Clinical trial NCT06589713: Effect of Renal Impairment on Enpatoran Pharmacokinetics
Official title: Phase 1, Open Label, Single Dose Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics of Enpatoran in Male and Female Participants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Renal Impairment
Keywords: Renal impairment
Clinical pharmacology
Pharmacokinetics
Lead sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
Collaborators: name: Merck KGaA, Darmstadt, Germany
First posted: 2024-09-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Pharmacokinetic (PK) Plasma Concentrations of Enpatoran
timeFrame: Predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, and 48 hours postdose
Secondary outcomes:
measure: Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Up to Day 35
measure: Number of Participants with Abnormal Vital Signs, Laboratory Variables and 12-Lead Electrocardiogram (ECG)
timeFrame: Baseline and up to Day 35
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: CRS Clinical Research Services Kiel GmbH
state: Schleswig-Holstein
Study officials:
affiliation: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
name: Medical Responsible
role: STUDY_DIRECTOR
References: