A Study to Assess the Effects on the Single-Dose Drug Levels of Mavacamten in Healthy Participants

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: Mavacamten Capsule 2; Drug: Mavacamten Capsule 3; Drug: Mavacamten Capsule 1

Study type: Interventional

Funder types: Industry

Identifiers

NCT05658146

CV027-1052

Details and patient eligibility

About

The purpose of this study is to assess the effects on the single-dose drug levels of mavacamten in healthy participants.

Enrollment: 95 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Body mass index between 18 and 32 kilograms/meter squared (kg/m^2) inclusive, at the screening visit.
• Healthy, as determined by physical examination, vital signs, electrocardiograms (ECGs), and clinical laboratory assessments (including hematology, chemistry, and urinalysis) within the normal range at the screening visit and/or on Day -1.
• Cytochrome P450 (CYP) 2C19 normal, rapid, or ultrarapid metabolizer, as determined by genotyping during screening.

Exclusion criteria

• Any significant acute or chronic medical illness.
• Current or history of clinically significant cardiac condition, including but not limited to arrhythmia, left ventricular systolic dysfunction, coronary heart disease; current, history, or family history of hypertrophic cardiomyopathy; or evidence of prior myocardial infarction based on ECGs.
• CYP2C19 poor (*2/*2, *3/*3, or *2/*3) or intermediate (*1/*2, *1/*3, *2/*17) metabolizer, as determined by genotyping during screening.
• Use of CYP2C19 and CYP3A4 inducers or inhibitors within 28 days of study intervention administration.

Note: 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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95 participants in 6 patient groups

Sequence 1

Experimental group

Treatment:

Drug: Mavacamten Capsule 1

Drug: Mavacamten Capsule 3

Drug: Mavacamten Capsule 2

Sequence 2

Experimental group

Treatment:

Drug: Mavacamten Capsule 1

Drug: Mavacamten Capsule 3

Drug: Mavacamten Capsule 2

Sequence 3

Experimental group

Treatment:

Drug: Mavacamten Capsule 1

Drug: Mavacamten Capsule 3

Drug: Mavacamten Capsule 2

Sequence 4

Experimental group

Treatment:

Drug: Mavacamten Capsule 1

Drug: Mavacamten Capsule 3

Drug: Mavacamten Capsule 2

Sequence 5

Experimental group

Treatment:

Drug: Mavacamten Capsule 1

Drug: Mavacamten Capsule 3

Drug: Mavacamten Capsule 2

Sequence 6

Experimental group

Treatment:

Drug: Mavacamten Capsule 1

Drug: Mavacamten Capsule 3

Drug: Mavacamten Capsule 2