A Study Assessing the Mass Balance, Pharmacokinetics, and Metabolite Profiles of a Single Oral Dose of [14C]-INCB086550

NCT05101369 | Completed Phase 1

• 2 other identifiers: INCB 86550-1062020-005879-12
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the absorption, metabolism, and excretion of 86550-106 in healthy males.

Conditions

Healthy Volunteers

Keywords

healthy volunteers; male only

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Up to approximately 2 months

Secondary Outcomes (17)

• PK for plasma INCB086550: Cmax

  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

  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

  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-∞

  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

  Pre dose and Post dose on Day 1, Post dose Day 2, post dose Day 3, post dose Day 4, post dose Day 5

Study Arms (1)

INCB086550

EXPERIMENTAL

Participants will be administered INCB086550 orally, followed approximately 10 minutes later by an oral dose solution of radio labeled INCB086550.

Drug: INCB086550

Interventions

INCB086550 DRUG

INCB086550 will be administered orally, followed approximately 10 minutes later by an oral dose solution of radio labeled INCB086550.

INCB086550

Eligibility Criteria

• Age: 35 Years - 55 Years
• Gender Eligibility Details: Healthy male participants meeting all of the inclusion and none of the exclusion criteria.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (1)

Covance Leeds Cru

Leeds, LS2 9LH, United Kingdom

Location

Study Officials

• Jay Getsy

  Incyte Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2021
• First Posted: November 1, 2021
• Study Start: January 21, 2022
• Primary Completion: March 25, 2022
• Study Completion: March 25, 2022
• Last Updated: August 21, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)