This study will assess the mass balance, pharmacokinetics, and metabolite profiles of a single oral dose of \[14C\] INCB123667 in healthy male participants.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
INCB123667 will be administered orally as a tablet dose, followed approximately 10 minutes later by an oral dose solution of radiolabeled INCB123667.
Fortrea Clinical Research Unit Ltd Labcorp Clinical Research Unit Limited Madison
Madison, Wisconsin, United States
Total Recovery (Urine + Feces) of the Administered Radioactivity
Radioactivity in urine and feces was reported as the percentage of the administered radioactivity excreted.
Time frame: 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.
Time frame: Up to approximately 2 months
PK for plasma INCB123667: Cmax
Defined as the maximum plasma concentration.
Time frame: Up to approximately 2 months
PK for plasma INCB123667: tmax
Defined as the time to reach maximum concentration.
Time frame: 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).
Time frame: Up to approximately 2 months
PK for plasma INCB123667: AUCinf
Defined as area under the concentration-time profile extrapolated to time of infinity.
Time frame: Up to approximately 2 months
PK for plasma INCB123667: t½
Defined as terminal-phase half-life.
Time frame: Up to approximately 2 months
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PK for plasma INCB123667: CL/F
Defined as apparent clearance.
Time frame: Up to approximately 2 months
PK for plasma INCB123667: Vz/F
Defined as apparent volume of distribution.
Time frame: Up to approximately 2 months
PK for whole blood and plasma total radioactivity: Cmax
Defined as the maximum plasma concentration.
Time frame: Up to approximately 2 months
PK for whole blood and plasma total radioactivity: tmax
Defined as the time to reach maximum concentration.
Time frame: Up to approximately 2 months
PK for whole blood and plasma total radioactivity: t½
Defined as terminal-phase half-life.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: Up to approximately 2 months