Assessing how kidney function affects the pharmacokinetics of enpatoran
Phase 1, Open Label, Single Dose Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics of Enpatoran in Male and Female Participants
This study is testing how kidney function affects the way the medication enpatoran is processed in the body, specifically for people with chronic kidney disease.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany Industry-sponsored |
| Locations | 1 site (Kiel, Schleswig-Holstein) |
| Trial ID | NCT06589713 on ClinicalTrials.gov |
What this trial studies
This study evaluates the impact of renal impairment on the pharmacokinetics of enpatoran, a medication used in clinical settings. Participants will be divided into two groups: those with normal renal function and those with chronic kidney disease. The study aims to understand how kidney function alters the absorption, distribution, metabolism, and excretion of enpatoran. By analyzing these differences, researchers hope to optimize dosing and improve treatment outcomes for patients with renal impairment.
Who should consider this trial
Good fit: Ideal candidates include individuals with chronic kidney disease as well as those with normal renal function for comparison.
Not a fit: Patients with acute renal failure or those with significant comorbidities affecting pharmacokinetics may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective dosing strategies for patients with renal impairment, enhancing their treatment outcomes.
How similar studies have performed: While studies on pharmacokinetics in renal impairment are common, the specific focus on enpatoran's pharmacokinetics in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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 * Other protocol defined inclusion criteria could apply Exclusion Criteria: * 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 * Other protocol defined exclusion criteria could apply
Where this trial is running
Kiel, Schleswig-Holstein
- CRS Clinical Research Services Kiel GmbH — Kiel, Schleswig-Holstein, Germany (Recruiting)
Study contacts
- Study coordinator: Communication Center
- Email: service@emdgroup.com
- Phone: +49 6151 72 5200
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.