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This study will be conducted to evaluate the effect of food on the single-dose pharmacokinetics and a drug-drug interaction evaluation of itraconazole and carbamazepine on INCB123667 when administered orally to healthy adult participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Treatment A - INCB123667 Fasted | Experimental | INCB123667 will be administered at the protocol defined dose. |
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| Cohort 1: Treatment B - INCB123667 Fed | Experimental | INCB123667 will be administered at the protocol defined dose. |
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| Cohort 2: INCB123667 and itraconazole | Experimental | INCB123667 and itraconazole will be administered at protocol defined doses. |
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| Cohort 3: INCB123667 and carbamazepine | Experimental | INCB123667 and carbamazepine will be administered at protocol defined doses. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INCB123667 | Drug | single dose administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics Parameter (PK): Cmax of INCB123667 | Defined as the maximum observed plasma or serum concentration. | Up to Day 16 |
| Pharmacokinetics Parameter: Tmax of INCB123667 | Defined as the time to maximum concentration. | Up to Day 16 |
| Pharmacokinetics Parameter: AUCt of INCB123667 | Defined as the area under the steady-state plasma or serum concentration-time curve from time = 0 to the last measurable concentration at time = t. | Up to Day 16 |
| Pharmacokinetics Parameter: AUC∞ of INCB123667 | Defined as the area under the single-dose plasma or serum concentration-time curve extrapolated to time of infinity. | Up to Day 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Treatment-emergent Adverse Events (TEAEs) | Defined as AEs reported for the first time or worsening of a pre-existing event after the first dose of study treatment. | Up to Day 45 |
| Pharmacokinetics Parameter: tmax of INCB123667 |
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Inclusion Criteria:
Ability to comprehend and willingness to sign a written ICF for the study.
Age 19 (in compliance with Nebraska state law) to 55 years, inclusive, at the time of signing the ICF.
Body mass index between 18.0 and 32.0 kg/m2, inclusive, at screening. Note: Only up to 25% of the participants may be enrolled with a BMI > 30 to ≤ 32.0 kg/m2.
No clinically significant findings on screening evaluations (clinical, laboratory results [with the exception of lipids], and ECGs).
Ability to swallow and retain oral tablets.
Willingness to avoid pregnancy or fathering children based on the criteria below:
Exclusion Criteria:
NOTE: Assessment of eGFR may be repeated once if outside of the reference range.
Note: No vaccines of any type may be administered within 3 months prior to the first dose of study treatment.
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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 |
|---|---|
| A Study to Evaluate the Effect of Food on the Single-Dose Pharmacokinetics of INCB123667 When Administered Orally to Healthy Adult Participants | View source |
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| itraconazole | Drug | Oral: Tablet |
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| carbamazepine | Drug | Oral; Tablet |
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Defined as the time to maximum concentration. |
| Up to Day 16 |
| Pharmacokinetics Parameter: t½ of INCB123667 | Defined as the apparent terminal-phase disposition half-life. | Up to Day 16 |
| Pharmacokinetics Parameter: CL/F of INCB123667 | Defined as the apparent oral dose clearance. | Up to Day 16 |
| Pharmacokinetics Parameter: Vz/F of INCB123667 | Defined as the apparent oral dose volume of distribution. | Up to Day 16 |
| ID | Term |
|---|---|
| D017964 | Itraconazole |
| D002220 | Carbamazepine |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010879 | Piperazines |
| D003984 | Dibenzazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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