Healthy ParticipantsPhase 1NCT06309394
A Study Assessing the Mass Balance, Pharmacokinetics, and Metabolite Profiles of a Single Oral Dose of [14C]INCB099280 in Healthy Male Participants
A Phase 1 study testing INCB099280 in people with Healthy Participants, run by Incyte Corporation at 1 site in United Kingdom.
Trial summary
This study is being conducted to assess the Mass Balance, Pharmacokinetics, and Metabolite Profiles of a Single Oral Dose of [14C]INCB099280 in Healthy Male Participants. Read more about this study
- Who is it for?
- Ages 35 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- INCB099280
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 May 2024to 4 Jun 2024
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 35 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, as determined by the investigator based upon physical examinations, ECGs, vital signs, and safety laboratory assessments, aged 35 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, and ECG) at screening and Day -1.
- Ability to swallow and retain oral medication.
Who cannot join
- History of clinically significant respiratory, renal, gastrointestinal, endocrine, hematopoietic, psychiatric, and/or neurological disease as judged by the investigator.
- History of cardiovascular, cerebrovascular, peripheral vascular, or thrombotic disease or uncontrolled hypertension (systolic blood pressure > 140 mm Hg 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 (within 6 months before screening), clinically significant, gastrointestinal disease or surgery (including cholecystectomy, excluding appendectomy) that could affect the absorption of study drug.
- Any major surgery within 6 months of screening.
- Donation of blood to a blood bank or in a clinical study (except a screening visit) within 3 months before screening (within 2 weeks for plasma donation).
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- Positive test for HBV, HCV, or HIV at screening. Participants whose HBV results are compatible with prior immunization or immunity due to infection may be included at the discretion of the investigator.
- Regular alcohol consumption > 21 units per week (1 unit = 8 oz of beer or a 25-mL shot of a 40% spirit; 1.5 to 2 units = a 125-mL glass of wine, depending on type).
- Positive breath test for alcohol or positive urine screen for drugs of abuse (confirmed by repeat) at screening or admission (Day -1).
- Treatment with another investigational medication within 90 days or 5 half-lives (whichever is longer) before Day 1 or current enrollment in another investigational drug study.
- Participation in any clinical study involving a 14C-radiolabeled investigational product within 12 months prior to admission (Day -1).
- Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 2017, shall participate in the study.
- History of tobacco- or nicotine-containing product use within 1 month before screening. Consumption of tobacco- or nicotine-containing products 72 hours before admission (Day -1) until CRU discharge is not permitted. Breath test for carbon monoxide > 10 ppm (confirmed by repeat) at screening or admission (Day -1).
- Use of prescription drugs within 14 days before Day 1 or nonprescription medications/products (including vitamins, minerals, and phytotherapeutic, herbal, or plant-derived preparations) within 7 days before Day 1 until CRU discharge. However, paracetamol up to 4000 mg Q24H and ibuprofen up to 600 mg Q24H are permitted.
- 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]INCB099280 in Healthy Male Participants
This study is being conducted to assess the Mass Balance, Pharmacokinetics, and Metabolite Profiles of a Single Oral Dose of [14C]INCB099280 in Healthy Male Participants.
- Conditions
- Healthy Participants
- Being tested
- INCB099280
- Keywords
- INCB099280
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INCB099280Drug
INCB099280 will be administered orally, followed approximately 10 minutes later by an oral dose solution of radiolabeled INCB099280.
| Study group | Role | What they receive |
|---|---|---|
| INCB099280 | Experimental | Participants will be administered INCB099280 tablet orally, followed approximately 10 minutes later by an oral dose solution of radiolabeled INCB099280. Receives: Drug: INCB099280 |
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: 264 hours in urine; 408 hours in feces
Secondary outcomes (24)
Abundance of INCB099280 Detected in Plasma
Plasma samples for metabolism investigations were obtained at 0, 1, 2, 4, 8, 12, 16, and 24 hours post-dose and were pooled across participants at each timepoint. TRPA=total radioactive peak area. The reported values are single measurements of pooled plasma or fecal samples; therefore, no statistical analysis is possible, and data have been reported with a measure type of "number."
Measured: 0 hours (predose) and up to 24 hours post-dose
Abundance of INCB099280 Metabolites Detected in Feces
Homogenized fecal samples from individual participants were pooled for each collection interval by taking a fixed percentage of the total amount excreted from each collection interval/participant. The reported values are single measurements of pooled plasma or fecal samples; therefore, no statistical analysis is possible, and data have been reported with a measure type of "number."
