Healthy VolunteersPhase 1NCT05101369
A Study Assessing the Mass Balance, Pharmacokinetics, and Metabolite Profiles of a Single Oral Dose of [14C]-INCB086550
A Phase 1 study testing INCB086550 in people with Healthy Volunteers, run by Incyte Corporation at 1 site in United Kingdom.
Trial summary
To evaluate the absorption, metabolism, and excretion of 86550-106 in healthy males. 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 Volunteers
- What is being tested?
- INCB086550
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Jan 2022to 25 Mar 2022
- 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 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.
- Male healthy adult participants aged 35 to 55 years, inclusive, at the time of screening.
- Body mass index between 18.0 and 32.0 kg/m2, inclusive, at the time of screening.
- No clinically significant findings in screening evaluations (clinical, laboratory, vital signs, and ECG).
- Ability to swallow and retain oral medication.
- Willingness to avoid fathering children based on the criteria below. a. Male participants with reproductive potential must agree to take appropriate precautions to avoid fathering children from screening through 90 days (a spermatogenesis cycle) after the dose of study drug and must refrain from donating sperm during this period. Permitted methods in preventing pregnancy should be communicated to the participants and their understanding confirmed.
Who cannot join
- History of clinically significant respiratory, renal, gastrointestinal, endocrine, hematopoietic, psychiatric, and/or neurological disease.
- 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).
- History of rheumatologic/autoimmune disorders, except for minor eczema and rosacea.
- Resting pulse < 40 bpm or > 100 bpm, confirmed by repeat testing at screening.
- History or presence of an abnormal ECG at screening or predose on Day 1 that, in the investigator's opinion, is clinically significant. QTcF interval > 450 milliseconds, QRS interval > 120 milliseconds, and PR interval > 220 milliseconds.
- Presence of a malabsorption syndrome possibly affecting drug absorption (eg, Crohn's disease or chronic pancreatitis). Hemoglobin, WBC, platelet, or absolute neutrophil count that is out of the laboratory's range unless considered clinically insignificant by the investigator at screening or check-in.
Show all 33Show fewer
- Hepatic transaminases (ALT and AST), ALP, or total bilirubin > 1.25 × the laboratory-defined ULN at screening or check-in, confirmed by repeat testing (except participants with Gilbert's disease, for which total bilirubin must be ≤ 2.0 × ULN).
- History of malignancy within 5 years of screening, with the exception of cured basal cell or squamous cell carcinoma of the skin.
- Current or recent (within 6 months of 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 of screening (within 2 weeks for plasma donation).
- Blood transfusion within 4 weeks of check-in.
- Chronic or current active infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment (includes any history of tuberculosis).
- Positive test for HBV, HCV, or HIV. Participants whose results are compatible with prior immunization or immunity due to infection for HBV may be included at the discretion of the investigator.
- History of alcohol dependency within 3 years of screening.
- Consumption of alcohol 72 hours before check-in (Day -1) until CRU discharge.
- Positive breath test for alcohol or positive urine screen for drugs of abuse (confirmed by repeat) at screening or check-in that are not otherwise explained by permitted concomitant medications.
- Current treatment or treatment within 90 days or 5 half-lives (whichever is longer) prior to dosing in this study with another investigational medication or current enrollment in another investigational drug study.
- Participated in any clinical study involving a radiolabeled investigational product within 12 months prior to check-in.
- Current treatment or treatment within 30 days or 5 half-lives (whichever is longer) prior to dosing in this study with any medications known to be an inducer or inhibitor of CYP3A4, P-gp, or BCRP (refer to the Drug Interaction Database Program [University of Washington School of Pharmacy 2002] for prohibited drugs).
- Consumption of Seville oranges, grapefruit, pomelos, exotic citrus fruits, grapefruit hybrids, or any fruit juices (including but not limited to juices containing Seville orange, grapefruit, pomelo, exotic citrus fruits, or grapefruit hybrids) within 72 hours prior to dosing until CRU discharge.
- Consumption of poppy seeds within 7 days prior to screening and check-in. Consumption of caffeine- or xanthine-containing products (eg, coffee, tea, cola drinks, and chocolate) for 72 hours prior to dosing until CRU discharge.
- History of any significant drug allergy (such as anaphylaxis or hepatotoxicity) deemed clinically relevant by the investigator.
- Known hypersensitivity or severe reaction to INCB086550 or any excipients of INCB086550 (refer to the IB).
- Inability to undergo venipuncture or tolerate venous access.
