Healthy Participants
Conditions
Keywords
Healthy Participants, Mavacamten, Bioequivalence
Brief summary
The purpose of this study is to assess the effects on the single-dose drug levels of mavacamten in healthy participants.
Interventions
DRUGMavacamten Capsule 1
Specified dose on specified days
DRUGMavacamten Capsule 2
Specified dose on specified days
DRUGMavacamten Capsule 3
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
| 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 |
| Number of Participants with Electrocardiograms (ECG) Abnormalities | Up to 35 days post discontinuation of dosing |
| 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 |
Countries
United States
Outcome results
None listed