A Trial to Examine the Interaction of Repinatrabit With Ethinyl Estradiol/Norethindrone, Metformi… (NCT07446400) | Clinical Trial Compass
RecruitingPhase 1
A Trial to Examine the Interaction of Repinatrabit With Ethinyl Estradiol/Norethindrone, Metformin,Carbamazepine, Rosuvastatin, and Methotrexate When Administered Together
Australia48 participantsStarted 2026-03-31
Plain-language 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.
Who can participate
Age range18 Years – 55 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
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.
What they're measuring
1
All Arms: Maximum Plasma Concentration (Cmax)
Timeframe: Arm 1: up to Day 19; Arm 2: up to Day 10; Arm 3: up to Day 16; Arm 4: up to Day 9
2
All Arms: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Observable Concentration at Time t (AUCt)
Timeframe: Arm 1: up to Day 19; Arm 2: up to Day 10; Arm 3: up to Day 16; Arm 4: up to Day 9
3
All Arms: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinfinity)
Timeframe: Arm 1: up to Day 19; Arm 2: up to Day 10; Arm 3: up to Day 16; Arm 4: up to Day 9
Trial details
NCT IDNCT07446400
SponsorOtsuka Pharmaceutical Development & Commercialization, Inc.
. 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).