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

September 4, 2026 updated by: Incyte Corporation

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Total Recovery (Urine + Feces) of the Administered Radioactivity
Time Frame: Up to 2 weeks
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
Time Frame: Up to 2 weeks
To characterize the metabolic profile and identify circulating and excreted metabolites of INCB161734.
Up to 2 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Treatment Emergent Adverse Events (TEAEs)
Time Frame: Up to approximately 2 months
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
Time Frame: Up to 2 weeks
Defined as the maximum plasma concentration.
Up to 2 weeks
PK for plasma INCB123667: tmax
Time Frame: Up to 2 weeks
Defined as the time to reach maximum concentration.
Up to 2 weeks
PK for plasma INCB123667: AUClast
Time Frame: Up to 2 weeks
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
Time Frame: Up to 2 weeks
Defined as area under the concentration-time profile extrapolated to time of infinity.
Up to 2 weeks
PK for plasma INCB123667: t½
Time Frame: Up to 2 weeks
Defined as terminal-phase half-life.
Up to 2 weeks
PK for plasma INCB123667: CL/F
Time Frame: Up to 2 weeks
Defined as apparent clearance.
Up to 2 weeks
PK for plasma INCB123667: Vz/F
Time Frame: Up to 2 weeks
Defined as apparent volume of distribution.
Up to 2 weeks
PK for urine INCB123667: Ae
Time Frame: Up to 2 weeks
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
Time Frame: Up to 2 weeks
Defined as renal clearance.
Up to 2 weeks
PK for urine INCB123667: %fe
Time Frame: Up to 2 weeks
Defined as fraction of drug excreted unchanged in urine.
Up to 2 weeks
PK for whole blood and plasma total radioactivity: Cmax
Time Frame: Up to 2 weeks
Defined as the maximum plasma concentration.
Up to 2 weeks
PK for whole blood and plasma total radioactivity: tmax
Time Frame: Up to 2 weeks
Defined as the time to reach maximum concentration.
Up to 2 weeks
PK for whole blood and plasma total radioactivity: AUClast
Time Frame: Up to 2 weeks
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
Time Frame: Up to 2 weeks
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
Time Frame: Up to 2 weeks
Defined as terminal-phase half-life.
Up to 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Incyte Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Incyte Medical Monitor, Incyte Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 18, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 15, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 15, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 4, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 4, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 11, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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