A Study of CDI-31244: A Novel NNI in HV and HCV Infected Subjects

• Status: Completed
• Trial end date: 2017-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a First in Human study of orally administered CDI-31244, a non-nucleoside inhibitor (NNI) in healthy volunteers and HCV infected individuals

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Cocrystal Pharma, Inc.

Criteria

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.