A Study to Assess the Effects on the Single-Dose Drug Levels of Mavacamten in Healthy Participants
Phase 1
Completed
- Conditions
- Healthy Participants
- Interventions
- Registration Number
- NCT05658146
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to assess the effects on the single-dose drug levels of mavacamten in healthy participants.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 95
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Sequence 1 Mavacamten Capsule 1 - Sequence 1 Mavacamten Capsule 2 - Sequence 2 Mavacamten Capsule 3 - Sequence 6 Mavacamten Capsule 1 - Sequence 2 Mavacamten Capsule 1 - Sequence 1 Mavacamten Capsule 3 - Sequence 2 Mavacamten Capsule 2 - Sequence 4 Mavacamten Capsule 1 - Sequence 4 Mavacamten Capsule 2 - Sequence 4 Mavacamten Capsule 3 - Sequence 5 Mavacamten Capsule 3 - Sequence 6 Mavacamten Capsule 3 - Sequence 3 Mavacamten Capsule 1 - Sequence 5 Mavacamten Capsule 1 - Sequence 3 Mavacamten Capsule 2 - Sequence 5 Mavacamten Capsule 2 - Sequence 6 Mavacamten Capsule 2 - Sequence 3 Mavacamten Capsule 3 -
- Primary Outcome Measures
Name Time Method Maximum Observed Serum Concentration (Cmax) From Day 1 up to Day 35±2 of each period Area Under the Serum Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration [AUC(0-T)] From Day 1 up to Day 35±2 of each period Area Under the Serum Concentration-time Curve from Time Zero Extrapolated to Infinite Time [AUC(INF)] From Day 1 up to Day 35±2 of each period
- Secondary Outcome Measures
Name Time Method Area Under the Serum Concentration-time Curve from Time 0 to 72 Hours [AUC(0-72)] From Day 1 to Day 4 of each period Time of Maximum Observed Serum Concentration (Tmax) From Day 1 up to Day 35±2 of each period Terminal Half-life (T-HALF) From Day 1 up to Day 35±2 of each period Number of Participants with Adverse Events (AEs) Up to 35 days post discontinuation of dosing Number of Participants with Serious Adverse Events (SAEs) Up to 35 days post discontinuation of dosing Number of Participants with Vital Sign Abnormalities Up to 35 days post discontinuation of dosing Number of Participants with Electrocardiograms (ECG) Abnormalities Up to 35 days post discontinuation of dosing Number of Participants with Physical Examination Abnormalities Up to 35 days post discontinuation of dosing Number of Participants with Clinical Laboratory Evaluation Abnormalities Up to 35 days post discontinuation of dosing
Trial Locations
- Locations (3)
Local Institution - 0001
🇺🇸Anaheim, California, United States
Local Institution - 0002
🇺🇸Miami, Florida, United States
Local Institution - 0003
🇺🇸Springfield, Missouri, United States