A Study to Assess the Relative Bioavailability of BMS-986435 and Food Effect on the BMS-986435 in Healthy Adult Participants
Purpose
This study is designed to evaluate the relative bioavailability (rBA) of multiple test tablet formulations of BMS-986435 compared to an equal dose of the BMS-986435 reference tablet formulation. The effect of food on the drug levels of selected BMS-986435 tablet formulations will also be evaluated.
Condition
- Healthy Volunteers
Eligibility
- Eligible Ages
- Between 18 Years and 60 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Participants must have a body weight of ≥ 45 kg and BMI between 18 and 32 kg/m2, inclusive - Participants must be healthy as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), clinical laboratory assessments - Participants must have documented left ventricular ejection fraction (LVEF) ≥ 60% and absence of significant cardiac abnormality at screening, as determined by local transthoracic echocardiogram (TTE) assessment - Other protocol-defined Inclusion/
Exclusion Criteria
apply
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
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Experimental Treatment A |
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Experimental Treatment B |
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Experimental Treatment C |
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Experimental Treatment D |
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Experimental Treatment E |
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Experimental Treatment F |
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Experimental Treatment G |
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Experimental Treatment H |
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Experimental Treatment I |
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Experimental Treatment J |
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Experimental Treatment K |
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Experimental Treatment L |
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Recruiting Locations
Quotient Miami
Miami, Florida 33126
Miami, Florida 33126
Contact:
Juliet Vento, Site 0001
Juliet Vento, Site 0001
More Details
- Status
- Recruiting
- Sponsor
- Bristol-Myers Squibb
Study Contact
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com855-907-3286
Clinical.Trials@bms.com