Multiple Sclerosis Rheumatoid Arthritis
Conditions
Interventions
Evobrutinib will be given as an oral solution of 30 milliliters (mL) which will
be administered orally in a syringe after an overnight fast (no eating for at
least 10 hours). After administration of
Sponsors
PRA Health Sciences
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. 18-55 years of age at the time of signing the informed consent. 2. Are overtly healthy as determined by medical evaluation, including medical history, physical examination, laboratory tests, and cardiac monitoring. 3. Have a body weight within 50.0 and 120.0 kg (inclusive) and Body Mass Index (BMI) within the range 19.0 - 30.0 kg/m2 (inclusive). 4. Male
Exclusion criteria
Exclusion criteria: 1. History or presence of clinically relevant respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases or disorders. 2. Prior history of cholecystectomy or splenectomy, and any clinically relevant surgery within 6 months prior to screening. 3. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the subject in case of participation in the study. 4. History of any malignancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the rates and routes of excretion of total radioactivity, including mass balance of total drug-related radioactivity in urine and feces To determine the PK of total radioactivity in blood and plasma To characterize the plasma PK of evobrutinib | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the safety and tolerability of a single oral 75 mg dose of [14C]-evobrutinib administered to healthy male participants | — |
Countries
Netherlands
Outcome results
None listed