This is an open-label, single-dose, two period crossover study to evaluate the effect of food on the bioavailability of the To-Be-Marketed Formulation of CTP-543 in Healthy Volunteers
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
16
For each period, subjects will be dosed with CTP-543 12 mg (1 x 12 mg tablet)
Clinical Pharmacology of Miami, LLC
Miami, Florida, United States
Bioavailability and Pharmacokinetic Profile of CTP-543: Cmax
Maximum observed concentration
Time frame: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose and Day 6/discharge
Bioavailability and Pharmacokinetic Profile of CTP-543: Tmax
Time to reach maximum observed concentration
Time frame: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose and Day 6/discharge
Bioavailability and Pharmacokinetic Profile of CTP-543: AUC(0-Tlast)
Area under the concentration-time curve from time 0 to the time of the last observed/measured non-zero concentration
Time frame: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose and Day 6/discharge
Bioavailability and Pharmacokinetic Profile of CTP-543: AUC(0-inf)
Area under the concentration-time curve from time 0 extrapolated to infinity
Time frame: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose and Day 6/discharge
Pharmacokinetic Profile of major metabolites: Cmax
Maximum observed concentration
Time frame: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose and Day 6/discharge
Pharmacokinetic Profile of major metabolites: Tmax
Time to reach maximum observed concentration
Time frame: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose and Day 6/discharge
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Pharmacokinetic Profile of major metabolites: AUC(0-Tlast)
Area under the concentration-time curve from time 0 to the time of the last observed/measured non-zero concentration
Time frame: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose and Day 6/discharge
Pharmacokinetic Profile of major metabolites: AUC(0-inf)
Area under the concentration-time curve from time 0 extrapolated to infinity
Time frame: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose and Day 6/discharge
Assessment of Safety and Tolerability following administration of CTP-543
Number of adverse events including abnormal clinical laboratory findings, abnormal physical examinations, abnormal ECGs and abnormal vital signs tabulated for each subject
Time frame: Screening through 7 to 10 days after final dose administration