Actively Recruiting
A Trial to Examine the Interaction of Repinatrabit With Ethinyl Estradiol/Norethindrone, Metformin,Carbamazepine, Rosuvastatin, and Methotrexate When Administered Together
Led by Otsuka Pharmaceutical Development & Commercialization, Inc. · Updated on 2026-05-06
48
Participants Needed
1
Research Sites
10 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Trial to Examine the Interaction of Repinatrabit With Ethinyl Estradiol/Norethindrone, Metformin,Carbamazepine, Rosuvastatin, and Methotrexate When Administered Together
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 exam, ECG, serum chemistry, urinalysis, hematology, and serology tests
- Willing to stay in the clinic for the required period and be contacted for safety follow-up
- Ability to provide written informed consent and comply with trial requirements
You will not qualify if you...
- Female participants of childbearing potential
- Female participants who used hormone replacement therapy within 60 days or hormonal contraceptives within 14 days prior to Day 1 (Arm 1 only)
- Clinically significant abnormalities in medical history or screening physical exam that may increase risk or interfere with drug metabolism, including cardiac, hepatic, renal, neurologic, endocrine, gastrointestinal, respiratory, hematologic, immunologic diseases or cholecystectomy
- For Arm 3, positive test for HLA haplotypes associated with carbamazepine-induced hypersensitivity (HLA-B15:02, HLA-A31:01, HLA-B*15:11)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Nucleus Network
Melbourne, Victoria, Australia, 3004
Actively Recruiting
Research Team
O
Otsuka Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
4
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