[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100627266":3},{"organization":4,"armGroups":7,"interventions":31,"overallOfficials":42,"centralContacts":55,"locations":61,"responsibleParty":79,"collaborators":42,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":42,"eligibilityCriteria":87,"healthyVolunteers":88,"sex":89,"minAge":90,"maxAge":91,"enrollmentInfo":92,"targetDuration":42,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":101,"overallStatus":64,"whyStopped":42,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"Otsuka Pharmaceutical Development & Commercialization, Inc.","INDUSTRY",[8,15,21,26],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 1: Repinatrabit + EE\u002FNE","EXPERIMENTAL","Participants will first receive a single dose of EE\u002FNE, orally, followed by repinatrabit in combination with EE\u002FNE or alone, up to Day 18.",[13,14],"Drug: Repinatrabit","Drug: EE\u002FNE",{"label":16,"type":10,"description":17,"interventionNames":18},"Arm 2: Repinatrabit + (Metformin + Rosuvastatin)","Participants will receive a single dose of metformin and rosuvastatin, orally, followed by repinatrabit in combination with metformin and rosuvastatin or alone, up to Day 9.",[13,19,20],"Drug: Metformin","Drug: Rosuvastatin",{"label":22,"type":10,"description":23,"interventionNames":24},"Arm 3: Repinatrabit + Carbamazepine","Participants will receive a single dose of repinatrabit, orally, followed by carbamazepine in combination with repinatrabit or alone, up to Day 15.",[13,25],"Drug: Carbamazepine",{"label":27,"type":10,"description":28,"interventionNames":29},"Arm 4: Repinatrabit + Methotrexate","Participants will receive a single dose of methotrexate, orally, followed by repinatrabit in combination with methotrexate or alone, up to Day 8.",[13,30],"Drug: Methotrexate",[32,39,43,46,49,52],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"DRUG","Repinatrabit","Oral tablet.",[9,16,22,27],[38],"JNT517",{"type":33,"name":40,"description":35,"armGroupLabels":41,"otherNames":42},"EE\u002FNE",[9],null,{"type":33,"name":44,"description":35,"armGroupLabels":45,"otherNames":42},"Metformin",[16],{"type":33,"name":47,"description":35,"armGroupLabels":48,"otherNames":42},"Rosuvastatin",[16],{"type":33,"name":50,"description":35,"armGroupLabels":51,"otherNames":42},"Methotrexate",[27],{"type":33,"name":53,"description":35,"armGroupLabels":54,"otherNames":42},"Carbamazepine",[22],[56],{"name":57,"role":58,"phone":59,"phoneExt":42,"email":60},"Otsuka Call Center","CONTACT","844-687-8522","Otsuka-ProfessionalServices@otsuka-us.com",[62],{"facility":63,"status":64,"city":65,"state":66,"zip":67,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":75,"contacts":76},"Nucleus Network","RECRUITING","Melbourne","Victoria","3004","Australia","AU",{"type":71,"coordinates":72},"Point",[73,74],144.96332,-37.814,{"lat":74,"lon":73},[77],{"name":78,"role":58,"phone":59,"phoneExt":42,"email":60},"Gonan",{"type":80,"investigatorFullName":42,"investigatorTitle":42,"investigatorAffiliation":42,"oldNameTitle":42,"oldOrganization":42},"SPONSOR","100627266","phase-1-a-trial-to-examine-the-interaction-of-repinatrabit-with-ethinyl-estradiolnorethindrone-metformincarbamazepine-rosuvastatin-and-methotrexate-when-administered-together-100627266",false,"NCT07446400","A Trial to Examine the Interaction of Repinatrabit With Ethinyl Estradiol\u002FNorethindrone, 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\u002FNorethindrone, Metformin, Carbamazepine, Rosuvastatin, and Methotrexate in Healthy Participants","Inclusion Criteria:\n\n1. Body mass index (BMI) from 18 to 35 kilograms per square meter (kg\u002Fm\\^2) (inclusive).\n2. Male and female (of non-childbearing potential) assigned at birth, inclusive of all gender identities. Arm 1 will only recruit biological females.\n3. In good health as determined by:\n\n   1. Medical history\n   2. Physical examination\n   3. ECG\n   4. Serum chemistry, urinalysis, hematology, and serology tests\n4. Willing to stay in the clinic for the required period and willing to be contacted for the safety follow-up via telephone contact.\n5. 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.\n\nExclusion Criteria:\n\n1. Female participants of childbearing potential.\n2. Female participants who have used HRT within 60 days or hormonal contraceptives within 14 days prior to Day 1 (Arm 1 only).\n3. 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.\n4. 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).\n\nNote: Other protocol-specified Inclusion\u002FExclusion criteria may apply.",true,"ALL","18 Years","55 Years",{"count":93,"type":94},48,"ESTIMATED","INTERVENTIONAL",[97],"PHASE1","The purpose of this study is to assess the drug-drug interaction (DDI) of repinatrabit with ethinyl estradiol\u002Fnorethindrone or norethisterone (EE\u002FNE), metformin, rosuvastatin, carbamazepine, and methotrexate in healthy participants.",[100],"Healthy Volunteers",[102,103],"Phenylketonuria","Drug-Drug Interaction (DDI) study","2026-05-05",{"date":106,"type":107},"2026-05-06","ACTUAL",{"date":109,"type":107},"2026-03-31",{"date":111,"type":94},"2026-06-15",{"name":5,"class":6},1]