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This study will assess the mass balance, pharmacokinetics, and metabolite profiles of a single oral dose of [14C] INCB123667 in healthy male participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment: INCB123667 | Experimental | Participants will be administered INCB123667 tablet orally, followed approximately 10 minutes later by an oral dose solution of radiolabeled INCB123667. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INCB123667 | Drug | INCB123667 will be administered orally as a tablet dose, followed approximately 10 minutes later by an oral dose solution of radiolabeled INCB123667. |
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| Measure | Description | Time Frame |
|---|---|---|
| Total Recovery (Urine + Feces) of the Administered Radioactivity | Radioactivity in urine and feces was reported as the percentage of the administered radioactivity excreted. | Approximately 2 weeks |
| Percentage of total radioactive dose in Plasma, Urinary and Fecal Excretion | To characterize the metabolic profile and identify circulating and excreted metabolites of INCB123667 following administration of a single oral dose of INCB123667 followed by an oral dose solution of [14C]-INCB123667 using liquid chromatography with mass spectral detection. | Up to approximately 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| PK for plasma INCB123667: Cmax | Defined as the maximum plasma concentration. | Up to approximately 2 months |
| PK for plasma INCB123667: tmax | Defined as the time to reach maximum concentration. |
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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 |
|---|---|---|---|---|---|---|
| Fortrea Clinical Research Unit Ltd Labcorp Clinical Research Unit Limited Madison | Madison | Wisconsin | 53704 | United States |
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| Label | URL |
|---|---|
| Study Assessing the Mass Balance, Pharmacokinetics, and Metabolite Profiles of a Single Oral Dose of \[14C\]-INCB123667 in Healthy Male Participants | View source |
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| Up to approximately 2 months |
| PK for plasma INCB123667: AUClast | Defined as area under the concentration-time profile from time zero to time of the last quantifiable concentration (Clast). | Up to approximately 2 months |
| PK for plasma INCB123667: AUCinf | Defined as area under the concentration-time profile extrapolated to time of infinity. | Up to approximately 2 months |
| PK for plasma INCB123667: t½ | Defined as terminal-phase half-life. | Up to approximately 2 months |
| PK for plasma INCB123667: CL/F | Defined as apparent clearance. | Up to approximately 2 months |
| PK for plasma INCB123667: Vz/F | Defined as apparent volume of distribution. | Up to approximately 2 months |
| PK for whole blood and plasma total radioactivity: Cmax | Defined as the maximum plasma concentration. | Up to approximately 2 months |
| PK for whole blood and plasma total radioactivity: tmax | Defined as the time to reach maximum concentration. | Up to approximately 2 months |
| PK for whole blood and plasma total radioactivity: t½ | Defined as terminal-phase half-life. | Up to approximately 2 months |
| PK for whole blood and plasma total radioactivity: AUClast | Defined as area under the concentration-time profile from time zero to time of the last quantifiable concentration (Clast). | Up to approximately 2 months |
| PK for whole blood and plasma total radioactivity: AUCinf | Defined as area under the concentration-time profile extrapolated to time of infinity. | Up to approximately 2 months |
| Treatment Emergent Adverse Events (TEAEs) | Adverse events reported for the first time or worsening of a pre-existing event, occurring after study treatment administration. | Up to approximately 2 months |