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This is a four-arm, randomized, crossover, placebo and active controlled study to evaluate of the effect of therapeutic and supratherapeutic doses of CTP-543 on the QT/QTc intervals in healthy volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A: Therapeutic Dose | Experimental | Single oral dose of 12mg CTP-543 |
|
| Treatment B: Supratherapeutic Dose | Experimental | Single oral dose of 48mg CTP-543 |
|
| Treatment D: Placebo | Placebo Comparator | Single oral dose of 1 Placebo tablet |
|
| Treatment C: Positive Control | Active Comparator | Single oral dose of 400mg Moxifloxacin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CTP-543 | Drug | CTP-543 12 mg (1 x 12 mg tablet), dosed with water |
| |
| Measure | Description | Time Frame |
|---|---|---|
| TQT Analysis | Analysis of the change from pre-dose-averaged baseline Fridericia's corrected QT interval (QTcF) at each post-dose timepoint | Before dosing (pre-dose) through 24 hours post-dose on Day 1, Day 4, Day 7, and Day 10 |
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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 |
|---|---|
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| CTP-543 |
| Drug |
CTP-543 48 mg (4 x 12 mg tablet) dosed with water |
|
| Moxifloxacin | Drug | Moxifloxacin (1 x 400 mg tablet) dosed with water |
|
| Placebo | Drug | Placebo (1 tablet) dosed with water |
|
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |