The purpose of the study is to evaluate the effect between two different single doses of mavamten in healthy participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
84
Specified dose on specified days
Local Institution - 0001
Miami, Florida, United States
Local Institution - 0002
Saint Paul, Minnesota, United States
Maximum observed plasma concentration (Cmax)
Time frame: Predose and post-dose up to Day 80
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T])
Time frame: Predose and post-dose up to Day 80
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC [INF])
Time frame: Predose and post-dose up to Day 80
Time of maximum observed plasma concentration (Tmax)
Time frame: Predose and post-dose up to Day 80
Terminal Half-life (T-Half)
Time frame: Predose and post-dose up to Day 80
Number of Participants with Adverse Events (AEs)
Time frame: Up to Day 80
Number of Participants with Serious AEs (SAEs)
Time frame: Up to Day 80
Number of Participants with Vital Sign Abnormalities
Time frame: Up to Day 80
Number of Participants with Electrocardiogram (ECG) Abnormalities
Time frame: Up to Day 80
Number of Participants with Physical Examination Abnormalities
Time frame: Up to Day 80
Number of Participants with Clinical Laboratory Abnormalities
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Time frame: Up to Day 80