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A Trial to Examine the Interaction of Repinatrabit With Ethinyl Estradiol/Norethindrone, Metformin,Carbamazepine, Rosuvastatin, and Methotrexate When Administered Together
Study Identifier:
359-201-00015
ClinicalTrials.gov Identifier:
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information:
Recruiting
Study Details
Medical Condition
- Healthy Volunteers
Study Drug
- Drug: Repinatrabit
- Drug: EE/NE
- Drug: Metformin
- Drug: Rosuvastatin
- Drug: Methotrexate
- Drug: Carbamazepine
Date
Mar 2026 - Jun 2026
Phase 1/2
Phase 2/3
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 55 Years
Requirements Information
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.
Protocol 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.
Study Locations
Location
Status
Location
Nucleus Network
Melbourne, Victoria, Australia, 3004
Status
Recruiting
© 2025 Otsuka America Pharmaceutical,
Inc All rights reserved.
July 2025 01US25EUC0279
Requirements information
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.