Human Absorption, Distribution, Metabolism and Excretion (ADME) of [14C]-Evobrutinib

Merck KGaA (EMD Serono)

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Evobrutinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT03725072

2018-003371-35 (EudraCT Number)

MS200527_0075

Details and patient eligibility

About

The purpose of the study is to determine the absorption, metabolism, and excretion of [14C]-evobrutinib in healthy participants

Enrollment

6 patients

Sex

Male

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Participants are overtly healthy as determined by medical evaluation, including medical history, physical examination, laboratory tests, and cardiac monitoring
Have a body weight within 50.0 to 120.0 kilogram (kg) (inclusive) and body mass index within the range 19.0 - 30.0 kilogram per meter square (kg/m^2) (inclusive)
Male participants agree to be consistent with local regulations on contraception methods
Can give signed informed consent
Other protocol defined inclusion criteria could apply

Exclusion criteria

History or presence of clinically relevant respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases or disorders
Prior history of cholecystectomy or splenectomy, and any clinically relevant surgery
Any surgical or medical condition which might significantly alter the ADME of drugs
History of any malignancy, chronic or recurrent acute infection
History of shingles
History of drug hypersensitivity ascertained or presumptive allergy/hypersensitivity to the active drug substance and/or formulation ingredients
History of alcoholism or drug abuse
History of residential exposure to tuberculosis, or a positive QuantiFERON test at screening
Administration of live vaccines or live-attenuated virus vaccines
Any condition, including findings in the laboratory tests, medical history, or other screening assessments, that in the opinion of the Investigator constitutes an inappropriate risk or a contraindication for participation in the study or that could interfere with the study's objectives, conduct, or evaluation
Prior/concomitant therapy
Relevant radiation exposure
Clinically relevant findings (excluding minor deviations) in biochemistry, hematology, coagulation and urinalysis
Vital signs (pulse rate and blood pressure) outside the normal range
Estimated Glomerular Filtration rate according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)
Semi supine systolic blood pressure (SBP) greater than (>) 140 millimeters of Mercury (mmHg) or less than (<) 90 mmHg, diastolic blood pressure (DBP) > 90 mmHg or < 45 mmHg and pulse rate >= 100 bpm or =< 40 bpm, at admission
12-Lead electrocardiogram (ECG) showing a QTcF > 450 millisecond (ms), PR > 215 ms, or QRS > 120 ms
Positive for hepatitis B surface antigen (HBsAg), hepatitis B core antibody, hepatitis C antibody, or human immunodeficiency virus (HIV) I and II tests at screening
Other protocol defined exclusion criteria could apply