Single-Dose Pharmacokinetics of BMS-790052 in Participants With Hepatic Impairment



Status:Completed
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 70
Updated:4/21/2016
Start Date:March 2009
End Date:September 2009

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Single-Dose Pharmacokinetics of BMS-790052 in Subjects With Hepatic Impairment Compared to Healthy Subjects

The purpose of this study is to assess the effects of hepatic impairment on the single dose
pharmacokinetics of BMS-790052.


Key Inclusion Criteria:

- 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 Criteria:

- 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
We found this trial at
2
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5055 South Orange Ave Orlando FL 32909
Orlando, Florida 32806
407-240-7878
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Anaheim, California 92801
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Anaheim, CA
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