Not Yet Recruiting
A Study to Assess the Effects on the Single-Dose Drug Levels of Mavacamten in Healthy Participants - CV027-1052
Updated: 13 December, 2022 | ClinicalTrials.gov
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Not Yet Recruiting
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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.
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