The purpose of this study to assess the relative bioavailability of 5 mg Mavacamten opened capsule administered via nasogastric tube compared to intact oral 5 mg Mavacamten in healthy volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
34
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Local Institution - 0001
San Antonio, Texas, United States
Maximum observed concentration (Cmax)
Time frame: Up to 37 days
Area under the concentration-time curve from time 0 to the last quantifiable time point (AUC[0-T])
Time frame: Up to 37 days
Area under the concentration-time curve from time 0 to 72 hours (AUC[0-72])
Time frame: Up to 37 days
Area under the concentration-time curve from time 0 to infinite time (AUC[0-INF])
Time frame: Up to 37 days
Time of maximum observed plasma concentration (Tmax)
Time frame: Up to 37 days
Terminal half-life (T-HALF)
Time frame: Up to 37 days
Apparent clearance (CLT/F)
Time frame: Up to 37 days
Apparent volume of distribution (Vz/F)
Time frame: Up to 37 days
Number of participants with adverse events (AEs)
Time frame: Up to 37 days
Number of participants with serious adverse events (SAEs)
Time frame: Up to 37 days
Number of participants with vital sign abnormalities
Time frame: Up to 37 days
Number of participants with electrocardiogram (ECG) findings
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Up to 37 days
Number of participants with physical examination findings
Time frame: Up to 37 days
Number of participants with abnormalities in clinical laboratory evaluations
Time frame: Up to 37 days