A Single Ascending Dose Study of Daclatasvir (BMS-790052) in Hepatitis C Virus Infected Subjects

• Status: Completed
• Trial end date: 2008-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary purpose of this study is to evaluate the safety profile and tolerability of single oral doses of daclatasvir in subjects with chronic hepatitis C infection

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

Details

• Lead Sponsor: Bristol-Myers Squibb

Criteria

Key Inclusion Criteria:

• Chronically infected with hepatitis C virus genotype 1

• Treatment naive or treatment non-responders or treatment intolerant; and not co-infected with HIV or hepatitis B virus

• Hepatitis C virus RNA viral load of ≥ 10*5* IU/mL

• BMI 18 to 35 kg/m²

Key Exclusion Criteria:

• Any significant acute or chronic medical illness which is not stable or is not controlled with medication and not consistent with hepatitis C virus infection

• Major surgery within 4 weeks of study drug administration and any gastrointestinal surgery that could impact the absorption of study drug