- Inability or unlikeliness of the participant to comply with the dose schedule and study evaluations, in the opinion of the investigator.
- History of tobacco- or nicotine-containing product use within 1 month of screening.
- Consumption of tobacco- or nicotine-containing products 72 hours before check-in (Day -1) until CRU discharge is not permitted.
- Participation in strenuous exercise from 7 days before check-in until CRU discharge.
- Use of prescription drugs within 14 days of study drug administration or nonprescription medications/products (including vitamins, minerals, and phytotherapeutic, herbal, or plant-derived preparations) within 7 days prior to study drug administration and during the study. However, paracetamol up to 1000 mg Q24H and ibuprofen up to 600 mg Q24H are permitted.
- Use or intention to use any COVID-19 vaccine within 30 days prior to Day 1 and through CRU discharge or ET.
- Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
- eGFR < 90 mL/min/1.73 m2 based on the site's preferred formula at screening, check-in,or both.
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]-INCB086550
To evaluate the absorption, metabolism, and excretion of 86550-106 in healthy males.
Read the detailed description
The purpose of this study is to determine the absorption, metabolism, and excretion of a single oral dose of 400 mg (4x100 mg tablets) of INCB086550 followed by an oral dose solution of approximately 100 μCi (3.7 MBq) [14C]-INCB086550 and to characterize and determine the metabolites present in plasma, urine, and, where possible, feces in healthy male participants .
- Conditions
- Healthy Volunteers
- Being tested
- INCB086550
- Keywords
- healthy volunteers, male only
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INCB086550Drug
INCB086550 will be administered orally, followed approximately 10 minutes later by an oral dose solution of radio labeled INCB086550.
| Study group | Role | What they receive |
|---|---|---|
| INCB086550 | Experimental | Participants will be administered INCB086550 orally, followed approximately 10 minutes later by an oral dose solution of radio labeled INCB086550. Receives: Drug: INCB086550 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total recovery of radioactivity from urine and feces.
To determine the route of elimination and mass balance of [14C]-INCB086550 following administration of a single oral dose of 400 mg of INCB086550 followed by an oral dose solution of approximately 100 μCi (3.7 MBq) [14C]-INCB086550.
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 INCB086550 following administration of a single oral dose of 400 mg of INCB086550 followed by an oral dose solution of approximately 100 μCi (3.7 MBq) [14C]-INCB086550 using liquid chromatography with mass spectral detection.
Measured: Up to approximately 2 months
Secondary outcomes (17)
PK for plasma INCB086550: Cmax
Maximum Observed Plasma Concentration of INCB086550 to evaluate the PK of total radioactivity and parent compound following administration of a single oral dose of 400 mg of INCB086550 followed by an oral dose solution of approximately 100 μCi (3.7 MBq) [14C]-INCB086550.
Measured: Pre dose and Post dose on Day 1, Post dose Day 2, post dose Day 3, post dose Day 4, post dose Day 5
PK for plasma INCB086550: tmax
Time to reach maximum (peak) Plasma concentration of INCB086550
Measured: Pre dose and Post dose on Day 1, Post dose Day 2, post dose Day 3, post dose Day 4, post dose Day 5
PK for plasma INCB086550: AUC0-t
Area under the single-dose plasma concentration-time curve from Hour 0 to the last quantifiable measurable plasma concentration of INCB086550
Measured: Pre dose and Post dose on Day 1, Post dose Day 2, post dose Day 3, post dose Day 4, post dose Day 5
PK for plasma INCB086550: AUC0-∞
area under the single-dose plasma concentration-time curve from Hour 0 to infinity of INCB086550
Measured: Pre dose and Post dose on Day 1, Post dose Day 2, post dose Day 3, post dose Day 4, post dose Day 5
PK for plasma INCB086550: t½
AUC to the end of dosing period of INCB086550
Measured: Pre dose and Post dose on Day 1, Post dose Day 2, post dose Day 3, post dose Day 4, post dose Day 5
PK for plasma INCB086550: λz
Terminal elimination rate constant of INCB086550
Measured: Pre dose and Post dose on Day 1, Post dose Day 2, post dose Day 3, post dose Day 4, post dose Day 5
PK for plasma INCB086550: CL/F
Oral dose clearance of INCB086550
Measured: Pre dose and Post dose on Day 1, Post dose Day 2, post dose Day 3, post dose Day 4, post dose Day 5
PK for plasma INCB086550: Vz/F
Apparent oral dose volume of distribution of INCB086550
Measured: Pre dose and Post dose on Day 1, Post dose Day 2, post dose Day 3, post dose Day 4, post dose Day 5
PK for Urine INCB086550: Ae
Cumulative amount of unchanged drug excreted into the urine. Urine will be collected for the following intervals relative to study treatment administration: -12 to 0 hours (predose void [spot sample] only) and 0 to 6, 6 to 12, and 12 to 24 hours postdose and continuing in 24-hour intervals until discharge.
