A Trial to Examine the Interaction of Repinatrabit With Ethinyl Estradiol/Norethindrone, Metformin,Carbamazepine, Rosuvastatin, and Methotrexate When Administered Together
A Phase 1, 4-arm, Open-label, Drug-drug Interaction Trial to Evaluate the Pharmacokinetics of Repinatrabit Oral Tablets When Co-administered With Ethinyl Estradiol/Norethindrone, Metformin, Carbamazepine, Rosuvastatin, and Methotrexate in Healthy Participants
Otsuka Pharmaceutical Development & Commercialization, Inc.
48 participants
Mar 31, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria9
- 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 Criteria4
- 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).
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Interventions
Oral tablet.
Oral tablet.
Oral tablet.
Oral tablet.
Oral tablet.
Oral tablet.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07446400