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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CTP-543 | Experimental | Subjects will receive a single 2 mg dose of midazolam on Day 1. Starting on Day 3, 12 mg dose of CTP-543 will be administered (q12 hrs) for 14 consecutive days (up to Day 16). On Day 16, subjects will be co-administered a single 2 mg midazolam dose along with the morning dose of CTP-543. The second dose of CTP-543 will be administered as scheduled on Day 16. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Midazolam | Drug | 2 mg Day 1 and Day 16 |
| |
| CTP-543 |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum observed concentration | Day 14, 15, 16, Discharge (Day 17) |
| Tmax | Time to reach maximum observed concentration | Day 14, 15, 16, Discharge (Day 17) |
| AUC0-inf | Area under the concentration-time curve from time 0 extrapolated to infinity | 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 | Day 14, 15, 16, Discharge (Day 17) |
| λz | Terminal elimination rate constant | Day 14, 15, 16, Discharge (Day 17) |
| t1/2 | Apparent terminal half-life | Day 14, 15, 16, Discharge (Day 17) |
| CL/F | Apparent total plasma clearance (Midazolam only) | Day 1, 2, 16, Discharge (Day 17) |
| Vz/F | Apparent volume of distribution (Midazolam only) | Day 1, 2, 16, Discharge (Day 17) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Screening (within 21 days prior to Day 1) through follow-up (approximately 7 days after last study drug administration) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Pharmacology of Miami, LLC | Miami | Florida | 33014 | United States |
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Drug |
12 mg q12 hour for 14 consecutive days starting on Day 3 |
|
| D006571 | Heterocyclic Compounds |