Measured: Pre dose and Post dose daily up to day 11, until study discharge
PK for urine INCB086550: CLR
Renal clearance of the drug from plasma.
Measured: Pre dose and Post dose daily up to day 11, until study discharge
PK for Urine INCB086550: fe
Fraction of the intravenously administered drug excreted into the urine
Measured: Pre dose and Post dose daily up to day 11, until study discharge
PK for whole blood and plasma total radioactivity: Cmax
Maximum Observed Plasma Concentration
Measured: Pre dose and poste dose Day 1, post dose Days 2, 3, 4, 5 and Days 6-11 as needed until study discharge
PK for whole blood and plasma total radioactivity: tmax
Time to reach maximum (peak)
Measured: Pre dose and post dose Day 1, post dose Days 2, 3, 4, 5 and Days 6-11 as needed until study discharge
PK for whole blood and plasma total radioactivity: t½
To evaluate the PK of total radioactivity and parent compound following administration of a single oral dose of 400 mg of INCB086550 followed by an oral dose solution of approximately 100 μCi (3.7 MBq) [14C]-INCB086550.
Measured: Pre dose and post dose Day 1, post dose Days 2, 3, 4, 5 and Days 6-11 as needed until study discharge
PK for whole blood and plasma total radioactivity: AUC0-t
Area under the single-dose plasma concentration-time curve from Hour 0 to the last quantifiable measurable plasma concentration of INCB086550
Measured: Pre dose and post dose Day 1, post dose Days 2, 3, 4, 5 and Days 6-11 as needed until study discharge
PK for whole blood and plasma total radioactivity: AUC0-∞
To evaluate the PK of total radioactivity and parent compound following administration of a single oral dose of 400 mg of INCB086550 followed by an oral dose solution of approximately 100 μCi (3.7 MBq) [14C]-INCB086550.
Measured: Pre dose and post dose Day 1, post dose Days 2, 3, 4, 5 and Days 6-11 as needed until study discharge
Incidence of AEs, ECGs, vital signs, and clinical laboratory evaluation.
To evaluate the safety of a single oral dose of 400 mg of INCB086550 followed by an oral dose solution of approximately 100 μCi (3.7 MBq) [14C]-INCB086550.
Measured: up to approximately 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2021
- Study start21 Jan 2022
- Primary completion25 Mar 2022
- Study completion25 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jay Getsy, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05101369
- Sponsor's protocol ID
- INCB 86550-106
- Other IDs
- 2020-005879-12
- Status last verified
- Aug 2025
- First submitted
- 6 Oct 2021
- Last updated
- 21 Aug 2025
- Results posted
- No
- 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 21 Aug 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]-INCB086550
- ClinicalTrials.gov ID
- NCT05101369
- Acronym / sponsor ID
- INCB 86550-106
- Conditions
- Healthy Volunteers
- Keywords
- healthy volunteers, male only
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 21 Jan 2022 (actual)
- Primary completion
- 25 Mar 2022 (actual)
- Study completion
- 25 Mar 2022 (actual)
- First posted
- 1 Nov 2021 (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.
To evaluate the absorption, metabolism, and excretion of 86550-106 in healthy males.
Detailed description
The purpose of this study is to determine the absorption, metabolism, and excretion of a single oral dose of 400 mg (4x100 mg tablets) of INCB086550 followed by an oral dose solution of approximately 100 μCi (3.7 MBq) [14C]-INCB086550 and to characterize and determine the metabolites present in plasma, urine, and, where possible, feces 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 |
|---|---|---|
| INCB086550 | Experimental | Drug: INCB086550Participants will be administered INCB086550 orally, followed approximately 10 minutes later by an oral dose solution of radio labeled INCB086550. |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Ability to comprehend and willingness to sign a written ICF for the study.
- Male healthy adult participants aged 35 to 55 years, inclusive, at the time of screening.
- Body mass index between 18.0 and 32.0 kg/m2, inclusive, at the time of screening.
- No clinically significant findings in screening evaluations (clinical, laboratory, vital signs, and ECG).
