Other

A study assessing the Mass Balance, Pharmacokinetics, and Metabolite Profiles of a Single Oral Dose of [14C]INCB099280 in Healthy Male Participants

Incyte Study ID:
INCB99280-102
CT.gov ID:
NCT06309394
Eudra ID:
N/A
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
1.855.463.3463 or [email protected]
Study Complete
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Clinical Study Purpose

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.

Clinical Study Summary

MEDICAL CONDITION(S)
  • Other
    • PRODUCT
  • Drug: INCB099280
    • COLLABORATORS
    N/A
    DATE
    May 2024 - Jun 2024
    TYPE
    Interventional
    PHASE
    Phase 1
    SEX
    Male only
    AGE
    35 - 55 Years
    ACCEPTS HEALTHY VOLUNTEERS
    Yes

    Key Inclusion and Exclusion Criteria

    Inclusion Criteria

    • 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.

    Exclusion Criteria

    • 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).

    Clinical Study Locations

    Location
    Status
    Location
    QUOTIENT SCIENCES LTD
    NOTTINGHAM, United Kingdom, NG11 6JS
    Status
    Recruiting

    Protocol Summary

    Incyte Study ID:
    INCB99280-102
    Primary Purpose:
    Treatment
    Allocation:
    N/A
    Study Design:
    Single Group Assignment
    Masking:
    None (Open Label)
    Interventions:
    Drug
    Enrollment:
    5
    Primary Outcome
    Open

    Total recovery of radioactivity from urine and feces.

    Timeframe: Approximately 2 months

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

    Timeframe: Approximately 2 months

    Secondary Outcome
    Open

    Pharmacokinetic (PK) in Plasma

    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, post dose Day 6

    PK for whole blood and plasma total radioactivity

    Timeframe: Pre dose and post dose Day 1, post dose Days 2, 3, 4, 5, 6 and Days 7-12 as needed until study discharge

    Number of participants with Treatment Emergent Adverse Events (TEAEs)

    Timeframe: Approximately 2 months