NCT07226817 A Study to Assess the Relative Bioavailability of BMS-986435 and Food Effect on the BMS-986435 in Healthy Adult Participants
| NCT ID | NCT07226817 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Bristol-Myers Squibb |
| Condition | Healthy Volunteers |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2025-11-12 |
| Primary Completion | 2026-07-01 |
Trial Parameters
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Brief Summary
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 selected BMS-986435 tablet formulation will also be evaluated.
Eligibility Criteria
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