DDI Study of Evobrutinib and Carbamazepine

Merck KGaA (EMD Serono)

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Evobrutinib

Drug: Carbamazepine

Study type

Interventional

Funder types

Industry

Identifiers

NCT05248945

MS200527_0108

2021-003381-13 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to investigate the effect of multiple doses of carbamazepine on two single doses of evobrutinib pharmacokinetics (PK) in healthy participants. Study details include:

Study Duration: up to 54 days. Treatment Duration: 25 days. Visit Frequency: Participants will be resident in the Clinical Research Unit from Day 1 to Day 20 and return on Day 26 for a Safety Follow-Up visit.

Enrollment

14 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Type of Participant and Disease Characteristics
Have a body weight within 50.0 and 100.0 kg (kilogram) (inclusive) and Body Mass Index (BMI) within the range 19.0 and 30.0 kilogram per meter square (kg/m^2) (inclusive)
Male: No contraception and barrier requirements needed. Female: Is not a woman of childbearing potential
Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the Informed Consent Form (ICF) and this protocol
Are stable nonsmokers for at least 3 months preceding Screening

Exclusion criteria

History or presence of clinically relevant respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, musculoskeletal, genitourinary, immunological, dermatological, connective tissue, psychiatric (due to rare risk of hallucinations, agitation and activation of psychosis), and other diseases or disorders, and epilepsy, as determined by medical evaluation
Administration of live vaccines or live-attenuated virus vaccines within 3 months prior to Screening. Administration of other types of vaccines (e.g., SARSCoV2 vaccines) is allowed until 2 weeks before admission to Clinical Research Unit (CRU), thereafter it is prohibited until the end of the study
Moderate or strong inhibitors or inducers of Cytochrome P450 (CYP)3A4/5 or Pgp within 4 weeks prior to the first administration of study intervention
Contraindication to carbamazepine (carbamazepine SmPC)
History of any malignancy
History of drug hypersensitivity ascertained or presumptive allergy/hypersensitivity to the active drug substance and/or formulation ingredients; history of serious allergic reactions leading to hospitalization or any other hypersensitivity reaction in general, including contact hypersensitivity to Electrocardiogram (ECG) electrodes, which may affect the safety of the participant and/or outcome of the study per the Investigator's discretion.
Other protocol defined exclusion criteria could apply.