Healthy ParticipantsPhase 1NCT07814404
A Study to Assess the Mass Balance, Pharmacokinetics, and Metabolite Profiles of a Single Oral Dose of [14C]-INCB161734 in Healthy Male Participants
A Phase 1 study testing INCB161734 in people with Healthy Participants, run by Incyte Corporation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- INCB161734
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2026to 15 Oct 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 20Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Healthy Participants
- Being tested
- INCB161734
- Keywords
- INCB161734
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INCB161734Drug
Participants will be administered orally a dose solution consisting of INCB161734 and radiolabeled INCB161734.
| Study group | Role | What they receive |
|---|---|---|
| INCB161734 | Experimental | Participants will be administered orally a dose solution consisting of INCB161734 and radiolabeled INCB161734. Receives: Drug: INCB161734 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Recovery (Urine + Feces) of the Administered Radioactivity
Radioactivity in urine and feces was reported as the percentage of the administered radioactivity excreted.
Measured: 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.
Measured: Up to 2 weeks
Secondary outcomes (16)
PK for plasma INCB123667: Cmax
Defined as the maximum plasma concentration.
Measured: Up to 2 weeks
PK for plasma INCB123667: tmax
Defined as the time to reach maximum concentration.
Measured: 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).
Measured: Up to 2 weeks
PK for plasma INCB123667: AUCinf
Defined as area under the concentration-time profile extrapolated to time of infinity.
Measured: Up to 2 weeks
PK for plasma INCB123667: t½
Defined as terminal-phase half-life.
Measured: Up to 2 weeks
PK for plasma INCB123667: CL/F
Defined as apparent clearance.
Measured: Up to 2 weeks
PK for plasma INCB123667: Vz/F
Defined as apparent volume of distribution.
Measured: 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.
Measured: Up to 2 weeks
PK for urine INCB123667: CLR
Defined as renal clearance.
Measured: Up to 2 weeks
PK for urine INCB123667: %fe
Defined as fraction of drug excreted unchanged in urine.
Measured: Up to 2 weeks
PK for whole blood and plasma total radioactivity: Cmax
Defined as the maximum plasma concentration.
Measured: Up to 2 weeks
PK for whole blood and plasma total radioactivity: tmax
Defined as the time to reach maximum concentration.
Measured: 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).
Measured: 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.
Measured: Up to 2 weeks
PK for whole blood and plasma total radioactivity: t½
Defined as terminal-phase half-life.
Measured: 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.
Measured: Up to approximately 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study start18 Sep 2026
- Primary completion15 Oct 2026
- Study completion15 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by Incyte CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Incyte Medical Monitor, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07814404
- Sponsor's protocol ID
- INCB161734-102
- Status last verified
- Nov 2026
- First submitted
- 4 Sep 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study Assessing the Mass Balance, Pharmacokinetics, and Metabolite Profiles of a Single Oral Dose of [14C]-INCB161734 in Healthy Male Participants
- ClinicalTrials.gov ID
- NCT07814404
- Acronym / sponsor ID
- INCB161734-102
- Conditions
- Healthy Participants
- Keywords
- INCB161734
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 18 Sep 2026 (actual)
- Primary completion
- 15 Oct 2026 (actual)
- Study completion
- 15 Oct 2026 (actual)
- First posted
- 11 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| INCB161734 | Experimental | Drug: INCB161734Participants will be administered orally a dose solution consisting of INCB161734 and radiolabeled INCB161734. |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INCB161734Participants will be administered orally a dose solution consisting of INCB161734 and radiolabeled INCB161734. | Drug | INCB161734 |
Primary outcome
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.
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.
16 secondary outcomes
PK for plasma INCB123667: Cmax
Time frame: Up to 2 weeks
PK for plasma INCB123667: tmax
Time frame: Up to 2 weeks
PK for plasma INCB123667: AUClast
Time frame: Up to 2 weeks
PK for plasma INCB123667: AUCinf
Time frame: Up to 2 weeks
PK for plasma INCB123667: t½
Time frame: Up to 2 weeks
PK for plasma INCB123667: CL/F
Time frame: Up to 2 weeks
PK for plasma INCB123667: Vz/F
Time frame: Up to 2 weeks
PK for urine INCB123667: Ae
Time frame: Up to 2 weeks
PK for urine INCB123667: CLR
Time frame: Up to 2 weeks
PK for urine INCB123667: %fe
Time frame: Up to 2 weeks
PK for whole blood and plasma total radioactivity: Cmax
Time frame: Up to 2 weeks
PK for whole blood and plasma total radioactivity: tmax
Time frame: Up to 2 weeks
PK for whole blood and plasma total radioactivity: AUClast
Time frame: Up to 2 weeks
PK for whole blood and plasma total radioactivity: AUCinf
Time frame: Up to 2 weeks
PK for whole blood and plasma total radioactivity: t½
Time frame: Up to 2 weeks
Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to approximately 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- A Study to Assess the Mass Balance, Pharmacokinetics, and Metabolite Profiles of a Single Oral Dose of \[14C\]-INCB161734 in Healthy Male ParticipantsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Incyte Medical Monitor study director
Incyte Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing INCB161734 in people with Healthy Participants, run by Incyte Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Recovery (Urine + Feces) of the Administered Radioactivity (time frame: Up to 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.