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

Bristol-Myers Squibb (BMS)

Status and phase: Active, not recruiting; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: BMS-986435

Study type: Interventional

Funder types: Industry

Identifiers

NCT07226817

CV029-1024

Details and patient eligibility

About

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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 7 patient groups

Treatment A

Experimental group

Treatment:

Drug: BMS-986435

Treatment B

Experimental group

Treatment:

Drug: BMS-986435

Treatment C

Experimental group

Treatment:

Drug: BMS-986435

Treatment D

Experimental group

Treatment:

Drug: BMS-986435

Treatment E

Experimental group

Treatment:

Drug: BMS-986435

Treatment F

Experimental group

Treatment:

Drug: BMS-986435

Treatment G

Experimental group

Treatment:

Drug: BMS-986435