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

Recruiting now · Phase 1

Conditions studied: Healthy Volunteers

In brief

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.

Key facts

Study ID

NCT07446400

Run by

Otsuka Pharmaceutical Development & Commercialization, Inc.

People needed

48

Starts

2026-03-31

Expected to finish

2026-06-15

Last updated by the study team

2026-05-06

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Nucleus Network — Melbourne, Victoria, Australia (enrolling)

Full record on ClinicalTrials.gov

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