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NCT07226817
A Study to Assess the Relative Bioavailability of BMS-986435 and Food Effect on the BMS-986435 in Healthy Adult Participants
Conditions: Healthy Volunteers
Sex: All
Ages: 18 Years – 60 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 240
Sponsor: Bristol-Myers Squibb
Location: Quotient Miami Miami Florida
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 drug levels of selected BMS-986435 tablet formulations 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
Source: ClinicalTrials.gov (NCT07226817). StuddyBuddy aggregates publicly available trial information.