The purpose of this study is to evaluate the effects on the single-dose drug levels of mavacamten in healthy participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
158
Specified dose on specified days
Clinical pharmacology of Miami
Miami, Florida, United States
Advanced Pharma CR, LLC
Miami, Florida, United States
QPS Springfield
Springfield, Missouri, United States
Ppd Phase I Clinic
Austin, Texas, United States
Maximum observed plasma concentration (Cmax)
Time frame: 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))
Time frame: Up to approximately 1 month
Area under the plasma concentration-time curve from time zero extrapolated to infinite time ((AUC(INF))
Time frame: Up to approximately 1 month
Time of maximum observed plasma concentration (Tmax)
Time frame: Up to approximately 1 month
Terminal half-life (T-HALF)
Time frame: Up to approximately 1 month
Number of participants with adverse events (AEs)
Time frame: Up to approximately 1 month
Number of participants with serious adverse events (SAEs)
Time frame: Up to approximately 1 month
Number of participants with vital sign abnormalities exceeding predefined thresholds
Time frame: Up to approximately 1 month
Number of participants with electrocardiogram (ECG) abnormalities
Time frame: Up to approximately 1 month
Number of participants with physical exam abnormalities
Time frame: Up to approximately 1 month
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Number of participants with clinical laboratory evaluation abnormalities
Time frame: Up to approximately 1 month