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The purpose of this study is to evaluate the effect of povorcitinib on the QT/QTc Interval in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group 1 | Experimental | Povorcitinib and placebo will be administered at the protocol defined doses. |
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| Treatment Group 2 | Experimental | Povorcitinib will be administered at the protocol defined doses. |
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| Treatment Group 3 | Placebo Comparator | Placebo will be administered at the protocol defined doses. |
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| Treatment Group 4 | Active Comparator | Moxifloxacin will be administered at the protocol defined doses. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Povorcitinib | Drug | Povorcitinib will be administered at protocol defined dose. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in QT interval corrected using Fridericia's formula (QTcF) | Electrocardiogram measurement of the maximum absolute change from baseline in Fridericia's correction for QT interval (QTcF) | Up to Day 3 |
| Change from Baseline in heart rate (HR) | Electrocardiogram measurement of change from baseline in HR. | Up to Day 3 |
| Change from Baseline in the PR Interval (PR) | Electrocardiogram measurement of change from baseline in PR. | Up to Day 3 |
| Change from Baseline in the QRS interval (QRS) | Electrocardiogram measurement of change from baseline in QRS. | Up to Day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability as measured by the frequency, duration, and severity of adverse events (AEs) | An AE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurs after a subject provides informed consent. | Up to Day 22 |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined Inclusion/Exclusion Criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Incyte Medical Monitor | Incyte Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion Clinical Research Unit | Tempe | Arizona | 85253 | 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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| Placebo | Drug | Placebo will be administered at protocol defined dose. |
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| Moxifloxacin | Drug | Moxifloxacin will be administered at protocol defined dose. |
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| Povorcitinib concentration in plasma |
Povorcitinib concentration in plasma. |
| Up to Day 7 |
| Moxifloxacin concentration in plasma | Moxifloxacin concentration in plasma. | Up to Day 7 |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |