Completed

Evobrutinib Pharmacokinetics in Renal Impairment vs Normal Function

Study Aim

This study aims to evaluate how Evobrutinib is processed in the body of individuals with normal kidney function compared to those with kidney impairment, by measuring the maximum observed plasma concentration and the area under the plasma concentration-time curve.

What is being tested

Evobrutinib

Drug

Who is being recruted

Urogenital Diseases+4

+ Female Urogenital Diseases and Pregnancy Complications

+ Kidney Diseases

From 18 to 79 Years

+8 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Other Study

Phase 1

Interventional

Study Start: March 2018

See protocol details

Summary

Principal SponsorMerck KGaA, Darmstadt, Germany

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: March 21, 2018

Actual date on which the first participant was enrolled.

This study focuses on a drug called Evobrutinib (M2951). The main goal is to understand how well and safely this drug works in people with various levels of kidney function, compared to those with normal kidney function. This research is important because it helps determine how kidney function might affect the drug's behavior in the body, which can guide its use in people with kidney issues. The study involves both male and female participants. In this study, participants receive a single dose of Evobrutinib. The study then measures specific outcomes to evaluate the drug's performance. These include the maximum concentration of the drug in the blood, and the area under the plasma concentration-time curve, which helps understand how the drug is absorbed and eliminated over time. These measurements provide valuable insights into the drug's safety and effectiveness in individuals with different kidney functions.

Official TitlePhase I, Open-label, Single Dose Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics (PK) of Evobrutinib (M2951) Compared to Normal Renal Function in Male and Female Subjects

NCT03436394

Principal SponsorMerck KGaA, Darmstadt, Germany

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

31 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other Study

Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 79 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsKidney DiseasesUrologic DiseasesRenal InsufficiencyFemale Urogenital DiseasesMale Urogenital Diseases

Criteria

3 inclusion criteria required to participate

Male and Female subjects with total body weight between 50.0 and 100.0 kilograms(kg) (inclusive) and body mass index (BMI) between 19.0 and 36.0 kg per meter square (inclusive) at the time of the screening examination

For subjects with impaired renal function: Subjects must have an eGFR according to the Modification of diet in renal disease (MDRD) equation of less than 90 mL per minute at screening and the possibility of stratification to one of the groups and a stable renal function as defined by either: if the time interval between screening and dosing is greater than 10 days, two eGFR with the second estimate within 20% of prior value or historical records of stable function over the past 3 months if within 20 percentage of screening value and within 10 days of dosing

Other protocol defined inclusion criteria could apply

5 exclusion criteria prevent from participating

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, neurological (including seizures), cardiovascular (including ventricular dysfunction and congestive heart failure), psychiatric, musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases or disorders that may affect the safety of the subject.

Clinical history of any autoimmune disorder

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

History of any malignancy except superficial basal cell carcinoma treated for curative intent may be allowed

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

4 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Subjects with eGFR \>= to 60 mL/min/1.73 m\^2 and \< 90 mL/min/1.73 m\^2 will receive a single oral dose of evobrutinib under fasting conditions.

Group II

Experimental

Subjects with eGFR \>= to 30 mL/min/1.73 m\^2 and \< 60 mL/min/1.73 m\^2 will receive a single oral dose of evobrutinib under fasting conditions.

Group III

Experimental

Subjects with estimated glomerular filtration rate (eGFR) greater than or equal to (\>=) 90 milliliter per minute per 1.73 meter square (mL/min/1.73 m\^2) will receive a single oral dose of evobrutinib under fasting conditions.

Group IV

Experimental

Subjects with eGFR less than (\<) 30 mL/min/1.73 m\^2 will receive a single oral dose of evobrutinib under fasting conditions.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Please Contact the Merck KGaA Communication Center

Darmstadt, GermanyOpen Please Contact the Merck KGaA Communication Center in Google Maps

CompletedOne Study Center