Effect of Renal Impairment on Evobrutinib Pharmacokinetics (PK)

NCT ID: NCT03436394

Last Updated: 2019-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-21
• Study Completion Date: 2019-02-22

Brief Summary

The study will investigate the PK and safety of evobrutinib in subjects with different degree of renal impairment as compared to subjects with normal renal function.

Conditions

Renal Impairment

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Evobrutinib: Normal Renal Function

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 Type: EXPERIMENTAL

Evobrutinib

Intervention Type: DRUG

Subjects will be administered a single oral dose of evobrutinib under fasting conditions.

Evobrutinib: Severe Renal Impairment

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

Group Type: EXPERIMENTAL

Evobrutinib

Intervention Type: DRUG

Subjects will be administered a single oral dose of evobrutinib under fasting conditions.

Evobrutinib: Moderate Renal Impairment

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 Type: EXPERIMENTAL

Evobrutinib

Intervention Type: DRUG

Subjects will be administered a single oral dose of evobrutinib under fasting conditions.

Evobrutinib: Mild Renal Impairment

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 Type: EXPERIMENTAL

Evobrutinib

Intervention Type: DRUG

Subjects will be administered a single oral dose of evobrutinib under fasting conditions.

Interventions

Evobrutinib

Subjects will be administered a single oral dose of evobrutinib under fasting conditions.

Intervention Type: DRUG

Other Intervention Names

MSC2364447C; M2951

Eligibility Criteria

Inclusion Criteria

• 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

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, 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck KGaA, Darmstadt, Germany

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Responsible

Role: STUDY_DIRECTOR

Merck KGaA, Darmstadt, Germany

Locations

Please Contact the Merck KGaA Communication Center

Darmstadt, , Germany

Countries

Germany

Other Identifiers

2017-004102-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MS200527_0026

Identifier Type: -

Identifier Source: org_study_id