A Multiple Ascending Dose Study of BMS-650032 in HCV Infected Subjects

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary purpose of this study is to assess the change in HCV RNA during dosing with BMS-650032 and during the follow-up period in subjects with chronic hepatitis C infection

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

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Asunaprevir

Criteria

Inclusion Criteria:

• Chronically infected with HCV genotype 1

• Treatment naive

• HCV RNA viral load of ≥10*5 IU/mL

• BMI 18 to 35kg/m²

Exclusion Criteria:

• Women of childbearing potential (WOCBP)

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

• HCV infected subjects who are treatment non-responder (defined as subject who received at least 12 weeks of SOC and continue to have a detectable HCV RNA level or subjects who did not attain a 2-log decline in HCV RNA levels at 12 weeks and stopped treatment

• HCV infected subjects who are treatment intolerant (defined as subject who are unable to receive at least 12 weeks of SOC due to toxicities associated with interferon and/or ribavirin

• HIV and/or HBV positive

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