
Standard Deviation: 0.1959

Change From Baseline at Day 14 for Laboratory Parameters CHEMISTRY: Urate, Bilirubin and Creatinine.

Blood samples for the assessment of Urate, Bilirubin and Creatinine were collected upon participants admission to the unit.

Placebo

Baseline (Bilirubin)

7.61
umol/L (Mean)
Standard Deviation: 3.500

Baseline(Creatinine)

71.162
umol/L (Mean)
Standard Deviation: 11.3215

Baseline (Urate)

297.43
umol/L (Mean)
Standard Deviation: 41.896

Day 14 Change from Baseline(Bilirubin)

-1.25
umol/L (Mean)
Standard Deviation: 3.225

Day 14 Change from Baseline(Creatinine)

2.652
umol/L (Mean)
Standard Deviation: 6.4810

Day 14 Change from Baseline (Urate)

-11.9
umol/L (Mean)
Standard Deviation: 41.380

50 mg BAY3427080

Baseline (Bilirubin)

8.44
umol/L (Mean)
Standard Deviation: 3.640

Baseline(Creatinine)

67.125
umol/L (Mean)
Standard Deviation: 8.0711

Baseline (Urate)

318.23
umol/L (Mean)
Standard Deviation: 20.323

Day 14 Change from Baseline(Bilirubin)

-1.15
umol/L (Mean)
Standard Deviation: 2.654

Day 14 Change from Baseline(Creatinine)

-1.885
umol/L (Mean)
Standard Deviation: 7.8090

Day 14 Change from Baseline (Urate)

-2.95
umol/L (Mean)
Standard Deviation: 28.511

100 mg BAY3427080

Baseline (Bilirubin)

7.19
umol/L (Mean)
Standard Deviation: 2.932

Baseline(Creatinine)

65.121
umol/L (Mean)
Standard Deviation: 9.8867

Baseline (Urate)

261.74
umol/L (Mean)
Standard Deviation: 57.222

Day 14 Change from Baseline(Bilirubin)

-1.0
umol/L (Mean)
Standard Deviation: 1.886

Day 14 Change from Baseline(Creatinine)

-4.168
umol/L (Mean)
Standard Deviation: 7.6761

Day 14 Change from Baseline (Urate)

2.57
umol/L (Mean)
Standard Deviation: 19.706

150 mg BAY3427080

Baseline (Bilirubin)

6.96
umol/L (Mean)
Standard Deviation: 2.652

Baseline(Creatinine)

67.891
umol/L (Mean)
Standard Deviation: 9.1636

Baseline (Urate)

275.34
umol/L (Mean)
Standard Deviation: 75.528

Day 14 Change from Baseline(Bilirubin)

-0.01
umol/L (Mean)
Standard Deviation: 2.599

Day 14 Change from Baseline(Creatinine)

-1.297
umol/L (Mean)
Standard Deviation: 6.6136

Day 14 Change from Baseline (Urate)

-12.76
umol/L (Mean)
Standard Deviation: 28.636

300 mg BAY3427080

Baseline (Bilirubin)

7.23
umol/L (Mean)
Standard Deviation: 3.305

Baseline(Creatinine)

11.844
umol/L (Mean)
Standard Deviation: 8.9096

Baseline (Urate)

212.17
umol/L (Mean)
Standard Deviation: 52.885

Day 14 Change from Baseline(Bilirubin)

0.4
umol/L (Mean)
Standard Deviation: 3.069

Day 14 Change from Baseline(Creatinine)

-3.605
umol/L (Mean)
Standard Deviation: 5.6665

Day 14 Change from Baseline (Urate)

-7.93
umol/L (Mean)
Standard Deviation: 44.269

Change From Baseline at Day 14 for Clinical Laboratory Parameters CHEMISTRY: Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen.

Blood samples for the assessment of Sodium, Potassium, Chloride, Bicarbonate, Calcium, Phosphate, Glucose, Magnesium and Urea Nitrogen were collected upon participant's admission to the unit.

