Single-Dose Pharmacokinetics of BMS-790052 in Participants With Hepatic Impairment

• Status: Completed
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the effects of hepatic impairment on the single dose pharmacokinetics of BMS-790052.

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

Details

• Lead Sponsor: Bristol-Myers Squibb

Criteria

Key Inclusion Criteria:

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

• Healthy subjects to the extent possible matched to the first four hepatically impaired subject in each Child-Pugh class with regard to age (approximately ± 10 years), body weight (approximately ± 20%) and gender

Key Exclusion Criteria:

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

• Primarily cholestatic liver diseases

• Active alcoholic hepatitis

• Stable encephalopathy of >= Stage 2

• Presence of severe ascites or edema

• Presence of hepatopulmonary or hepatorenal syndrome

• Positive for HCV, unless HCV RNA is undetectable