Effect of Renal Impairment on Enpatoran Pharmacokinetics

Last updated: February 18, 2025
Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Overall Status: Active - Recruiting

Phase

1

Condition

Renal Failure

Kidney Failure (Pediatric)

Nephropathy

Treatment

Enpatoran

Clinical Study ID

NCT06589713
MS200569_0051
2024-513393-22-00
  • Ages 18-80
  • All Genders

Study Summary

The purpose of this study is to assess the effect of renal impairment on the pharmacokinetics of enpatoran.

Eligibility Criteria

Inclusion

Inclusion Criteria:

For Control Group 1 (Normal Renal Function):

  • Medical history and physical examination without any ongoing clinically relevantfindings as judged by the Investigator

  • No clinically relevant findings (only minor deviations) in biochemistry, hematology,coagulation, and urinalysis examinations for the age of the participant, as judgedby the Investigator; absolute lymphocyte count and absolute neutrophil count must bewithin normal limits

For Group 2 (Impaired Renal Function):

  • Medical history and physical examination without any ongoing clinically relevantfindings except for the underlying disease leading to renal impairment andconsequence diseases thereof

  • Chronic kidney disease

  • For participants under medication, stable medication for at least 1 month

  • Other protocol defined inclusion criteria could apply

Exclusion

Exclusion Criteria:

  • History or presence of respiratory, gastrointestinal (including bariatric or othergastric surgeries, or other conditions that may affect drug absorption), hepatic (including hepatorenal syndrome), hematological, lymphatic, cardiovascular (such asventricular dysfunction and congestive heart failure, cardiac arrythmia),psychiatric, neurological, genitourinary, immunological, dermatological, connectivetissue diseases, or disorders that may affect the safety of the participant.

  • History of drug hypersensitivity, ascertained or presumptiveallergy/hypersensitivity to the active drug substance and/or formulationingredients; history of serious allergic reactions leading to hospitalization or anyother hypersensitivity reaction in general, which may affect the safety of theparticipant and/or outcome of the study per the Investigator's discretion

  • History or presence of epilepsy, neurological disorders with seizure propensity orundiagnosed loss of consciousness, severe head trauma within 6 months or severedepression within 12 months prior to Screening), or neuropsychiatric conditions

  • History of serotonin syndrome

  • Prior history of cholecystectomy or splenectomy, and any clinically relevant surgerywithin 6 months prior to Screening, which might interfere with the objectives of thestudy or the study procedures

  • Other protocol defined exclusion criteria could apply

Study Design

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: Enpatoran
Phase: 1
Study Start date:
September 24, 2024
Estimated Completion Date:
December 04, 2025

Connect with a study center

  • CRS Clinical Research Services Kiel GmbH

    Kiel, Schleswig-Holstein 24105
    Germany

    Active - Recruiting

  • Please Contact the Communication Center

    Darmstadt, 64293
    Germany

    Site Not Available

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