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

Launched by BRISTOL-MYERS SQUIBB · Dec 13, 2022

Keywords

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Gender

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Eligibility criteria

• 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 Officials