Title
A Study of CDI-31244: A Novel NNI in HV and HCV Infected Subjects
A Phase Ia/Ib Study Assessing Single and Multiple Doses of CDI-31244: A Non-Nucleoside Inhibitor in Healthy and Hepatitis C Virus-Infected Subjects
Phase
Phase 1Lead Sponsor
Cocrystal Pharma, Inc.Study Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Hepatitis CIntervention/Treatment
cdi-31244 ...Study Participants
76This is a First in Human study of orally administered CDI-31244, a non-nucleoside inhibitor (NNI) in healthy volunteers and HCV infected individuals
This is a single center, double-blind, placebo-controlled, randomized, single ascending oral dose and multiple oral dose design, incorporating fed/fasted comparisons.
The study will include two groups: Group A - single ascending dose (SAD) including a food effect cohort, and multiple dose (MD) in healthy volunteers (HV), and Group B MD in Hepatitis C Virus (HCV) infected individuals divided in two parts.
Five single-dose cohort are planned. For the five single-dose cohorts, a sentinel group of 2 subjects will be dosed at least one day prior to enrolling remaining subjects.
Six multiple-dose cohorts are planned. Three multiple dose cohorts in healthy volunteers and three cohorts in HCV-infected individuals.
The dosing of Group B will be conducted following safety and pharmacokinetic (PK) review of Group A. The dosing of Group B, Part 2 will be conducted only if Part 1 shows acceptable safety and efficacy results.
NNI
no active ingredients
CDI-31244 20 mg active or placebo single dose (SD)
CDI-31244 200 mg active or placebo SD; food effect
CDI-31244 200 mg active or placebo multiple dose (MD)
CDI-31244 400 mg active or placebo MD
Main Inclusion Criteria: HV and HCV INFECTED SUBJECTS: Male or female aged ≥ 18 to ≤ 65 years; Body mass index ≥ 18.5 to ≤ 35.0 kg/m2; Body weight ≥ 50 kg; Negative screening for alcohol and drugs of abuse; Normal results on 12-lead electrocardiogram (ECG); For females, negative result on a pregnancy test. HCV INFECTED SUBJECTS: HCV treatment-naïve subjects must have not received prior direct acting agent (DAA) treatment for hepatitis C infection; Documented clinical history compatible with chronic hepatitis C; HCV Genotype 1 by HCV genotyping performed at Screening; Plasma HCV RNA ≥ 5.0 log10 IU/mL at Screening; Laboratory evidence of no cirrhosis (negative liver biopsy or fibroscan or FibroTest, F2 or lower) within one year prior to study), if these are not available, do a FibroTest at screening, which must be F2 or lower. Main Exclusion Criteria: HV and HCV INFECTED SUBJECTS: Females who are pregnant or are lactating; Co-infected with hepatitis B virus (HBV, HBsAg positive) and/or human immunodeficiency virus (HIV); Abuse of alcohol and/or drugs that could interfere with adherence to study requirements as judged by the investigator; Positive screen result for drugs of abuse or alcohol on Day -1. Use of other investigational drugs within 60 days of dosing; Subject with intestinal malabsorption; Presence of out-of-range cardiac interval on the screening ECG or other clinically significant ECG abnormalities; Serum creatinine > upper limit of normal (ULN); Any clinically significant medical condition that, in the opinion of the investigator, would jeopardize the safety of the subject or impact the validity of the study results. HEALTHY VOLUNTEERS: Positive screen for anti-HCV antibody HCV INFECTED SUBJECTS: Clinical (in the opinion of the investigator) or laboratory evidence of cirrhosis; History or signs of decompensated liver disease: ascites, variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis, or other clinical signs of portal hypertension or hepatic insufficiency; History of hepatocellular carcinoma (HCC) or findings suggestive of possible HCC; Active clinically significant diseases.
