Effect of Renal Impairment on Evobrutinib Pharmacokinetics (PK)

Merck KGaA (EMD Serono)

Status and phase: Completed; Phase 1

Conditions: Renal Impairment

Treatments: Drug: Evobrutinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT03436394

MS200527_0026

2017-004102-18 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: Accepts Healthy Volunteers

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
• 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, 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
• Other protocol defined exclusion criteria could apply

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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31 participants in 4 patient groups

Evobrutinib: Normal Renal Function

Experimental group

Description:

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.

Treatment:

Drug: Evobrutinib

Evobrutinib: Severe Renal Impairment

Experimental group

Description:

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

Treatment:

Drug: Evobrutinib

Evobrutinib: Moderate Renal Impairment

Experimental group

Description:

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.

Treatment:

Drug: Evobrutinib

Evobrutinib: Mild Renal Impairment

Experimental group

Description:

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.

Treatment:

Drug: Evobrutinib