Clinical Pharmacology of Miami, LLC
Miami, Florida, 33014, United States
NCT Number: NCT05467709
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
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Notify Me18 year–60 year
All sexes
Interventional
Phase 1
Miami, Florida, 33014, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
2 mg Day 1 and Day 16
12 mg q12 hour for 14 consecutive days starting on Day 3
Time frame: Day 14, 15, 16, Discharge (Day 17)
Maximum observed concentration
Time frame: Day 14, 15, 16, Discharge (Day 17)
Time to reach maximum observed concentration
Time frame: Day 14, 15, 16, Discharge (Day 17)
Area under the concentration-time curve from time 0 extrapolated to infinity
Time frame: Day 14, 15, 16, Discharge (Day 17)
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)
Terminal elimination rate constant
Time frame: Day 14, 15, 16, Discharge (Day 17)
Apparent terminal half-life
Time frame: Day 1, 2, 16, Discharge (Day 17)
Apparent total plasma clearance (Midazolam only)
Time frame: Day 1, 2, 16, Discharge (Day 17)
Apparent volume of distribution (Midazolam only)
Time frame: Screening (within 21 days prior to Day 1) through follow-up (approximately 7 days after last study drug administration)
Number of adverse events, including abnormal clinical laboratory findings, abnormal physical examinations, abnormal ECGs and abnormal vital signs tabulated for each subject
Concert Pharmaceuticals
Industry
A Phase 1, Open-Label, Fixed-Sequence, Drug-Drug Interaction Study To Evaluate The Effect Of Multiple Doses of CTP-543 On The Pharmacokinetics Of Single Doses of Midazolam In Healthy Subjects
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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