Title

A Study of Multiple Oral Doses of IX-01 in Healthy Men
A Double-blind, Randomised, Placebo-controlled, Parallel Group, Dose Escalation Study to Investigate the Safety, Tolerability and Pharmacokinetics of Multiple Oral Doses of IX-01 in Healthy Male Subjects
  • Phase

    Phase 1
  • Study Type

    Interventional
  • Status

    Completed No Results Posted
  • Intervention/Treatment

    ix-01 ...
  • Study Participants

    48
The purpose of this study is to investigate the safety and tolerability of IX-01 after multiple doses, and to determine how the body handles IX-01.
Study Started
Nov 30
2013
Primary Completion
Mar 31
2014
Study Completion
Mar 31
2014
Last Update
Sep 03
2014
Estimate

Drug Placebo

Administered orally

Drug IX-01

Administered orally

Placebo Placebo Comparator

Placebo

IX-01 Experimental

Up to 4 different dose groups within 50 to 1,200 mg of IX-01 oral aqueous dispersion, administered once daily for 10 days

Criteria

Inclusion Criteria:

A body mass index (Quetelet index) in the range 18-30
Total body weight greater than (>)50 kilograms (kg) at screening
Able to understand the nature of the trial and any hazards of participating in it
Able to communicate satisfactorily with the investigator and to participate in, and comply with the requirements of, the entire trial
Participants and their partners must be willing to use adequate forms of contraception and comply with contraception requirements during the trial, and for 4 months after the last dose of medication
Must not plan to donate sperm or father a child during the trial, and for 4 months after the final dose of medication

Exclusion Criteria:

Clinically relevant abnormal history, physical findings, electrocardiogram (ECG), or laboratory values at the screening assessment that could interfere with the objectives of the trial or the safety of the participant
Presence of acute or chronic illness or history of chronic illness sufficient to invalidate participation in the trial or make it unnecessarily hazardous
Impaired gastrointestinal, endocrine, thyroid, hepatic, cardiovascular, respiratory, haematological, renal or neurological function, diabetes mellitus, coronary heart disease, or history of any psychotic mental illness
Surgery (for example (e.g.) stomach bypass) or medical condition that might affect absorption, metabolism or elimination of medicines
Presence or history of severe adverse reaction to any drug
Use of any prescription or over-the-counter medicine during the 14 days before the first dose of trial medication, or intention to use any medicine during the trial, with the exception of short courses of medication considered by the investigator not to interfere with the safety of the participant or the integrity of the trial data (such as acetaminophen (paracetamol))
Current use of any herbal remedy or nutritional supplement, or intention to use any such product during the study
Participation in another clinical trial of a new chemical entity or a prescription medicine within the previous 3 months
Previous participation in this trial or any other clinical trial of an oxytocin receptor antagonist
Presence or history of drug or alcohol abuse, or intake of more than 21 units of alcohol weekly or more than 5 cigarettes daily
Blood pressure and heart rate in supine position at the screening examination outside the ranges 90-130 millimeters of mercury (mm Hg) systolic, 50-90 mm Hg diastolic; heart rate 50-90 beats/minute
Possibility that the participant will not cooperate with the requirements of the protocol
Evidence of drug abuse on urine testing
Positive test for hepatitis B, hepatitis C, Human Immunodeficiency Virus 1(HIV1) or Human Immunodeficiency Virus 2 (HIV2)
Loss of more than 400 milliliters (mL) blood during the 3 months before the trial, e.g. as a blood donor
Objection by General Practitioner (GP), on medical grounds, to participant entering trial
No Results Posted