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

Phase 1

Completed

• Conditions: Hepatic Insufficiency
• Interventions: Drug: BMS-650032

• Registration Number: NCT01019070
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2009-11-24
• Study First Submitted QC: 2009-11-24
• Study First Posted: 2009-11-25
• Study Start: 2009-12
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-25
• Last Update Posted: 2011-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BMS-650032 in Child-Pugh A	BMS-650032	-
BMS-650032 in Child-Pugh B	BMS-650032	-
BMS-650032 in Child-Pugh C	BMS-650032	-
BMS-650032 in Healthy Subjects	BMS-650032	-

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics parameters including Cmax, Tmax,AUC(TAU),Vss/F, T-Half, CLT/F and AI	Day 10

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Advanced Clinical Res Inst; 🇺🇸 Anaheim, California, United States

Orlando Clinical Research Center; 🇺🇸 Orlando, Florida, United States