Measured: 0 hours (predose) and up to 96 hours post-dose
Cmax of INCB099280
Cmax was defined as the maximum observed plasma or serum concentration of INCB099280.
Measured: 0 hours (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 hours post-dose (Day 1); 24 and 36 hours post-dose (Day 2); 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6)
Tmax of INCB099280
tmax was defined as the time to the maximum concentration of INCB099280.
Measured: 0 hours (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 hours post-dose (Day 1); 24 and 36 hours post-dose (Day 2); 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6)
AUC0-t of INCB099280
AUC0-t was defined as the area under the steady-state plasma or serum concentration-time curve up to the last measurable concentration of INCB099280.
Measured: 0 hours (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 hours post-dose (Day 1); 24 and 36 hours post-dose (Day 2); 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6)
AUC0-∞ of INCB099280
AUC0-∞ was defined as the area under the single-dose plasma or serum concentration-time curve extrapolated to time of infinity.
Measured: 0 hours (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 hours post-dose (Day 1); 24 and 36 hours post-dose (Day 2); 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6)
t½ of INCB099280
t½ was defined as the apparent terminal-phase disposition half-life of INCB099280.
Measured: 0 hours (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 hours post-dose (Day 1); 24 and 36 hours post-dose (Day 2); 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6)
CL/F of INCB099280
CL/F was defined as the apparent oral dose clearance of INCB099280.
Measured: 0 hours (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 hours post-dose (Day 1); 24 and 36 hours post-dose (Day 2); 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6)
Vz/F of INCB099280
Vz/F was defined as the maximum observed plasma or serum concentration of INCB099280.
Measured: 0 hours (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 hours post-dose (Day 1); 24 and 36 hours post-dose (Day 2); 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6)
Cmax of Total Radioactivity in Blood
Cmax was defined as the maximum observed concentration of total radioactivity in blood. Additional samples were collected every 24 hours until discharge (up to 264 hours).
Measured: 0 hours (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 hours post-dose (Day 1); 24 and 36 hours post-dose (Day 2); 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6)
Tmax of Total Radioactivity in Blood
tmax was defined as the time to the maximum concentration of total radioactivity in blood. Additional samples were collected every 24 hours until discharge (up to 264 hours).
Measured: 0 hours (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 hours post-dose (Day 1); 24 and 36 hours post-dose (Day 2); 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6)
AUC0-t of Total Radioactivity in Blood
AUC0-t was defined as the area under the steady-state plasma or serum concentration-time curve up to the last measurable concentration of total radioactivity in blood. Additional samples were collected every 24 hours until discharge (up to 264 hours).
Measured: 0 hours (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 hours post-dose (Day 1); 24 and 36 hours post-dose (Day 2); 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6)
AUC0-∞ of Total Radioactivity in Blood
AUC0-∞ was defined as the area under the single-dose plasma or serum concentration-time curve extrapolated to time of infinity. Additional samples were collected every 24 hours until discharge (up to 264 hours).
Measured: 0 hours (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 hours post-dose (Day 1); 24 and 36 hours post-dose (Day 2); 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6)
t½ of Total Radioactivity in Blood
t½ was defined as the apparent terminal-phase disposition half-life of total radioactivity in blood. Additional samples were collected every 24 hours until discharge (up to 264 hours).
Measured: 0 hours (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 hours post-dose (Day 1); 24 and 36 hours post-dose (Day 2); 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6)
CL/F of Total Radioactivity in Blood
CL/F was defined as the apparent oral dose clearance of total radioactivity in blood. Additional samples were collected every 24 hours until discharge (up to 264 hours).
Measured: 0 hours (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 hours post-dose (Day 1); 24 and 36 hours post-dose (Day 2); 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6)
Vz/F of Total Radioactivity in Blood
Vz/F was defined as the maximum observed plasma or serum concentration of total radioactivity in blood. Additional samples were collected every 24 hours until discharge (up to 264 hours).
Measured: 0 hours (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 hours post-dose (Day 1); 24 and 36 hours post-dose (Day 2); 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6)
Cmax of Total Radioactivity in Plasma
Cmax was defined as the maximum observed concentration of total radioactivity in plasma. Additional samples were collected every 24 hours until discharge (up to 264 hours).
