Study to Assess Relative Bioavailability of BMS-986435 Formulations in Healthy Adult Participants

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: BMS-986435

Study type: Interventional

Funder types: Industry

Identifiers

NCT06577259

CV029-1018

Details and patient eligibility

About

The purpose of this study is to assess the relative bioavailability of BMS-986435 tablet formulations in healthy adult male and female participants.

Enrollment: 25 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Body weight of ≥ 45 kg and a body mass index (BMI) between 18 and 32 kg/m^2, inclusive.
• Healthy as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG) and clinical laboratory assessments.
• Have documented left ventricular ejection fraction (LVEF) ≥ 60% and absence of significant cardiac abnormality.

Exclusion criteria

• Any acute or chronic medical illness.
• History of heart disease.
• Prior exposure to BMS-986435.
• Other protocol-defined Inclusion/Exclusion criteria apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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25 participants in 3 patient groups

Treatment A: BMS-986435 Reference Dose 1

Active Comparator group

Treatment:

Drug: BMS-986435

Treatment B: BMS-986435 Test Dose 1

Experimental group

Treatment:

Drug: BMS-986435

Treatment C: BMS-986435 Test Dose 2

Experimental group

Treatment:

Drug: BMS-986435