Placebo

Baseline (Bicarbonate)

26.39
mmol/L (Mean)
Standard Deviation: 2.615

Baseline (Calcium)

2.421
mmol/L (Mean)
Standard Deviation: 0.0803

Baseline (Chloride)

102.8
mmol/L (Mean)
Standard Deviation: 2.94

Baseline (Glucose)

5.457
mmol/L (Mean)
Standard Deviation: 0.6417

Baseline (Magnesium)

0.893
mmol/L (Mean)
Standard Deviation: 0.0732

Baseline (Phosphate)

1.24
mmol/L (Mean)
Standard Deviation: 0.1510

Baseline (Potassium)

4.41
mmol/L (Mean)
Standard Deviation: 0.375

Baseline (Sodium)

140.7
mmol/L (Mean)
Standard Deviation: 2.93

Baseline (Urea Nitrogen)

5.59
mmol/L (Mean)
Standard Deviation: 1.230

Day 14 Change from Baseline (Bicarbonate)

1.11
mmol/L (Mean)
Standard Deviation: 3.660

Day 14 Change from Baseline (Calcium)

-0.032
mmol/L (Mean)
Standard Deviation: 0.1198

Day 14 Change from Baseline ( Chloride)

-1.2
mmol/L (Mean)
Standard Deviation: 3.20

Day 14 Change from Baseline (Glucose)

-0.113
mmol/L (Mean)
Standard Deviation: 0.9083

Day 14 Change from Baseline (Magnesium)

-0.009
mmol/L (Mean)
Standard Deviation: 0.0460

Day 14 Change from Baseline (Phosphate)

0.026
mmol/L (Mean)
Standard Deviation: 0.1602

Day 14 Change from Baseline (Potassium)

0.06
mmol/L (Mean)
Standard Deviation: 0.478

Day 14 Change from Baseline (Sodium)

-0.9
mmol/L (Mean)
Standard Deviation: 2.91

Day 14 Change from Baseline (Urea Nitrogen)

0.14
mmol/L (Mean)
Standard Deviation: 2.359

50 mg BAY3427080

Baseline (Bicarbonate)

26.6
mmol/L (Mean)
Standard Deviation: 2.131

Baseline (Calcium)

2.401
mmol/L (Mean)
Standard Deviation: 0.0730

Baseline (Chloride)

102.4
mmol/L (Mean)
Standard Deviation: 3.79

Baseline (Glucose)

5.521
mmol/L (Mean)
Standard Deviation: 0.4157

Baseline (Magnesium)

0.885
mmol/L (Mean)
Standard Deviation: 0.0588

Baseline (Phosphate)

1.249
mmol/L (Mean)
Standard Deviation: 0.1277

Baseline (Potassium)

4.22
mmol/L (Mean)
Standard Deviation: 0.246

Baseline (Sodium)

140.3
mmol/L (Mean)
Standard Deviation: 2.05

Baseline (Urea Nitrogen)

5.47
mmol/L (Mean)
Standard Deviation: 1.337

Day 14 Change from Baseline (Bicarbonate)

-0.93
mmol/L (Mean)
Standard Deviation: 3.575

Day 14 Change from Baseline (Calcium)

-0.044
mmol/L (Mean)
Standard Deviation: 0.1355

Day 14 Change from Baseline ( Chloride)

0.4
mmol/L (Mean)
Standard Deviation: 3.16

Day 14 Change from Baseline (Glucose)

-0.278
mmol/L (Mean)
Standard Deviation: 0.4006

Day 14 Change from Baseline (Magnesium)

0.001
mmol/L (Mean)
Standard Deviation: 0.0387

Day 14 Change from Baseline (Phosphate)

-0.045
mmol/L (Mean)
Standard Deviation: 0.1457

Day 14 Change from Baseline (Potassium)

0.22
mmol/L (Mean)
Standard Deviation: 0.323

Day 14 Change from Baseline (Sodium)

-0.7
mmol/L (Mean)
Standard Deviation: 2.97

Day 14 Change from Baseline (Urea Nitrogen)

