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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Page 1 of 2 (6 locations)

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