This study is conducted to assess the mass balance, pharmacokinetics, and metabolite profiles of a single oral dose of \[14C\]-INCB161734 in healthy male participants.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Participants will be administered orally a dose solution consisting of INCB161734 and radiolabeled INCB161734.
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: Up to 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 INCB161734.
Time frame: Up to 2 weeks
PK for plasma INCB123667: Cmax
Defined as the maximum plasma concentration.
Time frame: Up to 2 weeks
PK for plasma INCB123667: tmax
Defined as the time to reach maximum concentration.
Time frame: Up to 2 weeks
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 2 weeks
PK for plasma INCB123667: AUCinf
Defined as area under the concentration-time profile extrapolated to time of infinity.
Time frame: Up to 2 weeks
PK for plasma INCB123667: t½
Defined as terminal-phase half-life.
Time frame: Up to 2 weeks
PK for plasma INCB123667: CL/F
Defined as apparent clearance.
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Time frame: Up to 2 weeks
PK for plasma INCB123667: Vz/F
Defined as apparent volume of distribution.
Time frame: Up to 2 weeks
PK for urine INCB123667: Ae
Defined as cumulative amount of drug excreted unchanged in the urine for the entire sampling period.
Time frame: Up to 2 weeks
PK for urine INCB123667: CLR
Defined as renal clearance.
Time frame: Up to 2 weeks
PK for urine INCB123667: %fe
Defined as fraction of drug excreted unchanged in urine.
Time frame: Up to 2 weeks
PK for whole blood and plasma total radioactivity: Cmax
Defined as the maximum plasma concentration.
Time frame: Up to 2 weeks
PK for whole blood and plasma total radioactivity: tmax
Defined as the time to reach maximum concentration.
Time frame: Up to 2 weeks
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 2 weeks
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 2 weeks
PK for whole blood and plasma total radioactivity: t½
Defined as terminal-phase half-life.
Time frame: Up to 2 weeks
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