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

Incyte Study ID:
INCB 86550-106
CT.gov ID:
NCT05101369
View Results Summary
Eudra ID:
N/A
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
+800 00027423 or [email protected]
Study Complete
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Clinical Study Purpose

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

Clinical Study Summary

MEDICAL CONDITION(S)
  • Other
    • PRODUCT
  • Drug: INCB086550
    • COLLABORATORS
    N/A
    DATE
    Jan 2022 - Mar 2022
    TYPE
    Interventional
    PHASE
    Phase 1
    SEX
    Male only
    AGE
    35 - 55 Years
    ACCEPTS HEALTHY VOLUNTEERS
    Yes

    Clinical Study Locations

    Name
    Contact Us
    Name
    COVANCE LEEDS CRU
    LEEDS, United Kingdom, LS2 9LH

    Key Inclusion and Exclusion Criteria

    Inclusion Criteria

    • 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.

    Exclusion Criteria

    • History of clinically significant respiratory, renal, gastrointestinal, endocrine,
    • hematopoietic, psychiatric, and/or neurological disease.

    Protocol Summary

    Incyte Study ID:
    INCB 86550-106
    Primary Purpose:
    Treatment
    Allocation:
    N/A
    Study Design:
    Single Group Assignment
    Masking:
    None (Open Label)
    Interventions:
    Drug
    Enrollment:
    7
    Primary Outcome
    Open

    Total recovery of radioactivity from urine and feces.

    Timeframe: Approximately 2 weeks

    Percentage of total radioactive dose in Plasma, Urinary and Fecal Excretion

    Timeframe: Up to approximately 2 months

    Secondary Outcome
    Open

    PK for plasma INCB086550: Cmax

    Timeframe: 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

    Timeframe: 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

    Timeframe: 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-∞

    Timeframe: 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

    Timeframe: 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

    Timeframe: 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

    Timeframe: 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

    Timeframe: 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

    Timeframe: Pre dose and Post dose daily up to day 11, until study discharge

    PK for urine INCB086550: CLR

    Timeframe: Pre dose and Post dose daily up to day 11, until study discharge

    PK for Urine INCB086550: fe

    Timeframe: Pre dose and Post dose daily up to day 11, until study discharge

    PK for whole blood and plasma total radioactivity: Cmax

    Timeframe: 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

    Timeframe: 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

    Timeframe: 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

    Timeframe: 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-∞

    Timeframe: 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.

    Timeframe: up to approximately 3 months