A Multiple Ascending Dose Study of BMS-650032 in HCV Infected Subjects
NCT ID: NCT00722358
Last Updated: 2011-06-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
15 participants
INTERVENTIONAL
2008-12-31
2009-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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BMS-650032
BMS-650032
Capsule, Oral, Q12h, 3/5 days
Panel 1: 200 mg
Panel 2: 400 mg
Panel 3: 600 mg
Placebo
Placebo
Capsule, Oral, Q 12h, 3/5 days
Panel 1: matching placebo
Panel 2: matching placebo
Panel 3: matching placebo
Interventions
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BMS-650032
Capsule, Oral, Q12h, 3/5 days
Panel 1: 200 mg
Panel 2: 400 mg
Panel 3: 600 mg
Placebo
Capsule, Oral, Q 12h, 3/5 days
Panel 1: matching placebo
Panel 2: matching placebo
Panel 3: matching placebo
Eligibility Criteria
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Inclusion Criteria
* Treatment naive
* HCV RNA viral load of ≥10\*5 IU/mL
* BMI 18 to 35kg/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
* 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
18 Years
60 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Bristol-Myers Squibb
Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Advanced Clinical Res Inst
Anaheim, California, United States
Orlando Clinical Research Center
Orlando, Florida, United States
Parexel International Corporation
Baltimore, Maryland, United States
Central Texas Clinical Research
Austin, Texas, United States
Local Institution
Santurce, , Puerto Rico
Countries
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Related Links
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Investigator Inquiry form
Other Identifiers
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AI447-004
Identifier Type: -
Identifier Source: org_study_id
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