This is a single center, Phase 1, open-label, fixed-sequence, drug-drug interaction study to determine the effect of CTP-543 on the pharmacokinetics (PK) of midazolam in healthy adult subjects
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
20
Clinical Pharmacology of Miami, LLC
Miami, Florida, United States
Cmax
Maximum observed concentration
Time frame: Day 14, 15, 16, Discharge (Day 17)
Tmax
Time to reach maximum observed concentration
Time frame: Day 14, 15, 16, Discharge (Day 17)
AUC0-inf
Area under the concentration-time curve from time 0 extrapolated to infinity
Time frame: Day 14, 15, 16, Discharge (Day 17)
AUC0-t
Area under the concentration-time curve from time 0 to the time of the last observed/measured non-zero concentration
Time frame: Day 14, 15, 16, Discharge (Day 17)
λz
Terminal elimination rate constant
Time frame: Day 14, 15, 16, Discharge (Day 17)
t1/2
Apparent terminal half-life
Time frame: Day 14, 15, 16, Discharge (Day 17)
CL/F
Apparent total plasma clearance (Midazolam only)
Time frame: Day 1, 2, 16, Discharge (Day 17)
Vz/F
Apparent volume of distribution (Midazolam only)
Time frame: Day 1, 2, 16, Discharge (Day 17)
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
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Time frame: Screening (within 21 days prior to Day 1) through follow-up (approximately 7 days after last study drug administration)