Renal Impairment
Conditions
Keywords
Renal impairment, Clinical pharmacology, Pharmacokinetics
Brief summary
The purpose of this study is to assess the effect of renal impairment on the pharmacokinetics of enpatoran.
Interventions
DRUGEnpatoran
Participants will receive a single oral dose of enpataron tablets once daily.
Sponsors
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Merck KGaA, Darmstadt, Germany
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic (PK) Plasma Concentrations of Enpatoran | Predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, and 48 hours postdose |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants with Treatment-Emergent Adverse Events (TEAEs) | Up to Day 35 |
| Number of Participants with Abnormal Vital Signs, Laboratory Variables and 12-Lead Electrocardiogram (ECG) | Baseline and up to Day 35 |
Countries
Germany
Contacts
STUDY_DIRECTORMedical Responsible
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Outcome results
None listed