Hepatic Impaired Subjects Compared to Healthy Subjects Receiving Multi-dose BMS-650032

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the effects of hepatic impairment on the multiple dose pharmacokinetics of BMS-650032.

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

Details

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

Criteria

Inclusion Criteria:

• Male and female subjects aged 18 to 70, with hepatic impairment conforming to Child-Pugh class A,B or C

• Each matched control subjects determined to be healthy

Exclusion Criteria:

• History of esophageal and gastric bleeding within the past 6 months

• Primarily cholestatic liver disease

• Active alcoholic hepatitis

• Stable encephalopathy of ≥Stage 2

• Presence of severe ascites or edema

• Presence of hepatopulmonary or hepatorenal syndrome

• Positive for HIV

• Positive for HCV, unless HCV RNA is undetectable