Effect of Renal Impairment on Enpatoran Pharmacokinetics
NCT ID: NCT06589713
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
40 participants
INTERVENTIONAL
2024-09-24
2026-04-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Control Group 1 (Normal Renal Function)
Enpatoran
Participants will receive a single oral dose of enpataron tablets once daily.
Group 2 (Impaired Renal Function)
Enpatoran
Participants will receive a single oral dose of enpataron tablets once daily.
Interventions
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Enpatoran
Participants will receive a single oral dose of enpataron tablets once daily.
Eligibility Criteria
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Inclusion Criteria
* Medical history and physical examination without any ongoing clinically relevant findings 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 judged by the Investigator; absolute lymphocyte count and absolute neutrophil count must be within normal limits
For Group 2 (Impaired Renal Function):
* Medical history and physical examination without any ongoing clinically relevant findings except for the underlying disease leading to renal impairment and consequence diseases thereof
* Chronic kidney disease
* For participants under medication, stable medication for at least 1 month
Exclusion Criteria
* History of drug hypersensitivity, ascertained or presumptive allergy/hypersensitivity to the active drug substance and/or formulation ingredients; history of serious allergic reactions leading to hospitalization or any other hypersensitivity reaction in general, which may affect the safety of the participant and/or outcome of the study per the Investigator's discretion
* History or presence of epilepsy, neurological disorders with seizure propensity or undiagnosed loss of consciousness, severe head trauma within 6 months or severe depression within 12 months prior to Screening), or neuropsychiatric conditions
* History of serotonin syndrome
* Prior history of cholecystectomy or splenectomy, and any clinically relevant surgery within 6 months prior to Screening, which might interfere with the objectives of the study or the study procedures
18 Years
80 Years
ALL
No
Sponsors
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Merck KGaA, Darmstadt, Germany
INDUSTRY
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Responsible
Role: STUDY_DIRECTOR
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Locations
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CRS Clinical Research Services Kiel GmbH
Kiel, Schleswig-Holstein, Germany
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Related Links
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Trial Awareness and Transparency website
Medical Information Location Map - Med Info Contacts
Other Identifiers
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2024-513393-22-00
Identifier Type: OTHER
Identifier Source: secondary_id
MS200569_0051
Identifier Type: -
Identifier Source: org_study_id