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 |
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.
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
sites
5055 South Orange Ave Orlando FL 32909
Orlando, Florida 32806
Orlando, Florida 32806
407-240-7878
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