The purpose of this study is to assess the effects on the single-dose drug levels of mavacamten in healthy participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
95
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Local Institution - 0001
Anaheim, California, United States
Local Institution - 0002
Miami, Florida, United States
Local Institution - 0003
Springfield, Missouri, United States
Maximum Observed Serum Concentration (Cmax)
Time frame: 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)]
Time frame: 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)]
Time frame: From Day 1 up to Day 35±2 of each period
Area Under the Serum Concentration-time Curve from Time 0 to 72 Hours [AUC(0-72)]
Time frame: From Day 1 to Day 4 of each period
Time of Maximum Observed Serum Concentration (Tmax)
Time frame: From Day 1 up to Day 35±2 of each period
Terminal Half-life (T-HALF)
Time frame: From Day 1 up to Day 35±2 of each period
Number of Participants with Adverse Events (AEs)
Time frame: Up to 35 days post discontinuation of dosing
Number of Participants with Serious Adverse Events (SAEs)
Time frame: Up to 35 days post discontinuation of dosing
Number of Participants with Vital Sign Abnormalities
Time frame: Up to 35 days post discontinuation of dosing
Number of Participants with Electrocardiograms (ECG) Abnormalities
Time frame: Up to 35 days post discontinuation of dosing
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Number of Participants with Physical Examination Abnormalities
Time frame: Up to 35 days post discontinuation of dosing
Number of Participants with Clinical Laboratory Evaluation Abnormalities
Time frame: Up to 35 days post discontinuation of dosing