RecruitingPhase 1NCT07226817

A Study to Assess the Relative Bioavailability of BMS-986435 and Food Effect on the BMS-986435 in Healthy Adult Participants

A Phase 1, Open-label, Single-site, Multi-part, Non-randomized, Parallel-group Study to Assess the Relative Bioavailability of BMS-986435 Tablet Formulations (Parts 1 & 2) and Food Effect on the Selected BMS-986435 Tablet Formulation (Part 3) in Healthy Adult Participants


Sponsor

Bristol-Myers Squibb

Enrollment

140 participants

Start Date

Nov 12, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 60 Years

Inclusion Criteria3

  • 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

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Interventions

DRUGBMS-986435

Specified dose on specified days


Locations(1)

Quotient Miami

Miami, Florida, United States

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NCT07226817


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