Double-Blind, Dose-Escalation Study of IDX184 in Chronic Hepatitis C Treatment-Naïve Subjects

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a proof-of-concept study which will provide data about the safety and antiviral activity of several doses of the investigational drug IDX184 given for 3 days in treatment-naive HCV genotype 1-infected subjects so that optimal doses can be chosen for testing in later studies.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.

Criteria

Inclusion criteria:

1. 18-65 years old

2. Subject of childbearing potential must agree to use a consistent form of an acceptable double-barrier method of birth control.

3. Plasma HCV RNA ≥ 5 log10 IU/mL

4. HCV genotype 1

Exclusion criteria:

1. Received prior antiviral treatment for hepatitis C infection

2. Subject is pregnant or breastfeeding

3. Body Mass Index (BMI) > 32

4. Currently abusing alcohol or illicit drugs

5. Currently receiving methadone, buprenorphine or other drugs for the treatment of opioid addiction

6. Co-infected with hepatitis B virus (HBV, HBsAg positive) and/or human immunodeficiency virus (HIV)