Other

A Study to Evaluate the Effect of Food on the Single-Dose Pharmacokinetics of INCB123667 When Administered Orally to Healthy Adult Participants

Incyte Study ID:
INCB123667-102
CT.gov ID:
NCT06909162>
Eudra ID:
N/A
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
1.855.463.3463 or [email protected]
Will Be Recruiting
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Clinical Study Purpose

This study will be conducted to evaluate the effect of food on the single-dose pharmacokinetics of INCB123667 when administered orally to healthy adult participants.

Clinical Study Summary

MEDICAL CONDITION(S)
  • Other
    • PRODUCT
  • Drug: INCB123667
    • COLLABORATORS
    N/A
    DATE
    May 2025 - May 2025
    TYPE
    Interventional
    PHASE
    Phase 1
    SEX
    Female & Male
    AGE
    19 - 55 Years
    ACCEPTS HEALTHY VOLUNTEERS
    Yes

    Clinical Study Locations

    No locations found.

    Key Inclusion and Exclusion Criteria

    Inclusion Criteria

    • Ability to comprehend and willingness to sign a written ICF for the study.
    • Age 19 (in compliance with Nebraska state law) to 55 years, inclusive, at the time of signing the ICF.

    Exclusion Criteria

    • History of uncontrolled or unstable cardiovascular, respiratory, renal, gastrointestinal, endocrine, hematopoietic, psychiatric, and/or neurological disease within 6 months of screening.
    • History of an autoimmune disease diagnosis (i.e., myasthenia gravis).

    Protocol Summary

    Incyte Study ID:
    INCB123667-102
    Primary Purpose:
    Treatment
    Allocation:
    Randomized
    Study Design:
    Crossover Assignment
    Masking:
    None (Open Label)
    Interventions:
    Drug
    Enrollment:
    15
    Primary Outcome
    Open

    Pharmacokinetics Parameter (PK): Cmax of INCB123667

    Timeframe: Up to Day 12

    Pharmacokinetics Parameter: Tmax of INCB123667

    Timeframe: Up to Day 12

    Pharmacokinetics Parameter: AUCt of INCB123667

    Timeframe: Up to Day 12

    Pharmacokinetics Parameter: AUC∞ of INCB123667

    Timeframe: Up to Day 12

    Secondary Outcome
    Open

    Number of participants with Treatment-emergent Adverse Events (TEAEs)

    Timeframe: Up to Day 25

    Pharmacokinetics Parameter: t½ of INCB123667

    Timeframe: Up to Day 12

    Pharmacokinetics Parameter: CL/F of INCB123667

    Timeframe: Up to Day 12

    Pharmacokinetics Parameter: Vz/F of INCB123667

    Timeframe: Up to Day 12