A Single Ascending Dose Study of BMS-791325 in HCV Infected Subjects
NCT ID: NCT00664625
Last Updated: 2015-10-09
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
PHASE1/PHASE2
24 participants
INTERVENTIONAL
2008-05-31
2009-06-30
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
DOUBLE
Study Groups
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1
BMS-791325 (100 mg)
or
placebo match for (100 mg)
BMS-791325
Capsules, Oral, Once Daily, Single Dose
Placebo
Capsules, Oral, Once Daily, Single Dose
2
BMS-791325 (300 mg)
or
placebo match for (300 mg)
BMS-791325
Capsules, Oral, Once Daily, Single Dose
Placebo
Capsules, Oral, Once Daily, Single Dose
3
BMS-791325 (900 mg)
or
placebo match for (900 mg)
BMS-791325
Capsules, Oral, Once Daily, Single Dose
Placebo
Capsules, Oral, Once Daily, Single Dose
4
BMS-791325 (potential dose between 10-800 mg)
or
placebo match for (10-800 mg)
BMS-791325
Capsules, Oral, Once Daily, Single Dose
Placebo
Capsules, Oral, Once Daily, Single Dose
Interventions
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BMS-791325
Capsules, Oral, Once Daily, Single Dose
Placebo
Capsules, Oral, Once Daily, Single Dose
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
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
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
Countries
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References
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Sims KD, Lemm J, Eley T, Liu M, Berglind A, Sherman D, Lawitz E, Vutikullird AB, Tebas P, Gao M, Pasquinelli C, Grasela DM. Randomized, placebo-controlled, single-ascending-dose study of BMS-791325, a hepatitis C virus (HCV) NS5B polymerase inhibitor, in HCV genotype 1 infection. Antimicrob Agents Chemother. 2014 Jun;58(6):3496-503. doi: 10.1128/AAC.02579-13. Epub 2014 Apr 14.
Related Links
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Investigator Inquiry form
Other Identifiers
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AI443-002
Identifier Type: -
Identifier Source: org_study_id
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