Hepatic Impaired Subjects Compared to Healthy Subjects Receiving Multi-dose BMS-650032
Multiple-Dose Pharmacokinetics of BMS-650032 in Subjects With Hepatic Impairment Compared to Healthy Subjects
1 other identifier
interventional
28
1 country
2
Brief Summary
The purpose of this study is to assess the effects of hepatic impairment on the multiple dose pharmacokinetics of BMS-650032.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Dec 2009
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 24, 2009
CompletedFirst Posted
Study publicly available on registry
November 25, 2009
CompletedStudy Start
First participant enrolled
December 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedOctober 26, 2011
October 1, 2011
1.7 years
November 24, 2009
October 25, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Pharmacokinetics parameters including Cmax, Tmax,AUC(TAU),Vss/F, T-Half, CLT/F and AI
Day 10
Secondary Outcomes (2)
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
Study Arms (4)
BMS-650032 in Child-Pugh A
ACTIVE COMPARATORBMS-650032 in Child-Pugh B
ACTIVE COMPARATORBMS-650032 in Child-Pugh C
ACTIVE COMPARATORBMS-650032 in Healthy Subjects
ACTIVE COMPARATORInterventions
Capsules, Oral, 200 mg, BID, 7 Days
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Advanced Clinical Res Inst
Anaheim, California, 92801, United States
Orlando Clinical Research Center
Orlando, Florida, 32809, United States
Related Publications (1)
Eley T, He B, Chang I, Colston E, Child M, Bedford W, Kandoussi H, Pasquinelli C, Marbury TC, Bertz RJ. The effect of hepatic impairment on the pharmacokinetics of asunaprevir, an HCV NS3 protease inhibitor. Antivir Ther. 2015;20(1):29-37. doi: 10.3851/IMP2773. Epub 2014 Apr 7.
PMID: 24704773DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 24, 2009
First Posted
November 25, 2009
Study Start
December 1, 2009
Primary Completion
August 1, 2011
Study Completion
August 1, 2011
Last Updated
October 26, 2011
Record last verified: 2011-10