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This study will be conducted to assess the Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics, and Food Effect of INCB000631 When Administered Orally to Healthy Adult Participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A | Experimental | INCB000631 or placebo will be administered at the protocol defined dose. |
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| Cohort B | Experimental | INCB000631 or placebo will be administered at the protocol defined dose. |
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| Cohort C | Experimental | INCB000631 or placebo will be administered at the protocol defined dose. |
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| Cohort D | Experimental | INCB000631 or placebo will be administered at the protocol defined dose. |
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| Cohort E | Experimental | INCB000631 or placebo will be administered at the protocol defined dose. |
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| Optional Cohort F | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INCB000631 | Drug | Oral; Tablet |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Treatment-emergent Adverse Events (TEAEs) | Defined as any adverse event, either reported for the first time or the worsening of a pre-existing event, occurring after dose of study treatment. | Up to Day 41 |
| PK for plasma INCB000631: Cmax | Maximum Observed Plasma Concentration of INCB000631. | Up to Day 14 |
| PK for plasma INCB000631: tmax | Time to maximum plasma concentration of INCB000631. | Up to Day 14 |
| PK for plasma INCB000631: AUC(0-t) | Area under the single-dose plasma concentration-time curve up to the last measurable plasma concentration of INCB000631. | Up to Day 14 |
| PK for plasma INCB000631: AUC 0-∞ | Area under the single-dose plasma concentration-time curve from 0 to Infinity of INCB000631. | Up to Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| PK for plasma INCB000631: t1/2 | Apparent terminal phase disposition half-life of INCB000631. | Up to Day 14 |
| PK for plasma INCB000631: CL/F | Dose clearance of INCB000631. |
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Inclusion Criteria:
Exclusion Criteria:
In the event a value is exclusionary, a single ECG will be repeated twice, and an average of the 3 readings will be used to determine if a participant should be excluded.
Note: Examples of live vaccines include but are not limited to the following: measles, mumps, rubella, chickenpox/zoster, yellow fever, rabies, Bacillus Calmette-Guérin, and typhoid.
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| Name | Affiliation | Role |
|---|---|---|
| Incyte Medical Monitor | Incyte Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion, Inc | Lincoln | Nebraska | 68502 | United States |
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| Label | URL |
|---|---|
| Study to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, \& Food Effect of Oral INCB000631 to Healthy Adult Participants | View source |
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INCB000631 or placebo will be administered at the protocol defined dose.
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| Cohort G Treatment A | Experimental | INCB000631 will be administered at the protocol defined dose. |
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| Cohort G Treatment B | Experimental | INCB000631 will be administered at the protocol defined dose. |
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| Placebo | Drug | Oral; Tablet |
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| Up to Day 14 |
| PK for plasma INCB000631: Vz/F | Apparent oral dose volume of distribution of INCB000631. | Up to Day 14 |
| PK for plasma INCB000631: λz | Apparent terminal-phase disposition rate constant of INCB000631. | Up to Day 14 |
| PK for urine INCB000631: Ae96h | Amount of INCB000631 excreted in the urine over 96 hours. | Up to Day 14 |
| PK for urine INCB000631: fe | Percent of INCB000631 excreted in the urine. | Up to Day 14 |
| PK for urine INCB000631: CLR | Renal clearance of INCB000631. | Up to Day 14 |