Measured: 0 hours (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 hours post-dose (Day 1); 24 and 36 hours post-dose (Day 2); 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6)
Tmax of Total Radioactivity in Plasma
tmax was defined as the time to the maximum concentration of total radioactivity in plasma. Additional samples were collected every 24 hours until discharge (up to 264 hours).
Measured: 0 hours (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 hours post-dose (Day 1); 24 and 36 hours post-dose (Day 2); 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6)
AUC0-t of Total Radioactivity in Plasma
AUC0-t was defined as the area under the steady-state plasma or serum concentration-time curve up to the last measurable concentration of total radioactivity in plasma. Additional samples were collected every 24 hours until discharge (up to 264 hours).
Measured: 0 hours (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 hours post-dose (Day 1); 24 and 36 hours post-dose (Day 2); 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6)
AUC0-∞ of Total Radioactivity in Plasma
AUC0-∞ was defined as the area under the single-dose plasma or serum concentration-time curve extrapolated to time of infinity. Additional samples were collected every 24 hours until discharge (up to 264 hours).
Measured: 0 hours (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 hours post-dose (Day 1); 24 and 36 hours post-dose (Day 2); 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6)
t½ of Total Radioactivity in Plasma
t½ was defined as the apparent terminal-phase disposition half-life of total radioactivity in plasma. Additional samples were collected every 24 hours until discharge (up to 264 hours).
Measured: 0 hours (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 hours post-dose (Day 1); 24 and 36 hours post-dose (Day 2); 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6)
CL/F of Total Radioactivity in Plasma
CL/F was defined as the apparent oral dose clearance of total radioactivity in plasma. Additional samples were collected every 24 hours until discharge (up to 264 hours).
Measured: 0 hours (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 hours post-dose (Day 1); 24 and 36 hours post-dose (Day 2); 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6)
Vz/F of Total Radioactivity in Plasma
Vz/F was defined as the maximum observed plasma or serum concentration of total radioactivity in plasma. Additional samples were collected every 24 hours until discharge (up to 264 hours).
Measured: 0 hours (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 hours post-dose (Day 1); 24 and 36 hours post-dose (Day 2); 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6)
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug-related. An AE could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug.
Measured: up to Day 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start15 May 2024
- Primary completion4 Jun 2024
- Study completion4 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Incyte Medical, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06309394
- Sponsor's protocol ID
- INCB99280-102
- Status last verified
- Aug 2025
- First submitted
- 23 Feb 2024
- Last updated
- 11 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. 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]INCB099280 in Healthy Male Participants
- ClinicalTrials.gov ID
- NCT06309394
- Acronym / sponsor ID
- INCB99280-102
- Conditions
- Healthy Participants
- Keywords
- INCB099280
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 15 May 2024 (actual)
- Primary completion
- 4 Jun 2024 (actual)
- Study completion
- 4 Jun 2024 (actual)
- First posted
- 13 Mar 2024 (actual)
- Results
- Posted 11 Sep 2025
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 being conducted to assess the Mass Balance, Pharmacokinetics, and Metabolite Profiles of a Single Oral Dose of [14C]INCB099280 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 |
|---|---|---|
| INCB099280 | Experimental | Drug: INCB099280Participants will be administered INCB099280 tablet orally, followed approximately 10 minutes later by an oral dose solution of radiolabeled INCB099280. |
Who may qualify
- Ages
- 35 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, as determined by the investigator based upon physical examinations, ECGs, vital signs, and safety laboratory assessments, aged 35 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, and ECG) at screening and Day -1.
- Ability to swallow and retain oral medication.
Key exclusion criteria (15 listed)
- History of clinically significant respiratory, renal, gastrointestinal, endocrine, hematopoietic, psychiatric, and/or neurological disease as judged by the investigator.
- History of cardiovascular, cerebrovascular, peripheral vascular, or thrombotic disease or uncontrolled hypertension (systolic blood pressure > 140 mm Hg 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 (within 6 months before screening), clinically significant, gastrointestinal disease or surgery (including cholecystectomy, excluding appendectomy) that could affect the absorption of study drug.
- Any major surgery within 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 |
|---|---|---|
| INCB099280INCB099280 will be administered orally, followed approximately 10 minutes later by an oral dose solution of radiolabeled INCB099280. | Drug | INCB099280 |
Primary outcome
Total Recovery (Urine + Feces) of the Administered Radioactivity
Time frame: 264 hours in urine; 408 hours in feces
Radioactivity in urine and feces was reported as the percentage of the administered radioactivity excreted.
