A Single Ascending Dose Study of BMS-791325 in HCV Infected Subjects

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Chronic Hepatitis C

In brief

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

Key facts

Study ID

NCT00664625

Run by

Bristol-Myers Squibb

People needed

24

Starts

2008-05-01

Expected to finish

2009-06-01

Last updated by the study team

2015-10-09

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Advanced Clinical Res Inst — Anaheim, California, United States
• West Coast Clinical Trials, Llc — Cypress, California, United States
• Washington University School Of Medicine — St Louis, Missouri, United States
• University Of Pennsylvania — Philadelphia, Pennsylvania, United States
• Alamo Medical Research — San Antonio, Texas, United States
• Local Institution — Buenos Aires, Buenos Aires, Argentina

Full record on ClinicalTrials.gov

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