-0.14
mmol/L (Mean)
Standard Deviation: 1.070

100 mg BAY3427080

Baseline (Bicarbonate)

27.47
mmol/L (Mean)
Standard Deviation: 1.642

Baseline (Calcium)

2.515
mmol/L (Mean)
Standard Deviation: 0.0998

Baseline (Chloride)

100.7
mmol/L (Mean)
Standard Deviation: 2.32

Baseline (Glucose)

5.349
mmol/L (Mean)
Standard Deviation: 0.4957

Baseline (Magnesium)

0.881
mmol/L (Mean)
Standard Deviation: 0.0675

Baseline (Phosphate)

1.268
mmol/L (Mean)
Standard Deviation: 0.1269

Baseline (Potassium)

4.29
mmol/L (Mean)
Standard Deviation: 0.374

Baseline (Sodium)

140.0
mmol/L (Mean)
Standard Deviation: 1.65

Baseline (Urea Nitrogen)

4.67
mmol/L (Mean)
Standard Deviation: 1.274

Day 14 Change from Baseline (Bicarbonate)

1.0
mmol/L (Mean)
Standard Deviation: 3.088

Day 14 Change from Baseline (Calcium)

-0.144
mmol/L (Mean)
Standard Deviation: 0.1147

Day 14 Change from Baseline ( Chloride)

1.1
mmol/L (Mean)
Standard Deviation: 1.69

Day 14 Change from Baseline (Glucose)

-0.173
mmol/L (Mean)
Standard Deviation: 0.3412

Day 14 Change from Baseline (Magnesium)

0.001
mmol/L (Mean)
Standard Deviation: 0.0529

Day 14 Change from Baseline (Phosphate)

-0.052
mmol/L (Mean)
Standard Deviation: 0.1096

Day 14 Change from Baseline (Potassium)

0.15
mmol/L (Mean)
Standard Deviation: 0.427

Day 14 Change from Baseline (Sodium)

-0.5
mmol/L (Mean)
Standard Deviation: 2.28

Day 14 Change from Baseline (Urea Nitrogen)

0.2
mmol/L (Mean)
Standard Deviation: 0.826

150 mg BAY3427080

Baseline (Bicarbonate)

26.2
mmol/L (Mean)
Standard Deviation: 1.699

Baseline (Calcium)

2.411
mmol/L (Mean)
Standard Deviation: 0.0622

Baseline (Chloride)

102.7
mmol/L (Mean)
Standard Deviation: 2.84

Baseline (Glucose)

5.483
mmol/L (Mean)
Standard Deviation: 0.3943

Baseline (Magnesium)

0.905
mmol/L (Mean)
Standard Deviation: 0.0703

Baseline (Phosphate)

1.28
mmol/L (Mean)
Standard Deviation: 0.1115

Baseline (Potassium)

4.49
mmol/L (Mean)
Standard Deviation: 0.380

Baseline (Sodium)

142.3
mmol/L (Mean)
Standard Deviation: 3.01

Baseline (Urea Nitrogen)

5.3
mmol/L (Mean)
Standard Deviation: 1.198

Day 14 Change from Baseline (Bicarbonate)

2.0
mmol/L (Mean)
Standard Deviation: 2.204

Day 14 Change from Baseline (Calcium)

-0.049
mmol/L (Mean)
Standard Deviation: 0.0630

Day 14 Change from Baseline ( Chloride)

-1.1
mmol/L (Mean)
Standard Deviation: 3.02

Day 14 Change from Baseline (Glucose)

-0.098
mmol/L (Mean)
Standard Deviation: 0.4245

Day 14 Change from Baseline (Magnesium)

0.006
mmol/L (Mean)
Standard Deviation: 0.0484

Day 14 Change from Baseline (Phosphate)

0.027
mmol/L (Mean)
Standard Deviation: 0.1389

Day 14 Change from Baseline (Potassium)

-0.06
mmol/L (Mean)
Standard Deviation: 0.408

Day 14 Change from Baseline (Sodium)

