Status:
COMPLETED
A Multiple Ascending Dose Study of BMS-650032 in HCV Infected Subjects
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Chronic Hepatitis C
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
The primary purpose of this study is to assess the change in HCV RNA during dosing with BMS-650032 and during the follow-up period in subjects with chronic hepatitis C infection
Eligibility Criteria
Inclusion
- Chronically infected with HCV genotype 1
- Treatment naive
- HCV RNA viral load of ≥10\*5 IU/mL
- BMI 18 to 35kg/m²
Exclusion
- Women of childbearing potential (WOCBP)
- Any significant acute or chronic medical illness which is not stable or is not controlled with medication and not consistent with HCV infection
- HCV infected subjects who are treatment non-responder (defined as subject who received at least 12 weeks of SOC and continue to have a detectable HCV RNA level or subjects who did not attain a 2-log decline in HCV RNA levels at 12 weeks and stopped treatment
- HCV infected subjects who are treatment intolerant (defined as subject who are unable to receive at least 12 weeks of SOC due to toxicities associated with interferon and/or ribavirin
- HIV and/or HBV positive
- Major surgery within 4 weeks of study drug administration and any gastrointestinal surgery that could impact the absorption of study drug
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00722358
Start Date
December 1 2008
End Date
December 1 2009
Last Update
June 27 2011
Active Locations (5)
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1
Advanced Clinical Res Inst
Anaheim, California, United States, 92801
2
Orlando Clinical Research Center
Orlando, Florida, United States, 32809
3
Parexel International Corporation
Baltimore, Maryland, United States, 21225
4
Central Texas Clinical Research
Austin, Texas, United States, 78705