A Trial to Examine the Interaction of Repinatrabit With Ethinyl Estradiol/Norethindrone, Metformin,Carbamazepine, Rosuvastatin, and Methotrexate When Administered Together

Sponsor ID
359-201-00015
Clinicaltrials.gov ID
NCT07446400
EudraCT ID
N/A
EUCTIS ID
N/A
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information
844-687-8522 or [email protected]
Recruiting
Sponsor ID
359-201-00015
Trial Details
Subscribe for updates
Age
18 - 55 Years
Therapeutic Area
  • Healthy Volunteers
    • Sex
    Female & Male
    Trial Dates
    Mar 2026 - Nov 2026
    Healthy Volunteers
    Yes
    • Body mass index (BMI) from 18 to 35 kilograms per square meter (kg/m\^2) (inclusive).
    • Male and female (of non-childbearing potential) assigned at birth, inclusive of all gender identities. Arm 1 will only recruit biological females.
    • In good health as determined by:
    • Medical history
    • Physical examination
    • ECG
    • Serum chemistry, urinalysis, hematology, and serology tests
    • Willing to stay in the clinic for the required period and willing to be contacted for the safety follow-up via telephone contact.
    • Ability to provide written, informed consent prior to initiation of any trial-related procedures, and ability, in the opinion of the principal investigator, to comply with all the requirements of the trial.
    • Female participants of childbearing potential.
    • Female participants who have used HRT within 60 days or hormonal contraceptives within 14 days prior to Day 1 (Arm 1 only).
    • Clinically significant abnormality in past medical history, or at the screening physical examination, that in the investigator's or sponsor's opinion may place the participant at risk or interfere with outcome variables including absorption, distribution, metabolism, and excretion of drug. This includes, but is not limited to, history of or concurrent cardiac, hepatic, renal, neurologic, endocrine, gastrointestinal, respiratory, hematologic, and immunologic disease or cholecystectomy.
    • For Arm 3, participants who test positive for HLA haplotypes associated with carbamazepine-induced hypersensitivity (HLA-B\*15:02, HLA-A\*31:01, and HLA-B\*15:11).
    • Note: Other protocol-specified Inclusion/Exclusion criteria may apply.

    Study Summary

    The purpose of this study is to assess the drug-drug interaction (DDI) of repinatrabit with ethinyl estradiol/norethindrone or norethisterone (EE/NE), metformin, rosuvastatin, carbamazepine, and methotrexate in healthy participants.

    Additional Study Details

    Phase
    Phase 1
    Study Drug
    Drug: Repinatrabit
    Type
    Interventional
    Masking
    None (Open Label)
    Estimated Enrollment
    48
    Additional Study Details

    Inclusion and Exclusion Criteria

    Inclusion Criteria

    • 1. Body mass index (BMI) from 18 to 35 kilograms per square meter (kg/m\^2) (inclusive).
    • 2. Male and female (of non-childbearing potential) assigned at birth, inclusive of all gender identities. Arm 1 will only recruit biological females.

    Exclusion Criteria

    • 1. Female participants of childbearing potential.
    • 2. Female participants who have used HRT within 60 days or hormonal contraceptives within 14 days prior to Day 1 (Arm 1 only).
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    • Body mass index (BMI) from 18 to 35 kilograms per square meter (kg/m\^2) (inclusive).
    • Male and female (of non-childbearing potential) assigned at birth, inclusive of all gender identities. Arm 1 will only recruit biological females.
    • In good health as determined by:
    • Medical history
    • Physical examination
    • ECG
    • Serum chemistry, urinalysis, hematology, and serology tests
    • Willing to stay in the clinic for the required period and willing to be contacted for the safety follow-up via telephone contact.
    • Ability to provide written, informed consent prior to initiation of any trial-related procedures, and ability, in the opinion of the principal investigator, to comply with all the requirements of the trial.
    Exclusion Criteria:
    • Female participants of childbearing potential.
    • Female participants who have used HRT within 60 days or hormonal contraceptives within 14 days prior to Day 1 (Arm 1 only).
    • Clinically significant abnormality in past medical history, or at the screening physical examination, that in the investigator's or sponsor's opinion may place the participant at risk or interfere with outcome variables including absorption, distribution, metabolism, and excretion of drug. This includes, but is not limited to, history of or concurrent cardiac, hepatic, renal, neurologic, endocrine, gastrointestinal, respiratory, hematologic, and immunologic disease or cholecystectomy.
    • For Arm 3, participants who test positive for HLA haplotypes associated with carbamazepine-induced hypersensitivity (HLA-B\*15:02, HLA-A\*31:01, and HLA-B\*15:11).
    • Note: Other protocol-specified Inclusion/Exclusion criteria may apply.

    Locations

    Location
    Status
    Location
    Nucleus Network
    Melbourne, Victoria, Australia, 3004
    Status
    Recruiting

    © 2026 Otsuka America Pharmaceutical, Inc.

    All rights reserved.

    January 2026 01US25EUC0489

    We defy limitation,

    so that others can too.

    Follow Us
    OAPI and OPDC Locations

    508 Carnegie Center Dr,

    Princeton, NJ 08540, United States

    Phone +1 609-524-6788

    2440 Research Blvd,

    Rockville, MD 20850, United States

    Phone +1 301-424-9055

    3956 Point Eden Way

    Hayward, CA 94545, United States

    Phone +1 800-562-3974