[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611607":3},{"organization":4,"outcomesModule":7,"designInfo":69,"detailedDescription":11,"studyPopulation":11,"armGroups":75,"interventions":95,"overallOfficials":111,"centralContacts":115,"locations":123,"responsibleParty":142,"collaborators":11,"id":144,"slug":11,"hasResults":145,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":11,"eligibilityCriteria":149,"healthyVolunteers":150,"sex":151,"minAge":152,"maxAge":153,"enrollmentInfo":154,"targetDuration":11,"studyType":157,"phases":158,"briefSummary":160,"conditions":161,"keywords":163,"overallStatus":126,"whyStopped":11,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":178},{"fullName":5,"class":6},"Celgene","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":36,"otherOutcomes":11},[9,13,15,17,19,21,23,26,28,30,32,34],{"measure":10,"description":11,"timeFrame":12},"Part A: Maximum Observed Plasma Concentration (Cmax) of BMS-986365",null,"Up to approximately Day 32",{"measure":14,"description":11,"timeFrame":12},"Part A: Cmax of BMS-986365 Without Itraconazole",{"measure":16,"description":11,"timeFrame":12},"Part A: Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) of BMS-986365 With Itraconazole",{"measure":18,"description":11,"timeFrame":12},"Part A: AUC(0-T) of BMS-986365 Without Itraconazole",{"measure":20,"description":11,"timeFrame":12},"Part A: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) of BMS-986365",{"measure":22,"description":11,"timeFrame":12},"Part A: AUC(INF) of BMS-986365 Without Itraconazole",{"measure":24,"description":11,"timeFrame":25},"Part B: Cmax of BMS-986365 With Rifampin","Up to approximately Day 37",{"measure":27,"description":11,"timeFrame":25},"Part B: Cmax of BMS-986365 Without 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#.",[124],{"facility":125,"status":126,"city":127,"state":128,"zip":129,"country":130,"countryCode":131,"cosmosGeoPoint":132,"geoPoint":137,"contacts":138},"Syneos Health Clinic","RECRUITING","Miami","Florida","33136","United States","US",{"type":133,"coordinates":134},"Point",[135,136],-80.19366,25.77427,{"lat":136,"lon":135},[139],{"name":140,"role":118,"phone":141,"phoneExt":11,"email":11},"David Wyatt, Site 0001","305-547-5857",{"type":143,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","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":155,"type":156},42,"ESTIMATED","INTERVENTIONAL",[159],"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.",[162],"Healthy Volunteers",[164,98,165,104,109,166,167,168],"Healthy male volunteers","CC-94676","Pharmacokinetics","Crossover","Open-label","2025-12-18",{"date":171,"type":172},"2025-12-24","ACTUAL",{"date":174,"type":172},"2025-12-15",{"date":176,"type":156},"2026-06-14",{"name":5,"class":6},1]