A Study to Assess the Effects on the Single-Dose Drug Levels of Mavacamten in Healthy Participants
Completed · Phase 1
Conditions studied: Healthy Participants
In brief
The purpose of this study is to assess the effects on the single-dose drug levels of mavacamten in healthy participants.
Key facts
- Study ID
- NCT05658146
- Run by
- Bristol-Myers Squibb
- People needed
- 95
- Starts
- 2023-01-06
- Expected to finish
- 2023-07-05
- Last updated by the study team
- 2023-10-11
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Local Institution - 0001 — Anaheim, California, United States
- Local Institution - 0002 — Miami, Florida, United States
- Local Institution - 0003 — Springfield, Missouri, United States
Full record on ClinicalTrials.gov
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