Repinatrabit's effects on common medicines like birth control, metformin, carbamazepine, rosuvastatin, and methotrexate

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1 interventional drug–drug interaction trial in healthy volunteers designed to measure how repinatrabit affects the blood levels and behavior of several commonly used medicines. Participants receive repinatrabit together with each listed concomitant medication in controlled clinic visits while investigators collect blood samples, ECGs, and routine labs to monitor drug concentrations and safety. The trial enrolls adults with BMI 18–35 kg/m2 who pass screening exams and laboratory tests; one arm specifically enrolls biological females for the ethinyl estradiol/norethindrone pairing. Safety follow-up includes clinic observation and telephone contact after dosing.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Body mass index (BMI) from 18 to 35 kilograms per square meter (kg/m\^2) (inclusive).
2. Male and female (of non-childbearing potential) assigned at birth, inclusive of all gender identities. Arm 1 will only recruit biological females.
3. In good health as determined by:

   1. Medical history
   2. Physical examination
   3. ECG
   4. Serum chemistry, urinalysis, hematology, and serology tests
4. Willing to stay in the clinic for the required period and willing to be contacted for the safety follow-up via telephone contact.
5. 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:

1. Female participants of childbearing potential.
2. Female participants who have used HRT within 60 days or hormonal contraceptives within 14 days prior to Day 1 (Arm 1 only).
3. 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.
4. 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's running

• Nucleus Network
  Melbourne, Victoria, Australia Recruiting

Study contacts

• Study coordinator: Otsuka Call Center
• Email: Otsuka-ProfessionalServices@otsuka-us.com
• Phone: 844-687-8522

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.