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

NCT07814404 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: INCB161734-102
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Healthy Participants

Keywords

INCB161734

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (16)

• PK for plasma INCB123667: Cmax

  Up to 2 weeks

• PK for plasma INCB123667: tmax

  Up to 2 weeks

• PK for plasma INCB123667: AUClast

  Up to 2 weeks

• PK for plasma INCB123667: AUCinf

  Up to 2 weeks

• PK for plasma INCB123667: t½

  Up to 2 weeks

Study Arms (1)

INCB161734

EXPERIMENTAL

Participants will be administered orally a dose solution consisting of INCB161734 and radiolabeled INCB161734.

Drug: INCB161734

Interventions

INCB161734 DRUG

Participants will be administered orally a dose solution consisting of INCB161734 and radiolabeled INCB161734.

INCB161734

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Incyte Corporation: lead

Related Links

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

Study Officials

• Incyte Medical Monitor

  Incyte Corporation

  STUDY DIRECTOR

Central Study Contacts

Incyte Corporation Call Center (US)

CONTACT

1.855.463.3463; medinfo@incyte.com

Incyte Corporation Call Center (ex-US)

CONTACT

+800 00027423; eumedinfo@incyte.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2026
• First Posted: September 11, 2026
• Study Start: September 18, 2026
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): October 15, 2026
• Last Updated: September 17, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share