Effect of Meal Composition and Timing on Evobrutinib Bioavailability
Effect of Meal Composition and Timing on Evobrutinib Bioavailability
This study will evaluate the Pharmacokinetics (PK) of the Phase II tablet formulation of
 Evobrutinib under fasted conditions, within 30 minutes after start of a light meal, one hour
 prior to start of a low-fat meal, and 2 hours after start of a low-fat meal.
Inclusion Criteria:

 -  Participants are overtly healthy as medical evaluation, including medical history,
 physical examination, laboratory tests, and cardiac monitoring

 -  Participants are stable non-smokers for at least 3 months preceding screening

 -  Male or female participants agree to be consistent with local regulations on
 contraception methods

 -  Female participants are not pregnant or breastfeeding, and at least one of the
 following condition applies:

 -  Not a woman of childbearing potential (WOCBP) or

 -  If a WOCBP, use a highly effective contraceptive method (that is, with a failure rate
 of less than (<) 1 percent per year, preferably with low user dependency for the
 following time period:

 -  Before the first dose of the study intervention, if using hormonal contraception:

 -  Has completed at least one 4-week cycle of an oral contraception pill and either had
 or has begun her menses or

 -  Has used a depot contraceptive or extended-cycle oral contraceptive for least 28 days
 and has a documented negative pregnancy test using a highly sensitive assay and

 -  A barrier method

 -  During the intervention period

 -  After the study intervention period (that is after the last dose of study intervention
 is administered) for at least 90 days, plus 30 days (a menstrual cycle) after the last
 dose of study intervention and agree not to donate eggs (ova, oocytes) for
 reproduction during this period. The Investigator evaluates the effectiveness of the
 contraceptive method in relationship to the first dose of study intervention

 -  Females have a negative serum pregnancy test at the Screening Visit and within 24
 hours before the first dose of study intervention If a urine test cannot be confirmed
 as negative (example: an ambiguous result), a serum pregnancy test is required

 -  The Investigator reviews the medical history, menstrual history, and recent sexual
 activity to decrease the risk for inclusion of a female with an early undetected
 pregnancy

 -  Male participants should agree to the following during the study intervention period
 and for at least 3 months

 -  after the last dose of study intervention:

 -  Refrain from donating sperm,

 -  plus either:

 -  Abstain from intercourse with a female, Or

 -  use a male condom:

 -  When having sexual intercourse with a WOCBP, who is not currently pregnant, and advise
 her to use a highly effective contraceptive method with a failure rate of <1 percent
 per year, since a condom may break or leak

 -  Other protocol defined inclusion criteria could apply

 Exclusion Criteria:

 -  History or presence of clinically relevant respiratory, gastrointestinal, renal,
 hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric,
 musculoskeletal, genitourinary, immunological, dermatological, connective tissue
 diseases or disorders.

 -  Prior history of cholecystectomy or splenectomy, and any clinically relevant surgery
 within 6 months prior to screening

 -  History of any malignancy

 -  History of chronic or recurrent acute infection or any bacterial, viral, parasitic or
 fungal infections within 30 days prior to screening and at any time between screening
 and admission, or hospitalization due to infection within 6 months prior to screening

 -  History of shingles within 12 months prior to screening

 -  History of drug hypersensitivity, ascertained or presumptive allergy/hypersensitivity
 to the active drug substance and/or formulation ingredients

 -  History of alcoholism or drug abuse within 2 years prior to screening, or evidence of
 such abuse as indicated by the laboratory assays conducted during screening

 -  History of residential exposure to tuberculosis, or a positive QuantiFERON® test
 within 4 weeks prior to screening

 -  Administration of live vaccines or live-attenuated virus vaccines within 3 months
 prior to screening

 -  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

 -  Other protocol defined exclusion criteria could apply