A Study to Assess Safety of Cedirogant and How Cedirogant Moves Through the Body in Adult Participants With Mild, Moderate and Severe Hepatic Impairment

Study Identifier
M23-367
CT.gov Identifier
NCT05376839
EudraCT Identifier
Not available
EUCTIS ID
Not available
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844-663-3742 or [email protected]

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Study Details

Medical Condition
  • Liver, Pancreas & Gallbladder - Other
    • Study Drug
  • Cedirogant
    • Phase
    Phase 1
    Sex
    Female & Male
    Age
    18 - 75 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Body Mass Index (BMI) is ≥ 18.0 to \< 40 kg/m2 * A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile (except liver function tests for subjects with hepatic impairment), and 12-lead ECG
    Exclusion Criteria:
    * Clinically relevant abnormal medical history, abnormal findings on physical examination, vital signs, ECG, or laboratory tests (except liver function tests for subjects with hepatic impairment) at screening that is assessed as likely to interfere with the objectives of the trial or the safety of the subject. * History or evidence of active TB or latent TB infection * Evidence of dysplasia or history of malignancy (including lymphoma and leukemia) other than successfully treated non-metastatic cutaneous squamous cell, basal cell carcinoma or localized carcinoma in situ of cervix

    Protocol Summary

    The objective of this study is to evaluate the pharmacokinetics and safety of cedirogant following oral administration of multiple doses in adult participants with hepatic impairment and normal hepatic function.

    Study Locations

    Location
    Status
    Location
    Clinical Pharmacology of Miami /ID# 246573
    Miami, Florida, United States, 33014
    Status
    Not applicable
    Location
    Orlando Clinical Research Ctr /ID# 246052
    Orlando, Florida, United States, 32809
    Status
    Not applicable
    Location
    TX Liver Inst, Americ Res Corp /ID# 246572
    San Antonio, Texas, United States, 78215
    Status
    Not applicable