[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611607":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":45,"centralContacts":11,"locations":49,"responsibleParty":63,"collaborators":11,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":11,"eligibilityCriteria":71,"healthyVolunteers":72,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":11,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":90,"whyStopped":91,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Celgene","INDUSTRY",[8,15,18,21,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Part A (Safety Lead-in Group)","EXPERIMENTAL",null,[13,14],"Drug: BMS-986365","Drug: Itraconazole",{"label":16,"type":10,"description":11,"interventionNames":17},"Part A, Period 1",[13],{"label":19,"type":10,"description":11,"interventionNames":20},"Part A, Period 2",[13,14],{"label":22,"type":10,"description":11,"interventionNames":23},"Part B, Period 1",[13],{"label":25,"type":10,"description":11,"interventionNames":26},"Part B, Period 2",[13,27],"Drug: Rifampin",[29,37,42],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DRUG","BMS-986365","Specified dose on specified days",[9,16,19,22,25],[35,36],"AR-LDD","CC-94676",{"type":30,"name":38,"description":32,"armGroupLabels":39,"otherNames":40},"Itraconazole",[9,19],[41],"SPORANOX®",{"type":30,"name":43,"description":32,"armGroupLabels":44,"otherNames":11},"Rifampin",[25],[46],{"name":47,"affiliation":47,"role":48},"Bristol-Myers Squibb","STUDY_DIRECTOR",[50],{"facility":51,"status":11,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":11},"Local Institution - 0001","Miami","Florida","33136","United States","US",{"type":58,"coordinates":59},"Point",[60,61],-80.19366,25.77427,{"lat":61,"lon":60},{"type":64,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100611607","phase-1-a-study-to-evaluate-the-effect-of-itraconazole-and-rifampin-on-the-drug-levels-of-ar-ldd-bms-986365-in-healthy-adult-male-participants-100611607",false,"NCT07242781","A Study to Evaluate the Effect of Itraconazole and Rifampin on the Drug Levels of AR-LDD (BMS-986365) in Healthy Adult Male Participants","A Phase 1, Open-label, 2-part, Fixed-sequence, Crossover Study to Evaluate the Effect of Cytochrome P450 (CYP) 3A Inhibitor (Itraconazole) and Inducer (Rifampin) on the Pharmacokinetics of AR-LDD (BMS-986365) in Healthy Adult Male Participants","Inclusion Criteria\n\n* Participants must be male, at the time of signing the Informed Consent Form (ICF), have a Body Mass Index (BMI) of 18.0 to 32.0 kg\u002Fm2; and healthy as determined by medical history, PE, vital signs, 12-lead ECG, transthoracic echocardiogram (TTE) and clinical laboratory assessments.\n\nExclusion Criteria\n\n* Participants must not have any significant or chronic illness.\n* Participants must not have a prior history of heart failure, ischemic heart diseases, serious cardiac arrythmias, or prolonged QT interval.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.",true,"MALE","18 Years","60 Years",{"count":77,"type":78},22,"ACTUAL","INTERVENTIONAL",[81],"PHASE1","The purpose of this study is to evaluate the effect of Itraconazole and Rifampin on the drug levels of AR-LDD (BMS-986365) in healthy adult male participants.",[84],"Healthy Volunteers",[86,31,36,38,43,87,88,89],"Healthy male volunteers","Pharmacokinetics","Crossover","Open-label","TERMINATED","Business objectives have changed","2026-07-17",{"date":94,"type":78},"2026-07-20",{"date":96,"type":78},"2025-12-15",{"date":98,"type":78},"2026-04-21",{"name":5,"class":6},1]