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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Hepatic Insufficiency

Treatments: Drug: BMS-650032

Study type: Interventional

Funder types: Industry

Identifiers

NCT01019070

AI447-012

Details and patient eligibility

About

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

Enrollment: 28 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

28 participants in 4 patient groups

BMS-650032 in Child-Pugh A

Active Comparator group

Treatment:

Drug: BMS-650032

BMS-650032 in Child-Pugh B

Active Comparator group

Treatment:

Drug: BMS-650032

BMS-650032 in Child-Pugh C

Active Comparator group

Treatment:

Drug: BMS-650032

BMS-650032 in Healthy Subjects

Active Comparator group

Treatment:

Drug: BMS-650032