Healthy Participants
Conditions
Keywords
Mavacamten, Healthy Participants, Bioequivalence, Hypertrophic Cardiomyopathy
Brief summary
The purpose of this study is to evaluate the effects on the single-dose drug levels of mavacamten in healthy participants.
Interventions
DRUGMavacamten
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
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 kg/m\^2, inclusive, at the Screening Visit * Healthy, as determined by physical examination, vital signs, electrocardiograms (ECGs), and clinical laboratory assessments within the normal range at the screening visit and/or on Day -1
Exclusion criteria
* Current or recent (within 3 months of study intervention administration) gastrointestinal disease * History of any significant drug allergy (such as anaphylaxis or hepatotoxicity) Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum observed plasma concentration (Cmax) | Up to approximately 1 month |
| Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration ((AUC(0-T)) | Up to approximately 1 month |
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time ((AUC(INF)) | Up to approximately 1 month |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with serious adverse events (SAEs) | Up to approximately 1 month |
| Number of participants with vital sign abnormalities exceeding predefined thresholds | Up to approximately 1 month |
| Time of maximum observed plasma concentration (Tmax) | Up to approximately 1 month |
| Number of participants with physical exam abnormalities | Up to approximately 1 month |
| Number of participants with clinical laboratory evaluation abnormalities | Up to approximately 1 month |
| Number of participants with electrocardiogram (ECG) abnormalities | Up to approximately 1 month |
| Terminal half-life (T-HALF) | Up to approximately 1 month |
| Number of participants with adverse events (AEs) | Up to approximately 1 month |
Countries
United States
Outcome results
None listed