this study purpose is to assess safety, tolerability and the pharmacokinetic (PK) profile of palovarotene in healthy Japanese and matched (with respect to sex, age, and weight) non-Asian subjects aged 18 to 55 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
18
oral capsules
oral capsules
Maximum (peak) plasma drug concentration
Time frame: pre-dose (0 hour), 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, and 72 hours post-drug administration.
Time to reach maximum (peak) plasma concentration following drug administration
Time frame: pre-dose (0 hour), 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, and 72 hours post-drug administration.
Area under the plasma concentration time curve from time zero to the last quantifiable time point, calculated by linear-log trapezoidal summation
Time frame: pre-dose (0 hour), 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, and 72 hours post-drug administration.
Area under the plasma concentration time curve from time zero to infinity, calculated by linear-log trapezoidal summation and extrapolated to infinity by addition of the last quantifiable plasma concentration divided by the elimination rate constant
Time frame: pre-dose (0 hour), 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, and 72 hours post-drug administration.
Terminal disposition rate constant/terminal rate constant, determined by linear regression of the terminal points of the log-linear plasma concentration-time curve
Time frame: pre-dose (0 hour), 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, and 72 hours post-drug administration.
Elimination half-life
Time frame: pre-dose (0 hour), 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, and 72 hours post-drug administration.
Apparent volume of distribution after non-intravenous (oral) administration
Time frame: pre-dose (0 hour), 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, and 72 hours post-drug administration.
Apparent total clearance of the drug from plasma after oral administration calculated by dose/ AUC(0-∞)
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Time frame: pre-dose (0 hour), 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, and 72 hours post-drug administration.