DDI Study of Evobrutinib and Carbamazepine
- Registration Number
- NCT05248945
- Lead Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 14
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Evobrutinib plus Carbamazepine Evobrutinib - Evobrutinib plus Carbamazepine Carbamazepine -
- Primary Outcome Measures
Name Time Method Area Under the Plasma Concentration-Time Curve (AUC) from Time Zero Extrapolated to Infinity (AUC0-inf) of Evobrutinib Pre-dose up to 24 hours post-dose on Day 1 and 19 Maximum Observed Plasma Concentration (Cmax) of Evobrutinib Pre-dose up to 24 hours post-dose on Day 1 and 19
- Secondary Outcome Measures
Name Time Method Number of Participants with Treatment-emergent Adverse Events (TEAEs) Based on Severity Baseline up to Day 26 Number of Participants with Abnormal Laboratory Variables, Vital Signs and 12-Lead Electrocardiogram (ECG) Measurements Baseline up to Day 26 Pharmacokinetic Plasma Concentrations of Evobrutinib and MSC2729909A Pre-dose up to 24 hours post-dose on Day 1 and 19
Trial Locations
- Locations (1)
Nuvisan GmbH
🇩🇪Neu-Ulm, Bavaria, Germany