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A single center, Phase 1, open-label, fixed-sequence, drug-drug interaction study to evaluate the effect of multiple doses of Fluconazole, a CYP3A4 and CYP2C9 inhibitor, on the pharmacokinetics (PK) of CTP-543 in healthy subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CTP-543 and Fluconazole Treatment | Experimental | On Day 1, each subject will receive a single oral dose of 12 mg CTP-543. Following a washout on Day 2, each subject will receive an oral dose of 200 mg fluconazole once daily on Days 3 through to Day 8. On Day 7, approximately 1 hour after the 200 mg dose of fluconazole, each subject will receive a single oral dose of 12 mg CTP-543. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CTP-543 | Drug | 12 mg on Day 1 and Day 7 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum observed concentration | Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose |
| Tmax | Time to reach maximum observed concentration | Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose |
| λz | Terminal elimination rate constant | Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose |
| t1/2 | Apparent terminal half-life | Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose |
| AUC0-tlast | Area under the concentration-time curve from time 0 to the time of the last observed/measured non-zero concentration | Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose |
| AUC0-inf | Area under the concentration-time curve from time 0 extrapolated to infinity | Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose |
| 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 | Continuous from screening (within 21 days prior to Day 1) through Discharge (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 |
|---|---|
| D015725 | Fluconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Fluconazole |
| Drug |
200 mg once daily on Days 3 through to Day 8 |
|