24 secondary outcomes
Abundance of INCB099280 Detected in Plasma
Time frame: 0 hours (predose) and up to 24 hours post-dose
Abundance of INCB099280 Metabolites Detected in Feces
Time frame: 0 hours (predose) and up to 96 hours post-dose
Cmax of INCB099280
Time frame: 0 hours (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 hours post-dose (Day 1); 24 and 36 hours post-dose (Day 2); 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6)
Tmax of INCB099280
Time frame: 0 hours (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 hours post-dose (Day 1); 24 and 36 hours post-dose (Day 2); 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6)
AUC0-t of INCB099280
Time frame: 0 hours (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 hours post-dose (Day 1); 24 and 36 hours post-dose (Day 2); 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6)
AUC0-∞ of INCB099280
Time frame: 0 hours (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 hours post-dose (Day 1); 24 and 36 hours post-dose (Day 2); 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6)
t½ of INCB099280
Time frame: 0 hours (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 hours post-dose (Day 1); 24 and 36 hours post-dose (Day 2); 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6)
CL/F of INCB099280
Time frame: 0 hours (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 hours post-dose (Day 1); 24 and 36 hours post-dose (Day 2); 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6)
Vz/F of INCB099280
Time frame: 0 hours (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 hours post-dose (Day 1); 24 and 36 hours post-dose (Day 2); 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6)
Cmax of Total Radioactivity in Blood
Time frame: 0 hours (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 hours post-dose (Day 1); 24 and 36 hours post-dose (Day 2); 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6)
Tmax of Total Radioactivity in Blood
Time frame: 0 hours (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 hours post-dose (Day 1); 24 and 36 hours post-dose (Day 2); 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6)
AUC0-t of Total Radioactivity in Blood
Time frame: 0 hours (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 hours post-dose (Day 1); 24 and 36 hours post-dose (Day 2); 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6)
AUC0-∞ of Total Radioactivity in Blood
Time frame: 0 hours (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 hours post-dose (Day 1); 24 and 36 hours post-dose (Day 2); 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6)
t½ of Total Radioactivity in Blood
Time frame: 0 hours (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 hours post-dose (Day 1); 24 and 36 hours post-dose (Day 2); 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6)
CL/F of Total Radioactivity in Blood
Time frame: 0 hours (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 hours post-dose (Day 1); 24 and 36 hours post-dose (Day 2); 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6)
Vz/F of Total Radioactivity in Blood
Time frame: 0 hours (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 hours post-dose (Day 1); 24 and 36 hours post-dose (Day 2); 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6)
Cmax of Total Radioactivity in Plasma
Time frame: 0 hours (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 hours post-dose (Day 1); 24 and 36 hours post-dose (Day 2); 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6)
Tmax of Total Radioactivity in Plasma
Time frame: 0 hours (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 hours post-dose (Day 1); 24 and 36 hours post-dose (Day 2); 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6)
AUC0-t of Total Radioactivity in Plasma
Time frame: 0 hours (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 hours post-dose (Day 1); 24 and 36 hours post-dose (Day 2); 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6)
AUC0-∞ of Total Radioactivity in Plasma
Time frame: 0 hours (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 hours post-dose (Day 1); 24 and 36 hours post-dose (Day 2); 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6)
t½ of Total Radioactivity in Plasma
Time frame: 0 hours (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 hours post-dose (Day 1); 24 and 36 hours post-dose (Day 2); 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6)
CL/F of Total Radioactivity in Plasma
Time frame: 0 hours (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 hours post-dose (Day 1); 24 and 36 hours post-dose (Day 2); 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6)
Vz/F of Total Radioactivity in Plasma
Time frame: 0 hours (predose) and 0.5, 1, 2, 4, 6, 8, 12, and 16 hours post-dose (Day 1); 24 and 36 hours post-dose (Day 2); 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6)
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
Time frame: up to Day 22
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 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 INCB099280 in people with Healthy Participants, run by Incyte Corporation at 1 site in United Kingdom.
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 11 Sep 2025. 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 Kingdom. 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?
Yes. Results are posted in the registry (first posted 11 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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: 264 hours in urine; 408 hours in feces). 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 11 Sep 2025.