[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100508537":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":33,"centralContacts":11,"locations":36,"responsibleParty":50,"collaborators":11,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":11,"eligibilityCriteria":58,"healthyVolunteers":59,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":11,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":74,"whyStopped":11,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Bristol-Myers Squibb","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Part 1: Afimetoran followed by phenytoin + afimetoran","EXPERIMENTAL",null,[13,14],"Drug: Afimetoran","Drug: Phenytoin",{"label":16,"type":10,"description":11,"interventionNames":17},"Part 2: Midazolam followed by afimetoran + midazolam",[13,18],"Drug: Midazolam",[20,27,30],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Afimetoran","Specified dose on specified days",[9,16],[26],"BMS-986256",{"type":21,"name":28,"description":23,"armGroupLabels":29,"otherNames":11},"Phenytoin",[9],{"type":21,"name":31,"description":23,"armGroupLabels":32,"otherNames":11},"Midazolam",[16],[34],{"name":5,"affiliation":5,"role":35},"STUDY_DIRECTOR",[37],{"facility":38,"status":11,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":11},"Local Institution - 0001","Miami","Florida","33136","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-80.19366,25.77427,{"lat":48,"lon":47},{"type":51,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100508537","phase-1-a-study-to-assess-the-effect-of-phenytoin-on-the-drug-levels-of-afimetoran-and-the-effect-of-afimetoran-on-the-drug-levels-of-midazolam-100508537",false,"NCT05901714","A Study to Assess the Effect of Phenytoin on the Drug Levels of Afimetoran and the Effect of Afimetoran on the Drug Levels of Midazolam","An Open-label, Single-sequence, Drug-drug Interaction Study in Healthy Participants to Assess the Effect of Phenytoin on the Pharmacokinetics of a Single Oral Dose of Afimetoran (BMS-986256) (Part 1) and the Effect of Steady-state Afimetoran on the Pharmacokinetics of Midazolam (Part 2)","Inclusion Criteria:\n\n* Body mass index (BMI) of 19.0 kilograms per meter squared (kg\u002Fm\\^2) to 32.0 kg\u002Fm2, inclusive, and body weight ≥ 55 kg, at screening.\n\nExclusion Criteria:\n\n* Any significant acute or chronic medical illness or any other condition listed as a contraindication in the phenytoin (Part 1) or midazolam (Part 2) package inserts.\n* History of seizure (including simple febrile seizure), epilepsy, severe head injury (including concussion), multiple sclerosis, or other known neurological condition which the investigator considers to be clinically significant.\n* Current or recent (within 3 months of study intervention administration) GI disease that could impact upon the absorption of study intervention.\n\nOther protocol-defined inclusion\u002Fexclusion criteria apply.",true,"ALL","18 Years","55 Years",{"count":64,"type":65},65,"ACTUAL","INTERVENTIONAL",[68],"PHASE1","This study will consist of 2 parts. The study will evaluate whether administration of phenytoin impacts the single-dose drug levels of afimetoran and BMT-271199 (Part 1) and will evaluate whether multiple administrations of afimetoran impact the drug levels of midazolam and 1-hydroxymidazolam (Part 2).",[71],"Healthy Participants",[26,22,31,73,28],"CYP3A4","COMPLETED","2024-08-06",{"date":77,"type":65},"2024-08-07",{"date":79,"type":65},"2023-06-14",{"date":81,"type":65},"2024-04-11",{"name":5,"class":6},1]