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A Study to Evaluate the Pharmacokinetics and Safety of INCB054707 in Participants With Normal Hepatic Function and Participants With Hepatic Impairment

Incyte Study ID:
INCB 54707-105
CT.gov ID:
NCT05624710
View Results Summary
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 is a multicenter, open-label, parallel-group study to evaluate INCB054707 in participants with varying levels of renal function or impairment.

Clinical Study Summary

MEDICAL CONDITION(S)
  • Other
    • PRODUCT
  • Drug: INCB054707
    • COLLABORATORS
    N/A
    DATE
    Dec 2022 - Jun 2023
    TYPE
    Interventional
    PHASE
    Phase 1
    SEX
    Female & Male
    AGE
    18 - 80 Years
    ACCEPTS HEALTHY VOLUNTEERS
    Yes

    Clinical Study Locations

    Name
    Contact Us
    Name
    APEX GMBH
    MUNICH, Germany, D-81241
    Name
    ORLANDO CLINICAL RESEARCH CENTER
    ORLANDO, FL, US, 32809
    Name
    ORANGE COUNTY RESEARCH CENTER
    TUSTIN, CA, US, 92780
    Name
    TEXAS LIVER INSTITUTE TLI THE LIVER INSTITUTE OF SOUTH TEXAS LIST DOWNTOWN OFFICE
    SAN ANTONIO, TX, US, 78215

    Key Inclusion and Exclusion Criteria

    Inclusion Criteria

    • Participants with hepatic impairment will be classified at screening based on Child-Pugh
    • score. Classification will be repeated at check-in and should not be significantly different.

    Exclusion Criteria

    • the opinion of the principal investigator, history of uncontrolled or unstable cardiovascular, respiratory, renal, GI, endocrine, hematopoietic, psychiatric, and/or neurological disease within 6 months of screening or evidence of rapidly deteriorating
    • hepatic function.

    Protocol Summary

    Incyte Study ID:
    INCB 54707-105
    Primary Purpose:
    Treatment
    Allocation:
    Non-randomized
    Study Design:
    Parallel Assignment
    Masking:
    None (Open Label)
    Interventions:
    Drug
    Enrollment:
    25
    Primary Outcome
    Open

    Pharmacokinetics Parameter: Cmax of INCBC054707

    Timeframe: Days 1 - 5

    Pharmacokinetics Parameter: AUC(0-t) of INCB054707

    Timeframe: Days 1 - 5

    Pharmacokinetics Parameter: AUC(0-∞) of INCB054707

    Timeframe: Days 1 - 5

    Secondary Outcome
    Open

    Number of Treatment Emergent Adverse Events (TEAE'S)

    Timeframe: up to 15 days

    Pharmacokinetics Parameter: tmax of INCB054707

    Timeframe: Days 1 - 5

    Pharmacokinetics Parameter: t1/2 0f INCB054707

    Timeframe: Days 1 - 5

    Pharmacokinetics Parameter: CL/F of INCB054707

    Timeframe: Days 1 - 5

    Pharmacokinetics Parameter:: Vz/F of INCB054707

    Timeframe: Days 1 - 5