-2.5
mmol/L (Mean)
Standard Deviation: 3.23

Day 14 Change from Baseline (Urea Nitrogen)

300 mg BAY3427080

Baseline (Bicarbonate)

27.62
mmol/L (Mean)
Standard Deviation: 3.641

Baseline (Calcium)

2.382
mmol/L (Mean)
Standard Deviation: 0.0928

Baseline (Chloride)

101.4
mmol/L (Mean)
Standard Deviation: 1.56

Baseline (Glucose)

5.456
mmol/L (Mean)
Standard Deviation: 0.4401

Baseline (Magnesium)

0.896
mmol/L (Mean)
Standard Deviation: 0.0836

Baseline (Phosphate)

1.272
mmol/L (Mean)
Standard Deviation: 0.1544

Baseline (Potassium)

4.14
mmol/L (Mean)
Standard Deviation: 0.421

Baseline (Sodium)

140.0
mmol/L (Mean)
Standard Deviation: 2.83

Baseline (Urea Nitrogen)

5.21
mmol/L (Mean)
Standard Deviation: 1.393

Day 14 Change from Baseline (Bicarbonate)

0.31
mmol/L (Mean)
Standard Deviation: 2.626

Day 14 Change from Baseline (Calcium)

-0.052
mmol/L (Mean)
Standard Deviation: 0.1103

Day 14 Change from Baseline ( Chloride)

0.8
mmol/L (Mean)
Standard Deviation: 2.88

Day 14 Change from Baseline (Glucose)

0.025
mmol/L (Mean)
Standard Deviation: 0.3063

Day 14 Change from Baseline (Magnesium)

-0.027
mmol/L (Mean)
Standard Deviation: 0.0696

Day 14 Change from Baseline (Phosphate)

-0.038
mmol/L (Mean)
Standard Deviation: 0.2171

Day 14 Change from Baseline (Potassium)

0.31
mmol/L (Mean)
Standard Deviation: 0.614

Day 14 Change from Baseline (Sodium)

0.7
mmol/L (Mean)
Standard Deviation: 3.47

Day 14 Change from Baseline (Urea Nitrogen)

-0.38
mmol/L (Mean)
Standard Deviation: 1.488

Laboratory Parameters CHEMISTRY: Glomerular Filtration Rate African at Baseline

Blood samples for the assessment of Glomerular Filtration Rate African were collected upon participants admission to the unit.

Placebo

1.628
mL/sec/1.73m^2 (Mean)
Standard Deviation: 0.2347

50 mg BAY3427080

1.759
mL/sec/1.73m^2 (Mean)
Standard Deviation: 0.1592

100 mg BAY3427080

1.58
mL/sec/1.73m^2 (Mean)
Standard Deviation: 0.1846

150 mg BAY3427080

1.557
mL/sec/1.73m^2 (Mean)
Standard Deviation: 0.1553

300 mg BAY3427080

1.666
mL/sec/1.73m^2 (Mean)
Standard Deviation: 0.1885

Laboratory Parameters CHEMISTRY: Glomerular Filtration Rate Caucasian at Baseline

Blood samples for the assessment of Glomerular Filtration Rate Caucasian were collected upon participants admission to the unit.

Placebo

1.343
mL/sec/1.73m^2 (Mean)
Standard Deviation: 0.1955

50 mg BAY3427080

1.45
mL/sec/1.73m^2 (Mean)
Standard Deviation: 0.1265

100 mg BAY3427080

1.3
mL/sec/1.73m^2 (Mean)
Standard Deviation: 0.1503

150 mg BAY3427080

1.29
mL/sec/1.73m^2 (Mean)
Standard Deviation: 0.1273

300 mg BAY3427080

1.378
mL/sec/1.73m^2 (Mean)
Standard Deviation: 0.1482

Change From Baseline at Day 14 for COAGULATION: Prothrombin International Normalized Ratio (INR)

Blood samples for the assessment of Prothrombin International Normalized Ratio were collected upon participants admission to the unit.

