Evaluate the Bioavailability Between 2 BMS-986141 Formulations in Healthy Participants
Phase 1
Withdrawn
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT03035734
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
Open label, randomized, 4-period crossover study with single doses of BMS-986141 given to healthy female subjects of non-childbearing potential and healthy males.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Healthy participants as determined by no significant deviations in normal medical and surgical history and assessments
- Body mass index 18.0 kg/m2 to 32.0 kg/m2
- females must be of non-childbearing potential
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Exclusion Criteria
- known bleeding or coagulation disorders
- acute or chronic medical illness
- history of nausea or chronic diarrhea that lasts over 4 weeks
- history of periodontal disease or gingivitis which required treatment
- other exclusion criteria may apply
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description B BMS-986141 Form B tablet (low dose) Single oral dose BMS-986141 Form B tablet (low-dose) under fasting conditions A BMS-986141 Form A Tablet Single oral dose BMS-986141 Form A tablet under fasting conditions C BMS-986141 Form B tablet (high dose) Single oral dose BMS-986141 Form B tablet (high-dose) under fasting conditions D BMS-986141 Form B tablet (high dose) Single oral dose BMS-986141 Form B tablet (high-dose) under fed conditions
- Primary Outcome Measures
Name Time Method Evaluate the bioavailability between BMS-986141 Form B tablet compared to the Form A reference tablet 4 weeks
- Secondary Outcome Measures
Name Time Method Further characterize safety and tolerability of BMS-986141 by assessing adverse events and other physical assessments throughout study conduct 4 weeks