Effect of Renal Impairment on Enpatoran Pharmacokinetics

Merck KGaA (EMD Serono)

Status and phase: Enrolling; Phase 1

Conditions: Renal Impairment

Treatments: Drug: Enpatoran

Study type: Interventional

Funder types: Industry

Identifiers

NCT06589713

2024-513393-22-00 (Other Identifier)

MS200569_0051

Details and patient eligibility

About

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

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

40 participants in 2 patient groups

Control Group 1 (Normal Renal Function)

Experimental group

Treatment:

Drug: Enpatoran

Group 2 (Impaired Renal Function)

Experimental group

Treatment:

Drug: Enpatoran