A Single Ascending Dose Study of BMS-791325 in HCV Infected Subjects
| Status: | Completed |
|---|---|
| Conditions: | Hepatitis, Hepatitis, Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 4/21/2016 |
| Start Date: | May 2008 |
| End Date: | June 2009 |
Placebo-Controlled Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of BMS-791325 in Subjects Chronically Infected With Hepatitis C Virus Genotype 1
The primary purpose of this study is to evaluate the safety profile and tolerability of
single oral doses of BMS-791325 in subjects with chronic hepatitis C infection
single oral doses of BMS-791325 in subjects with chronic hepatitis C infection
Inclusion Criteria:
- Chronically infected with HCV genotype 1
- Treatment naive or treatment non-responders or treatment intolerant
- HCV RNA viral load of ≥10*5* IU/mL
- BMI 18 to 35 kg/m²
Exclusion Criteria:
- Any significant acute or chronic medical illness which is not stable or is not
controlled with medication and not consistent with HCV infection
- Major surgery within 4 weeks of study drug administration and any gastrointestinal
surgery that could impact the absorption of study drug
- Co-infection with HIV or HBV
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