Clincosm LogoSign in Get a demo

DDI Study of Evobrutinib and Carbamazepine

Sponsor
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany (Industry)
Overall Status
Completed
CT.gov ID
NCT05248945
Collaborator
(none)
14
Enrollment
1
Location
1
Arm
6.1
Actual Duration (Months)
2.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
14 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Phase I, Open-Label, Single-Sequence Study of the Effect of Multiple Doses of Carbamazepine on Single-Dose Evobrutinib Pharmacokinetics in Healthy Participants
Actual Study Start Date :
Jan 13, 2022
Actual Primary Completion Date :
Jul 18, 2022
Actual Study Completion Date :
Jul 18, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Evobrutinib plus Carbamazepine

Drug: Evobrutinib
Participants will receive a single dose of film-coated evobrutinib tablet (TF2) on Day 1 and Day 19.
Other Names:
  • M2951

    • Drug: Carbamazepine
    Participants will receive carbamazepine tablet twice daily from Days 2 to 25.

    Outcome Measures

    Primary Outcome Measures

    1. 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]

    2. Maximum Observed Plasma Concentration (Cmax) of Evobrutinib [Pre-dose up to 24 hours post-dose on Day 1 and 19]

    Secondary Outcome Measures

    1. Number of Participants with Treatment-emergent Adverse Events (TEAEs) Based on Severity [Baseline up to Day 26]

    2. Number of Participants with Abnormal Laboratory Variables, Vital Signs and 12-Lead Electrocardiogram (ECG) Measurements [Baseline up to Day 26]

    3. Pharmacokinetic Plasma Concentrations of Evobrutinib and MSC2729909A [Pre-dose up to 24 hours post-dose on Day 1 and 19]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Nuvisan GmbH Neu-Ulm Bavaria Germany

    Sponsors and Collaborators

    • Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

    Investigators

    • Study Director: Medical Responsible, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
    ClinicalTrials.gov Identifier:
    NCT05248945
    Other Study ID Numbers:
    • MS200527_0108
    • 2021-003381-13
    First Posted:
    Feb 21, 2022
    Last Update Posted:
    Aug 22, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
    Clinical Pharmacology
    Additional relevant MeSH terms:
    Carbamazepine

    Study Results

    No Results Posted as of Aug 22, 2022