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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Hepatic Insufficiency

Treatments: Drug: BMS-790052

Study type: Interventional

Funder types: Industry

Identifiers

NCT00859053

AI444-013

Details and patient eligibility

About

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

Enrollment: 46 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

46 participants in 4 patient groups

BMS-790052 in Child-Pugh A

Active Comparator group

Treatment:

Drug: BMS-790052

BMS-790052 in Child-Pugh B

Active Comparator group

Treatment:

Drug: BMS-790052

BMS-790052 in Child-Pugh C

Active Comparator group

Treatment:

Drug: BMS-790052

BMS-790052 in Healthy Subjects

Active Comparator group

Treatment:

Drug: BMS-790052