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.
Healthy males aged 19 to 55 years (inclusive) at the time of signing the ICF.
Body mass index between 18.0 and 32.0 kg/m2 (inclusive).
Ability to swallow and retain oral medication.
History of uncontrolled or unstable cardiovascular, respiratory, renal, gastrointestinal, endocrine, hematopoietic, psychiatric, and/or neurological disease within 6 months of screening.
Resting pulse < 40 bpm or > 100 bpm, confirmed by repeat testing at screening.
History or presence of an abnormal ECG before initial dose administration that, in the investigator's opinion, is clinically significant (QTcF interval > 450 milliseconds [may increase the risk associated with participating in the study or may confound ECG data analysis], QRS interval > 120 milliseconds, and PR interval > 220 milliseconds).
Presence of a malabsorption syndrome possibly affecting drug absorption (eg, Crohn disease or chronic pancreatitis).
Single group
INCB161734
DrugParticipants 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.
Percentage of total radioactive dose in Plasma, Urinary and Fecal Excretion
To characterize the metabolic profile and identify circulating and excreted metabolites of INCB161734.
PK for plasma INCB123667: Cmax
Defined as the maximum plasma concentration.
PK for plasma INCB123667: tmax
Defined as the time to reach maximum concentration.
PK for plasma INCB123667: AUClast
Defined as area under the concentration-time profile from time zero to time of the last quantifiable concentration (Clast).
PK for plasma INCB123667: AUCinf
Defined as area under the concentration-time profile extrapolated to time of infinity.
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