Healthy ParticipantsPhase 1NCT07218744
Study Assessing the Mass Balance, Pharmacokinetics, and Metabolite Profiles of a Single Oral Dose of [14C]-INCB123667 in Healthy Male Participants
A Phase 1 study testing INCB123667 in people with Healthy Participants, run by Incyte Corporation at 1 site in United States.
Trial summary
This study will assess the mass balance, pharmacokinetics, and metabolite profiles of a single oral dose of [14C] INCB123667 in healthy male participants. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- INCB123667
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Nov 2025to 10 Dec 2025
- 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 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ability to comprehend and willingness to sign a written ICF for the study.
- Healthy males age 18 to 55 years, inclusive, at the time of signing the ICF.
- Body mass index between 18.0 and 32.0 kg/m2, inclusive, at the time of screening.
- No clinically significant findings in screening evaluations (eg, clinical, laboratory, vital signs, ECG). Tests with results that fail eligibility requirements may be repeated once during screening if the investigator believes the results to be in error.
- Ability to swallow and retain oral medication.
Who cannot join
- History of clinically significant respiratory, renal, GI, endocrine, hematopoietic, psychiatric, and/or neurological disease.
- History of cardiovascular, cerebrovascular, peripheral vascular, or thrombotic disease or uncontrolled hypertension (systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg at screening, confirmed by repeat testing).
- Presence of a malabsorption syndrome (eg, Crohn's disease or chronic pancreatitis) that could possibly affect drug absorption.
- Current or recent (≤ 6 months of screening), clinically significant gastrointestinal disease or surgery or any history of GI surgery (including cholecystectomy, excluding appendectomy and uncomplicated hernia repair) that is anticipated to affect the absorption of the study drug.
- Any major surgery within 6 months (≤ 6 months) of screening.
- Donation of blood to a blood bank or participation in a clinical study (except a screening visit) within 4 weeks of screening (within 2 weeks for donation of plasma only).
Show all 15Show fewer
- Positive test for HBV, HCV, or HIV. Participants whose HBV results are compatible with prior immunization or immunity due to infection 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 for males (1 unit = 0.5 pint of 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 result for ethanol or positive urine or serum screen for drugs of abuse that are not otherwise explained by permitted concomitant medications or diet.
- Current treatment or treatments within 30 days or 5 half-lives (whichever is longer) before the first dose of study drug on Day 1 with another investigational medication, or current enrollment in another investigational drug study.
- Participation in more than 3 radiolabeled drug studies in the last 12 months (previous study in which exposures are known to the investigator to be at least 4 months prior to check-in [Day -1]; previous studies in which exposures are not known to the investigator to be at least 6 months prior to check-in [Day -1]).
- 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.
- Current treatment or treatment within 15 days or 5 half-lives (whichever is longer) before the first dose of study drug with any medications known to be an inducer or potent inhibitor of CYP3A4, BCRP, or P-gp (refer to the Certara Drug Interaction Database Program for prohibited medications).
- History of tobacco- or nicotine-containing product use within 1 month of screening. However, use of nicotine-containing products that is equivalent to ≤ 2 cigarettes per week may be permitted at the discretion of the investigator.
- Other protocol-defined Inclusion/Exclusion Criteria may apply.
Trial locations and contacts
1 site in 1 country.
United States1 site
Fortrea Clinical Research Unit Ltd Labcorp Clinical Research Unit Limited Madison
Madison, Wisconsin, 53704
About this study
Official title: An Open-Label Study Assessing the Mass Balance, Pharmacokinetics, and Metabolite Profiles of a Single Oral Dose of [14C]-INCB123667 in Healthy Male Participants
This study will assess the mass balance, pharmacokinetics, and metabolite profiles of a single oral dose of [14C] INCB123667 in healthy male participants.
- Conditions
- Healthy Participants
- Being tested
- INCB123667
- Keywords
- INCB123667
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INCB123667Drug
INCB123667 will be administered orally as a tablet dose, followed approximately 10 minutes later by an oral dose solution of radiolabeled INCB123667.
| Study group | Role | What they receive |
|---|---|---|
| Treatment: INCB123667 | Experimental | Participants will be administered INCB123667 tablet orally, followed approximately 10 minutes later by an oral dose solution of radiolabeled INCB123667. Receives: Drug: INCB123667 |
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: Approximately 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 INCB123667 following administration of a single oral dose of INCB123667 followed by an oral dose solution of [14C]-INCB123667 using liquid chromatography with mass spectral detection.
Measured: Up to approximately 2 months
Secondary outcomes (13)
PK for plasma INCB123667: Cmax
Defined as the maximum plasma concentration.
Measured: Up to approximately 2 months
PK for plasma INCB123667: tmax
Defined as the time to reach maximum concentration.
Measured: Up to approximately 2 months
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 approximately 2 months
PK for plasma INCB123667: AUCinf
Defined as area under the concentration-time profile extrapolated to time of infinity.
Measured: Up to approximately 2 months
PK for plasma INCB123667: t½
Defined as terminal-phase half-life.
