Status:
COMPLETED
Effect of Renal Impairment on Evobrutinib Pharmacokinetics (PK)
Lead Sponsor:
Merck KGaA, Darmstadt, Germany
Conditions:
Renal Impairment
Eligibility:
All Genders
18-79 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 21 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 22 2019
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT03436394
Start Date
March 21 2018
End Date
February 22 2019
Last Update
May 16 2019
Active Locations (1)
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1
Please Contact the Merck KGaA Communication Center
Darmstadt, Germany, 64293