Placebo

Baseline

0.993
INR (Mean)
Standard Deviation: 0.0428

Day 14 Change from Baseline

-0.007
INR (Mean)
Standard Deviation: 0.0546

50 mg BAY3427080

Baseline

1.013
INR (Mean)
Standard Deviation: 0.0552

Day 14 Change from Baseline

-0.038
INR (Mean)
Standard Deviation: 0.0471

100 mg BAY3427080

Baseline

1.007
INR (Mean)
Standard Deviation: 0.0482

Day 14 Change from Baseline

0.016
INR (Mean)
Standard Deviation: 0.0665

150 mg BAY3427080

Baseline

0.991
INR (Mean)
Standard Deviation: 0.0465

Day 14 Change from Baseline

0.013
INR (Mean)
Standard Deviation: 0.0359

300 mg BAY3427080

Baseline

0.993
INR (Mean)
Standard Deviation: 0.0645

Day 14 Change from Baseline

0.057
INR (Mean)
Standard Deviation: 0.2311

Change From Baseline at Day 14 for COAGULATION: Prothrombin Time and Activated Partial Thromboplastin Time

Blood samples for the assessment of Prothrombin Time and Activated Partial Thromboplastin Time were collected upon participants admission to the unit.

Placebo

Baseline(Activated Partial Thromboplastin Time)

26.91
sec (Mean)
Standard Deviation: 2.435

Baseline (Prothrombin Time )

11.17
sec (Mean)
Standard Deviation: 1.871

Day 14 Change from Baseline (Activated Partial Thromboplastin Time)

-0.82
sec (Mean)
Standard Deviation: 1.350

Day 14 Change from Baseline (Prothrombin Time)

-0.15
sec (Mean)
Standard Deviation: 0.507

50 mg BAY3427080

Baseline(Activated Partial Thromboplastin Time)

27.09
sec (Mean)
Standard Deviation: 2.495

Baseline (Prothrombin Time )

11.05
sec (Mean)
Standard Deviation: 1.679

Day 14 Change from Baseline (Activated Partial Thromboplastin Time)

-1.8
sec (Mean)
Standard Deviation: 1.489

Day 14 Change from Baseline (Prothrombin Time)

-0.32
sec (Mean)
Standard Deviation: 0.351

100 mg BAY3427080

Baseline(Activated Partial Thromboplastin Time)

28.14
sec (Mean)
Standard Deviation: 2.483

Baseline (Prothrombin Time )

11.91
sec (Mean)
Standard Deviation: 1.871

Day 14 Change from Baseline (Activated Partial Thromboplastin Time)

-0.81
sec (Mean)
Standard Deviation: 1.478

Day 14 Change from Baseline (Prothrombin Time)

0.12
sec (Mean)
Standard Deviation: 0.503

150 mg BAY3427080

Baseline(Activated Partial Thromboplastin Time)

27.5
sec (Mean)
Standard Deviation: 2.872

Baseline (Prothrombin Time )

11.51
sec (Mean)
Standard Deviation: 1.757

Day 14 Change from Baseline (Activated Partial Thromboplastin Time)

-0.87
sec (Mean)
Standard Deviation: 1.396

Day 14 Change from Baseline (Prothrombin Time)

0.11
sec (Mean)
Standard Deviation: 0.291

300 mg BAY3427080

Baseline(Activated Partial Thromboplastin Time)

27.55
sec (Mean)
Standard Deviation: 3.009

Baseline (Prothrombin Time )

11.47
sec (Mean)
Standard Deviation: 1.589

Day 14 Change from Baseline (Activated Partial Thromboplastin Time)

0.58
sec (Mean)
Standard Deviation: 3.196

Day 14 Change from Baseline (Prothrombin Time)

0.55
sec (Mean)
Standard Deviation: 2.363

Heart Rate (HR) - Change From Baseline (Day -1) at Day 14

Heart rate was measured as part of the 12-lead electrocardiogram. Resting ECG recordings were made.Holter monitors were fitted to participants upon admission in clinic on Day -1 and Day 14.

Placebo