Study to Assess Safety,Tolerability,Pharmacokinetics & Antiviral Activity of JTK-853 in Hepatitis C Virus Genotype 1 Infected Subjects

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study was to determine the safety, tolerability, pharmacokinetics and anti-viral activity of JTK-853 in hepatitis C virus genotype 1 infected subjects based on reduction in viral load (HCV RNA level) from baseline to end of treatment, followed by genotypic resistance monitoring for up to one year after study drug treatment.

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

Details

• Lead Sponsor: Akros Pharma Inc.
• Treatments: Antiviral Agents

Criteria

Inclusion Criteria:

1. Males and females infected with chronic hepatitis C virus (HCV) infection and genotype 1a or 1b

2. Subjects with a viral load (HCV RNA level) of ≥50,000 IU/mL

3. Subjects with a body mass index (BMI) of 18.0-36.0 kg/m2 (inclusive)

Exclusion Criteria:

1. Subjects should not have previously received a direct acting anti-HCV agent

2. Subjects should not previously have received pegylated interferon/ribavirin for a duration of more than two weeks