Effect of Renal Impairment on Enpatoran Pharmacokinetics

NCT06589713 | Completed Phase 1

• 2 other identifiers: MS200569_00512024-513393-22-00
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Renal Impairment

Keywords

Renal impairment; Clinical pharmacology; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetic (PK) Plasma Concentrations of Enpatoran

  Predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, and 48 hours postdose

Secondary Outcomes (2)

• 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

Study Arms (2)

Control Group 1 (Normal Renal Function)

EXPERIMENTAL

Drug: Enpatoran

Group 2 (Impaired Renal Function)

EXPERIMENTAL

Drug: Enpatoran

Interventions

Enpatoran DRUG

Participants will receive a single oral dose of enpataron tablets once daily.

Control Group 1 (Normal Renal Function); Group 2 (Impaired Renal Function)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: collaborator
• Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany: lead

Study Sites (1)

CRS Clinical Research Services Kiel GmbH

Kiel, Schleswig-Holstein, 24105, Germany

Location

Related Links

• Trial Awareness and Transparency website
• Medical Information Location Map - Med Info Contacts

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Medical Responsible

  Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2024
• First Posted: September 19, 2024
• Study Start: September 24, 2024
• Primary Completion: April 13, 2026
• Study Completion: April 13, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)