RecruitingPhase 1NCT06589713
Effect of Renal Impairment on Enpatoran Pharmacokinetics
Phase 1, Open Label, Single Dose Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics of Enpatoran in Male and Female Participants
Sponsor
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Enrollment
40 participants
Start Date
Sep 24, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
The purpose of this study is to assess the effect of renal impairment on the pharmacokinetics of enpatoran.
Eligibility
Min Age: 18 YearsMax Age: 80 Years
Inclusion Criteria7
- For Control Group 1 (Normal Renal Function):
- 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 Criteria5
- History or presence of respiratory, gastrointestinal (including bariatric or other gastric surgeries, or other conditions that may affect drug absorption), hepatic (including hepatorenal syndrome), hematological, lymphatic, cardiovascular (such as ventricular dysfunction and congestive heart failure, cardiac arrythmia), psychiatric, neurological, genitourinary, immunological, dermatological, connective tissue diseases, or disorders that may affect the safety of the participant.
- 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
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Interventions
DRUGEnpatoran
Participants will receive a single oral dose of enpataron tablets once daily.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06589713
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