About this trial
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
This trial accepts healthy volunteersQualifiers
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/
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
BMS-986435
DrugSpecified dose on specified days
Treatment groups
7
Treatment groupsSee each treatment group below.
Trial outcomes
Primary outcomes
Maximum observed concentration (Cmax)
Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Secondary outcomes
Area under the plasma concentration-time curve truncated at 72-hour (AUC(0-72h))
Time of maximum observed concentration (Tmax)
Half-life (T-HALF)
Apparent total body clearance (CLT/F)
Sponsors and contacts
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