Status:
COMPLETED
Single-Dose Pharmacokinetics of BMS-790052 in Participants With Hepatic Impairment
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Hepatic Insufficiency
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to assess the effects of hepatic impairment on the single dose pharmacokinetics of BMS-790052.
Eligibility Criteria
Inclusion
- Key
- Male and female subjects aged 18 to 70 years, with hepatic impairment conforming to Child-Pugh class A, B or C
- Healthy subjects to the extent possible matched to the first four hepatically impaired subject in each Child-Pugh class with regard to age (approximately ± 10 years), body weight (approximately ± 20%) and gender
- Key
Exclusion
- History of esophageal and gastric variceal bleeding within past 6 months
- Primarily cholestatic liver diseases
- Active alcoholic hepatitis
- Stable encephalopathy of \>= Stage 2
- Presence of severe ascites or edema
- Presence of hepatopulmonary or hepatorenal syndrome
- Positive for HCV, unless HCV RNA is undetectable
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT00859053
Start Date
March 1 2009
End Date
September 1 2009
Last Update
October 8 2015
Active Locations (2)
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1
Advanced Clinical Research Institute
Anaheim, California, United States, 92801
2
Orlando Clinical Research Center
Orlando, Florida, United States, 32809