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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 Fed:Fasted | Experimental | Period 1: CTP-543 12 mg fed Period 2: CTP-543 12 mg fasted |
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| Sequence 2 Fasted:Fed | Experimental | Period 1: CTP-543 12 mg fasted Period 2: CTP-543 12 mg fed |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CTP-543 | Drug | For each period, subjects will be dosed with CTP-543 12 mg (1 x 12 mg tablet) |
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| Measure | Description | Time Frame |
|---|---|---|
| Bioavailability and Pharmacokinetic Profile of CTP-543: Cmax | Maximum observed concentration | 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 | 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 | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic Profile of major metabolites: Cmax | Maximum observed concentration | 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 |
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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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Time to reach maximum observed concentration |
| 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-Tlast) | Area under the concentration-time curve from time 0 to the time of the last observed/measured non-zero concentration | 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 | 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 | Screening through 7 to 10 days after final dose administration |