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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorOtsuka Pharmaceutical Development & Commercialization, Inc.

About this trial

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 criteria

Qualifiers

Body mass index (BMI) from 18 to 35 kilograms per square meter (kg/m²) (inclusive).

Male and female (of non-childbearing potential) assigned at birth, inclusive of all gender identities. Arm 1 will only recruit biological females.

Medical history

Physical examination

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • Repinatrabit
  • EE/NE
  • Metformin
  • Rosuvastatin
  • Methotrexate
  • Carbamazepine

Treatment groups

48 Participants
are divided into 4 treatment groups