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

Phase 1CompletedNCT01019070

Bristol-Myers Squibb28 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Masking

NONE

Enrollment

Conditions

Hepatic Insufficiency

Interventions

BMS-650032DRUG

Capsules, Oral, 200 mg, BID, 7 Days

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Advanced Clinical Res Inst

Anaheim, California, United States

Orlando Clinical Research Center

Orlando, Florida, United States

Outcomes

Primary Outcomes

Pharmacokinetics parameters including Cmax, Tmax,AUC(TAU),Vss/F, T-Half, CLT/F and AI

Time frame: Day 10

Secondary Outcomes

Assess the safety and tolerability of BMS-650032 in subjects with hepatic impairment and in healthy subjects. This will be measured by: blood chemistries, hematology, urinalysis and ECGs

Time frame: Day 10

Assess the relationship between the Child-Pugh classification (including its components) and BMS-650032 PK parameters. This will be measured by frequent pharmacokinetics blood samples.

Time frame: Day 10

Data from ClinicalTrials.gov

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