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This is a Phase 1 open-label study of the effect of itraconazole on the pharmacokinetics of CTP-543 in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CTP-543 | Experimental | On Day 1, participants will receive a single oral dose of CTP-543. Following a washout period on Days 2 and 3, participants will receive a single oral dose of itraconazole on Day 4 through Day 8, with a single oral dose of CTP-543 being co-administered on Day 7. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CTP-543 | Drug | Itraconazole in solution dosage form |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-t | Area Under the Plasma Concentration-Time Profile | 48 hours |
| AUC0-inf | Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time | 48 hours |
| Cmax | Maximum observed concentration of drug in plasma | 48 hours |
| Tmax | Time to reach maximum observed concentration of drug in plasma | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events (AEs) | An adverse event is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention | Up to 40 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Pharmacology of Miami | Miami | Florida | 33014 | United States |
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