[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611607":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":44,"centralContacts":48,"locations":56,"responsibleParty":75,"collaborators":11,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":11,"eligibilityCriteria":83,"healthyVolunteers":84,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":11,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":97,"overallStatus":59,"whyStopped":11,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"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",[29,36,41],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DRUG","BMS-986365","Specified dose on specified days",[9,16,19,22,25],[35],"AR-LDD, CC-94676",{"type":30,"name":37,"description":32,"armGroupLabels":38,"otherNames":39},"Itraconazole",[9,19],[40],"SPORANOX®",{"type":30,"name":42,"description":32,"armGroupLabels":43,"otherNames":11},"Rifampin",[25],[45],{"name":46,"affiliation":46,"role":47},"Bristol-Myers Squibb","STUDY_DIRECTOR",[49,54],{"name":50,"role":51,"phone":52,"phoneExt":11,"email":53},"BMS Clinical Trials Contact Center www.BMSClinicalTrials.com","CONTACT","855-907-3286","Clinical.Trials@bms.com",{"name":55,"role":51,"phone":11,"phoneExt":11,"email":11},"First line of the email MUST contain the NCT# and Site #.",[57],{"facility":58,"status":59,"city":60,"state":61,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":71},"Syneos Health Clinic","RECRUITING","Miami","Florida","33136","United States","US",{"type":66,"coordinates":67},"Point",[68,69],-80.19366,25.77427,{"lat":69,"lon":68},[72],{"name":73,"role":51,"phone":74,"phoneExt":11,"email":11},"David Wyatt, Site 0001","305-547-5857",{"type":76,"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":89,"type":90},42,"ESTIMATED","INTERVENTIONAL",[93],"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.",[96],"Healthy Volunteers",[98,31,99,37,42,100,101,102],"Healthy male volunteers","CC-94676","Pharmacokinetics","Crossover","Open-label","2025-12-18",{"date":105,"type":106},"2025-12-24","ACTUAL",{"date":108,"type":106},"2025-12-15",{"date":110,"type":90},"2026-06-14",{"name":5,"class":6},1]