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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WITHDRAWN
PHASE1
INTERVENTIONAL
2014-10-31
2015-02-28
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
TRIPLE
Study Groups
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BMS-791325 - Part A, Dose 1
BMS-791325
Capsules, Oral, 300 mg, Single Dose, One day
Placebo
Capsules, Oral, Single Dose, One day
BMS-791325 - Part A, Dose 2
BMS-791325
Capsules, Oral, 900 mg, Single Dose, One day
Placebo
Capsules, Oral, Single Dose, One day
BMS-791325 - Part A, Dose 3
BMS-791325
Capsules, Oral, ≤1200 mg, Single Dose, One day
Placebo
Capsules, Oral, Single Dose, One day
BMS-791325 - Part B, Dose 1
BMS-791325
Capsules, Oral, 300 mg, Every 12 hours, 14 days
Placebo
Capsules, Oral, Every 12 hours, 14 days
BMS-791325 - Part B, Dose 2
BMS-791325
Capsules, Oral, 900 mg, once daily 14 days
Placebo
Capsules, Oral, Once Daily, 14 days
BMS-791325 - Part B, Dose 3
BMS-791325
Capsules, Oral, ≤1200 mg, Every 12 hours or once daily, 14 days
Placebo
Capsules, Oral, Every 12 hours or once daily, 14 days
Interventions
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BMS-791325
Capsules, Oral, 300 mg, Single Dose, One day
BMS-791325
Capsules, Oral, 900 mg, Single Dose, One day
BMS-791325
Capsules, Oral, ≤1200 mg, Single Dose, One day
BMS-791325
Capsules, Oral, 300 mg, Every 12 hours, 14 days
BMS-791325
Capsules, Oral, 900 mg, once daily 14 days
BMS-791325
Capsules, Oral, ≤1200 mg, Every 12 hours or once daily, 14 days
Placebo
Capsules, Oral, Single Dose, One day
Placebo
Capsules, Oral, Every 12 hours, 14 days
Placebo
Capsules, Oral, Once Daily, 14 days
Placebo
Capsules, Oral, Every 12 hours or once daily, 14 days
Eligibility Criteria
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Inclusion Criteria
* First generation Japanese. Subject born in Japan and has not lived outside of Japan for \> 10 years, and subject can trace maternal and paternal Japanese ancestry
Exclusion Criteria
* Women who are pregnant, breastfeeding, or unwilling or unable to use an acceptable method of birth control.
* Gastrointestinal disease that may impact the absorption of study drug or that required treatment with a protocon inhibitor, antacid or H2 blocker.
* History of eczema, psoriasis, or any intermittent or active dermatitis.
* Positive for HIV or HCV
20 Years
49 Years
ALL
Yes
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution
Cypress, California, United States
Countries
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Related Links
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BMS clinical trial educational resource
Investigator Inquiry form
Other Identifiers
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AI443-011
Identifier Type: -
Identifier Source: org_study_id
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