[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100547727":3},{"organization":4,"armGroups":7,"interventions":38,"overallOfficials":44,"centralContacts":11,"locations":48,"responsibleParty":62,"collaborators":11,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":11,"eligibilityCriteria":70,"healthyVolunteers":71,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":11,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":94,"whyStopped":11,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Celgene","INDUSTRY",[8,14,17,20,23,26,29,32,35],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1A","EXPERIMENTAL",null,[13],"Drug: BMS-986368",{"label":15,"type":10,"description":11,"interventionNames":16},"Cohort 1B",[13],{"label":18,"type":10,"description":11,"interventionNames":19},"Cohort 1C",[13],{"label":21,"type":10,"description":11,"interventionNames":22},"Cohort 2A",[13],{"label":24,"type":10,"description":11,"interventionNames":25},"Cohort 2B",[13],{"label":27,"type":10,"description":11,"interventionNames":28},"Cohort 2C",[13],{"label":30,"type":10,"description":11,"interventionNames":31},"Cohort 2D",[13],{"label":33,"type":10,"description":11,"interventionNames":34},"Cohort 3A",[13],{"label":36,"type":10,"description":11,"interventionNames":37},"Cohort 3B",[13],[39],{"type":40,"name":41,"description":42,"armGroupLabels":43,"otherNames":11},"DRUG","BMS-986368","Specified dose on specified days",[9,15,18,21,24,27,30,33,36],[45],{"name":46,"affiliation":46,"role":47},"Bristol-Myers Squibb","STUDY_DIRECTOR",[49],{"facility":50,"status":11,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":11},"Local Institution - 0001","Anaheim","California","92780","United States","US",{"type":57,"coordinates":58},"Point",[59,60],-117.9145,33.83529,{"lat":60,"lon":59},{"type":63,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100547727","phase-1-a-study-to-evaluate-the-safety-tolerability-and-drug-levels-of-orally-administered-bms-986368-in-healthy-participants-healthy-elderly-participants-and-healthy-participants-of-japanese-ethnicity-100547727",false,"NCT06411730","A Study to Evaluate the Safety, Tolerability, and Drug Levels of Orally Administered BMS-986368 in Healthy Participants, Healthy Elderly Participants, and Healthy Participants of Japanese Ethnicity","A Phase 1, Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Orally Administered BMS-986368 in Healthy Participants, Healthy Elderly Participants, and Healthy Participants of Japanese Ethnicity","Inclusion Criteria\n\n* Participants must be healthy male or non-pregnant and non-nursing female individuals.\n* For Part 2 only, participants must be of Japanese ethnicity (both biological parents are ethnically Japanese).\n* Participants must have a body mass index (BMI) of 18.0 kg\u002Fm2 to 33.0 kg\u002Fm2, inclusive.\n* Participants must have normal renal function at screening.\n\nExclusion Criteria\n\n* Participants must not have a personal or first-degree family (individual's parents, siblings, and children) history of clinically significant psychiatric disorder, including, but not limited to, schizophrenia, psychosis, bipolar disorder, panic disorder, generalized anxiety disorder, and obsessive-compulsive disorder.\n* Participants must not have any significant acute or chronic neurological illness (eg, history of intracranial or intraspinal hemorrhage, CNS lesions, recent bacterial or fungal meningitis, etc) as determined by the investigator.\n* Participants must not have a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, peripheral vascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary (GU) abnormalities\u002Fdiseases including but not limited to peptic ulcer disease, or significant GI bleeding, pancreatitis, hypokalemia.\n* Participants must not have had a SARS-CoV-2 infection within 2 weeks prior to screening.\n* Participants must not have a history of any significant drug allergy or hypersensitivity (such as anaphylaxis or hepatotoxicity).\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.",true,"ALL","18 Years","80 Years",{"count":76,"type":77},56,"ACTUAL","INTERVENTIONAL",[80],"PHASE1","The purpose of this study is to evaluate the safety, tolerability, and drug levels of orally administered BMS-986368 in healthy participants, healthy elderly participants, and healthy participants of japanese ethnicity.",[83],"Healthy Participants",[85,86,41,87,88,89,90,91,83,92,93],"Pharmacokinetics","Pharmacodynamics","CC-97489","Healthy Volunteers","Elderly Volunteers","Japanese Volunteers","Multiple Ascending Dose","Elderly Participants","Japanese Participants","COMPLETED","2024-11-11",{"date":97,"type":77},"2024-11-12",{"date":99,"type":77},"2024-05-31",{"date":101,"type":77},"2024-10-28",{"name":5,"class":6},1]