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The purpose of this study is to evaluate the Relative Bioavailability of New Formulations of INCB057643 Tablets Administered Orally in Healthy Participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Dose Treatment A | Experimental | INCB057643 will be administered at protocol defined dose. |
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| Cohort 2: Dose Treatment B | Experimental | INCB057643 will be administered at protocol defined dose. |
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| Cohort 3: Dose Treatment C | Experimental | INCB057643 will be administered at protocol defined dose. |
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| Cohort 4: Dose Treatment D | Experimental | INCB057643 will be administered at protocol defined dose. |
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| Cohort 4: Dose Treatment E | Experimental | INCB057643 will be administered at protocol defined dose. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INCB057643 | Drug | Tablet |
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| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics Parameter (PK): Cmax of INCB057643 | Defined as maximum observed plasma concentration of INCB057643. | Up to Day 10 |
| Pharmacokinetics Parameter: AUC(0-last) of INCB057643 | Defined as area under the single-dose serum concentration-time curve from time = 0 to the last measurable concentration at time of INCB057643. | Up to Day 10 |
| Pharmacokinetics Parameter: AUC 0-∞ of INCB057643 | Defined as the area under the single-dose serum concentration-time curve extrapolated to time of infinity of INCB057643. | Up to Day 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Treatment-emergent Adverse Events (TEAEs) | Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug. | Up to Day 26 |
| Pharmacokinetics Parameter: Tmax of INCB057643 |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined Inclusion/Exclusion Criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Incyte Study Monitor | Incyte Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion, Inc | Tempe | Arizona | 85283 | United States |
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| Label | URL |
|---|---|
| A Study to Evaluate the Relative Bioavailability of New Formulations of INCB057643 Tablets Administered Orally in Healthy Participants | View source |
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| ID | Term |
|---|---|
| C000712522 | INCB057643 |
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Cohorts 1-3 are single dose, and Cohort 4 is single dose, 2-way crossover.
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Defined as the time to reach the maximum plasma concentration of INCB057643. |
| Up to Day 10 |
| Pharmacokinetics Parameter: t1/2 of INCB057643 | Defined as the apparent terminal phase disposition half-life of INCB057643. | Up to Day 10 |
| Pharmacokinetics Parameter: CL/F INCB057643 | Defined as the apparent oral dose clearance of INCB057643. | Up to Day 10 |
| Pharmacokinetics Parameter: V2/F of INCB057643 | Defined as the apparent oral dose volume of distribution of INCB057643. | Up to Day 10 |
| Pharmacokinetics Parameter: λz of INCB057643 | Defined as apparent terminal-phase disposition rate constant of INCB057643. | Up to Day 10 |
| Pharmacokinetics Parameter: %AUCexp of INCB057643 | Defined as percentage of AUC0-∞ due to extrapolation from the time of last quantifiable concentration to infinity of INCB057643. | Up to Day 10 |