A Study to Assess the Mass Balance, Pharmacokinetics, and Metabolite Profiles of a Single Oral Dose of [14C]-INCB161734 in Healthy Male Participants

An Open-Label Study Assessing the Mass Balance, Pharmacokinetics, and Metabolite Profiles of a Single Oral Dose of [14C]-INCB161734 in Healthy Male Participants

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 Overview

• Status: Not yet recruiting
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: INCB161734

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Incyte Corporation Call Center (US); Phone Number: 1.855.463.3463; Email: medinfo@incyte.com
• Study Contact Backup: Name: Incyte Corporation Call Center (ex-US); Phone Number: +800 00027423; Email: eumedinfo@incyte.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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).
• History of irregular bowel movements (eg, irritable bowel syndrome, frequent episodes of diarrhea, or constipation defined by less than 1 bowel movement on average per 2 days) or lactose intolerant.
• History of malignancy within 5 years of screening, with the exception of cured basal cell or squamous cell carcinoma of the skin, ductal carcinoma in situ, or prostate cancer.
• Current or recent (≤ 6 months of screening), clinically significant gastrointestinal disease or surgery or any history of gastrointestinal surgery (including cholecystectomy, excluding appendectomy and uncomplicated hernia repair) that is anticipated to affect the absorption of study treatment.
• Any major surgery within ≤ 6 months of screening.
• Donation of blood to a blood bank within 4 weeks of screening (within 2 weeks for plasma only).
• Blood transfusion within 4 weeks of check-in.

• Positive test for hepatitis B virus, HCV, or HIV.

  • Note: Participants whose results are compatible with prior immunization or immunity due to infection for hepatitis B may be included at the discretion of the investigator.

• History of significant alcohol use within 3 months of screening, defined as regular alcohol consumption > 21 units per week (1 unit = ½ pint beer or a 25-mL shot of 40% spirit, 1.5 to 2 units = 125-mL glass of wine, depending on type).
• Positive urine or breath test for ethanol or positive urine or serum screen for drugs of abuse that are not otherwise explained by permitted concomitant medications or diet.
• Exposure to significant diagnostic or therapeutic radiation (eg, serial x-ray, computed tomography scan, barium meal) or employment in a job requiring radiation exposure monitoring within 12 months prior to check-in.
• History of any significant drug allergy (such as anaphylaxis or hepatotoxicity) deemed clinically relevant by the investigator.
• Known hypersensitivity or severe reaction to INCB161734 or any excipients of INCB161734 (refer to the IB).
• Use of tobacco- or nicotine-containing products within 1 month of screening.
• eGFR < 90 mL/min/1.73 m2 based on the site's preferred formula at screening. • Note: Assessment of eGFR may be repeated once if outside of the reference range.

Other protocol-defined Inclusion/Exclusion Criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: INCB161734; Participants will be administered orally a dose solution consisting of INCB161734 and radiolabeled INCB161734.	Drug: INCB161734; Participants will be administered orally a dose solution consisting of INCB161734 and radiolabeled INCB161734.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.	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.	Up to 2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
PK for plasma INCB123667: Cmax	Defined as the maximum plasma concentration.	Up to 2 weeks
PK for plasma INCB123667: tmax	Defined as the time to reach maximum concentration.	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).	Up to 2 weeks
PK for plasma INCB123667: AUCinf	Defined as area under the concentration-time profile extrapolated to time of infinity.	Up to 2 weeks
PK for plasma INCB123667: t½	Defined as terminal-phase half-life.	Up to 2 weeks
PK for plasma INCB123667: CL/F	Defined as apparent clearance.	Up to 2 weeks
PK for plasma INCB123667: Vz/F	Defined as apparent volume of distribution.	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.	Up to 2 weeks
PK for urine INCB123667: CLR	Defined as renal clearance.	Up to 2 weeks
PK for urine INCB123667: %fe	Defined as fraction of drug excreted unchanged in urine.	Up to 2 weeks
PK for whole blood and plasma total radioactivity: Cmax	Defined as the maximum plasma concentration.	Up to 2 weeks
PK for whole blood and plasma total radioactivity: tmax	Defined as the time to reach maximum concentration.	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).	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.	Up to 2 weeks
PK for whole blood and plasma total radioactivity: t½	Defined as terminal-phase half-life.	Up to 2 weeks

Collaborators and Investigators

• Sponsor: Incyte Corporation
• Investigators: Study Director: Incyte Medical Monitor, Incyte Corporation

Study record dates

Study Major Dates

• Study Start (Estimated): September 18, 2026
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): October 15, 2026

Study Registration Dates

• First Submitted: September 4, 2026
• First Submitted That Met QC Criteria: September 4, 2026
• First Posted (Actual): September 11, 2026

Study Record Updates

• Last Update Posted (Actual): September 11, 2026
• Last Update Submitted That Met QC Criteria: September 4, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: INCB161734
• Other Study ID Numbers: INCB161734-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No