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

Completed · Phase 1

Conditions studied: Hepatic Insufficiency

In brief

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

Key facts

Study ID

NCT01019070

Run by

Bristol-Myers Squibb

People needed

28

Starts

2009-12-01

Expected to finish

2011-08-01

Last updated by the study team

2011-10-26

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Advanced Clinical Res Inst — Anaheim, California, United States
• Orlando Clinical Research Center — Orlando, Florida, United States

Full record on ClinicalTrials.gov

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