Hepatic Insufficiency
Conditions
Brief summary
The purpose of this study is to assess the effects of hepatic impairment on the multiple dose pharmacokinetics of BMS-650032.
Interventions
DRUGBMS-650032
Capsules, Oral, 200 mg, BID, 7 Days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics parameters including Cmax, Tmax,AUC(TAU),Vss/F, T-Half, CLT/F and AI | Day 10 |
Secondary
| Measure | Time frame |
|---|---|
| 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 | 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. | Day 10 |
Countries
United States
Outcome results
None listed