- Ability to swallow and retain oral medication.
Key exclusion criteria (33 listed)
- History of clinically significant respiratory, renal, gastrointestinal, endocrine, hematopoietic, psychiatric, and/or neurological disease.
- 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).
- History of rheumatologic/autoimmune disorders, except for minor eczema and rosacea.
- Resting pulse < 40 bpm or > 100 bpm, confirmed by repeat testing at screening.
- History or presence of an abnormal ECG at screening or predose on Day 1 that, in the investigator's opinion, is clinically significant. QTcF interval > 450 milliseconds, QRS interval > 120 milliseconds, and PR interval > 220 milliseconds.
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 |
|---|---|---|
| INCB086550INCB086550 will be administered orally, followed approximately 10 minutes later by an oral dose solution of radio labeled INCB086550. | Drug | INCB086550 |
Primary outcome
Total recovery of radioactivity from urine and feces.
Time frame: Approximately 2 weeks
To determine the route of elimination and mass balance of [14C]-INCB086550 following administration of a single oral dose of 400 mg of INCB086550 followed by an oral dose solution of approximately 100 μCi (3.7 MBq) [14C]-INCB086550.
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 INCB086550 following administration of a single oral dose of 400 mg of INCB086550 followed by an oral dose solution of approximately 100 μCi (3.7 MBq) [14C]-INCB086550 using liquid chromatography with mass spectral detection.
17 secondary outcomes
PK for plasma INCB086550: Cmax
Time frame: Pre dose and Post dose on Day 1, Post dose Day 2, post dose Day 3, post dose Day 4, post dose Day 5
PK for plasma INCB086550: tmax
Time frame: Pre dose and Post dose on Day 1, Post dose Day 2, post dose Day 3, post dose Day 4, post dose Day 5
PK for plasma INCB086550: AUC0-t
Time frame: Pre dose and Post dose on Day 1, Post dose Day 2, post dose Day 3, post dose Day 4, post dose Day 5
PK for plasma INCB086550: AUC0-∞
Time frame: Pre dose and Post dose on Day 1, Post dose Day 2, post dose Day 3, post dose Day 4, post dose Day 5
PK for plasma INCB086550: t½
Time frame: Pre dose and Post dose on Day 1, Post dose Day 2, post dose Day 3, post dose Day 4, post dose Day 5
PK for plasma INCB086550: λz
Time frame: Pre dose and Post dose on Day 1, Post dose Day 2, post dose Day 3, post dose Day 4, post dose Day 5
PK for plasma INCB086550: CL/F
Time frame: Pre dose and Post dose on Day 1, Post dose Day 2, post dose Day 3, post dose Day 4, post dose Day 5
PK for plasma INCB086550: Vz/F
Time frame: Pre dose and Post dose on Day 1, Post dose Day 2, post dose Day 3, post dose Day 4, post dose Day 5
PK for Urine INCB086550: Ae
Time frame: Pre dose and Post dose daily up to day 11, until study discharge
PK for urine INCB086550: CLR
Time frame: Pre dose and Post dose daily up to day 11, until study discharge
PK for Urine INCB086550: fe
Time frame: Pre dose and Post dose daily up to day 11, until study discharge
PK for whole blood and plasma total radioactivity: Cmax
Time frame: Pre dose and poste dose Day 1, post dose Days 2, 3, 4, 5 and Days 6-11 as needed until study discharge
PK for whole blood and plasma total radioactivity: tmax
Time frame: Pre dose and post dose Day 1, post dose Days 2, 3, 4, 5 and Days 6-11 as needed until study discharge
PK for whole blood and plasma total radioactivity: t½
Time frame: Pre dose and post dose Day 1, post dose Days 2, 3, 4, 5 and Days 6-11 as needed until study discharge
PK for whole blood and plasma total radioactivity: AUC0-t
Time frame: Pre dose and post dose Day 1, post dose Days 2, 3, 4, 5 and Days 6-11 as needed until study discharge
PK for whole blood and plasma total radioactivity: AUC0-∞
Time frame: Pre dose and post dose Day 1, post dose Days 2, 3, 4, 5 and Days 6-11 as needed until study discharge
Incidence of AEs, ECGs, vital signs, and clinical laboratory evaluation.
Time frame: up to approximately 3 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 21 Aug 2025.
- 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.
Jay Getsy 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 INCB086550 in people with Healthy Volunteers, 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 6 inclusion and 33 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 21 Aug 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?
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 of radioactivity from urine and feces. (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 21 Aug 2025.