Status:
COMPLETED
A Single Ascending Dose Study of BMS-791325 in HCV Infected Subjects
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Chronic Hepatitis C
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
PHASE2
Brief Summary
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00664625
Start Date
May 1 2008
End Date
June 1 2009
Last Update
October 9 2015
Active Locations (6)
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1
Advanced Clinical Res Inst
Anaheim, California, United States, 92801
2
West Coast Clinical Trials, Llc
Cypress, California, United States, 90630
3
Washington University School Of Medicine
St Louis, Missouri, United States, 63110
4
University Of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104