Measured: Up to approximately 2 months
PK for plasma INCB123667: CL/F
Defined as apparent clearance.
Measured: Up to approximately 2 months
PK for plasma INCB123667: Vz/F
Defined as apparent volume of distribution.
Measured: Up to approximately 2 months
PK for whole blood and plasma total radioactivity: Cmax
Defined as the maximum plasma concentration.
Measured: Up to approximately 2 months
PK for whole blood and plasma total radioactivity: tmax
Defined as the time to reach maximum concentration.
Measured: Up to approximately 2 months
PK for whole blood and plasma total radioactivity: t½
Defined as terminal-phase half-life.
Measured: Up to approximately 2 months
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 approximately 2 months
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 approximately 2 months
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 posted20 Oct 2025
- Study start13 Nov 2025
- Primary completion10 Dec 2025
- Study completion10 Dec 2025
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
- 9 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
- NCT07218744
- Sponsor's protocol ID
- INCB123667-103
- Status last verified
- Jan 2026
- First submitted
- 16 Oct 2025
- Last updated
- 7 Jan 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 7 Jan 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]-INCB123667 in Healthy Male Participants
- ClinicalTrials.gov ID
- NCT07218744
- Acronym / sponsor ID
- INCB123667-103
- Conditions
- Healthy Participants
- Keywords
- INCB123667
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 13 Nov 2025 (actual)
- Primary completion
- 10 Dec 2025 (actual)
- Study completion
- 10 Dec 2025 (actual)
- First posted
- 20 Oct 2025 (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 will assess the mass balance, pharmacokinetics, and metabolite profiles of a single oral dose of [14C] INCB123667 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 |
|---|---|---|
| Treatment: INCB123667 | Experimental | Drug: INCB123667Participants will be administered INCB123667 tablet orally, followed approximately 10 minutes later by an oral dose solution of radiolabeled INCB123667. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Ability to comprehend and willingness to sign a written ICF for the study.
- Healthy males age 18 to 55 years, inclusive, at the time of signing the ICF.
- Body mass index between 18.0 and 32.0 kg/m2, inclusive, at the time of screening.
- No clinically significant findings in screening evaluations (eg, clinical, laboratory, vital signs, ECG). Tests with results that fail eligibility requirements may be repeated once during screening if the investigator believes the results to be in error.
- Ability to swallow and retain oral medication.
Key exclusion criteria (15 listed)
- History of clinically significant respiratory, renal, GI, endocrine, hematopoietic, psychiatric, and/or neurological disease.
- History of cardiovascular, cerebrovascular, peripheral vascular, or thrombotic disease or uncontrolled hypertension (systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg at screening, confirmed by repeat testing).
- Presence of a malabsorption syndrome (eg, Crohn's disease or chronic pancreatitis) that could possibly affect drug absorption.
- Current or recent (≤ 6 months of screening), clinically significant gastrointestinal disease or surgery or any history of GI surgery (including cholecystectomy, excluding appendectomy and uncomplicated hernia repair) that is anticipated to affect the absorption of the study drug.
- Any major surgery within 6 months (≤ 6 months) of screening.
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 |
|---|---|---|
| INCB123667INCB123667 will be administered orally as a tablet dose, followed approximately 10 minutes later by an oral dose solution of radiolabeled INCB123667. | Drug | Treatment: INCB123667 |
Primary outcome
Total Recovery (Urine + Feces) of the Administered Radioactivity
Time frame: Approximately 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 approximately 2 months
To characterize the metabolic profile and identify circulating and excreted metabolites of INCB123667 following administration of a single oral dose of INCB123667 followed by an oral dose solution of [14C]-INCB123667 using liquid chromatography with mass spectral detection.
13 secondary outcomes
PK for plasma INCB123667: Cmax
Time frame: Up to approximately 2 months
PK for plasma INCB123667: tmax
Time frame: Up to approximately 2 months
PK for plasma INCB123667: AUClast
Time frame: Up to approximately 2 months
PK for plasma INCB123667: AUCinf
Time frame: Up to approximately 2 months
PK for plasma INCB123667: t½
Time frame: Up to approximately 2 months
PK for plasma INCB123667: CL/F
Time frame: Up to approximately 2 months
PK for plasma INCB123667: Vz/F
Time frame: Up to approximately 2 months
PK for whole blood and plasma total radioactivity: Cmax
Time frame: Up to approximately 2 months
PK for whole blood and plasma total radioactivity: tmax
Time frame: Up to approximately 2 months
PK for whole blood and plasma total radioactivity: t½
Time frame: Up to approximately 2 months
PK for whole blood and plasma total radioactivity: AUClast
Time frame: Up to approximately 2 months
PK for whole blood and plasma total radioactivity: AUCinf
Time frame: Up to approximately 2 months
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 7 Jan 2026.
- Study Assessing the Mass Balance, Pharmacokinetics, and Metabolite Profiles of a Single Oral Dose of \[14C\]-INCB123667 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 INCB123667 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 5 inclusion and 15 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 7 Jan 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: Approximately 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 7 Jan 2026.