[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100433586":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":38,"centralContacts":33,"locations":41,"responsibleParty":55,"collaborators":33,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":33,"eligibilityCriteria":63,"healthyVolunteers":64,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":33,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":78,"whyStopped":33,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Bristol-Myers Squibb","INDUSTRY",[8,15,19,23],{"label":9,"type":10,"description":11,"interventionNames":12},"Part A: SAD","EXPERIMENTAL","SAD = Single Ascending Dose",[13,14],"Drug: BMS-986172","Other: Placebo",{"label":16,"type":10,"description":17,"interventionNames":18},"Part B: MAD","MAD = Multiple Ascending Dose",[13,14],{"label":20,"type":10,"description":21,"interventionNames":22},"Part C: JMAD","JMAD= Japanese Multiple Ascending Dose",[13,14],{"label":24,"type":10,"description":25,"interventionNames":26},"Part D: FE\u002FBA","FE\u002FBA = Food Effect\u002FRelative Bioavailability",[13],[28,34],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"DRUG","BMS-986172","Specified dose on specified days",[9,16,20,24],null,{"type":35,"name":36,"description":31,"armGroupLabels":37,"otherNames":33},"OTHER","Placebo",[9,16,20],[39],{"name":5,"affiliation":5,"role":40},"STUDY_DIRECTOR",[42],{"facility":43,"status":33,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":33},"ICON Plc (Legacy PRA)","Lenexa","Kansas","66215","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-94.73357,38.95362,{"lat":53,"lon":52},{"type":56,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR","100433586","phase-1-a-study-to-assess-the-safety-tolerability-and-drug-levels-of-bms-986172-in-healthy-and-obese-participants-including-an-assessment-of-the-effects-of-food-on-bms-986172-absorption-100433586",false,"NCT04926051","A Study to Assess the Safety, Tolerability and Drug Levels of BMS-986172 in Healthy and Obese Participants, Including an Assessment of the Effects of Food on BMS-986172 Absorption","A Phase 1, Double-blind, Placebo-controlled, Randomized, Single and Multiple Ascending Dose, and a Japanese Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of BMS-986172, Including an Open-Label Assessment of Relative Bioavailability and Food Effect on the Single-Dose Pharmacokinetics of BMS-986172 in Healthy and Obese Otherwise Healthy Participants","Inclusion Criteria:\n\n* Healthy participants as determined by no clinically significant deviation from normal in medical history, physical examination, vital signs, ECG, and clinical laboratory results as determined by the investigator or designee.\n* Participants in Part C must be first-generation Japanese participants. For the purpose of this study, first-generation Japanese is defined as native Japanese or first-generation Japanese living outside of Japan for \\\u003C10 years.\n* BMI of ≥ 18 kg\u002Fm2 to ≤ 40.0 kg\u002Fm2, inclusive, at screening, except for high BMI cohort participants (Part B) which will be restricted to a BMI range of ≥ 30 kg\u002Fm2 to ≤ 40.0 kg\u002Fm2.\n\nExclusion Criteria:\n\n* Inability to tolerate the oral lipid meal or the testing conditions on Day -1, including but not limited to: bloating, nausea, vomiting, diarrhea, pain, or any discomfort due to oral lipid meal.\n* Any significant acute or chronic medical condition that presents a potential risk to the participant and\u002For that may compromise the objectives of the study, including active, or history of, liver disease, or intestinal disorder including irritable bowel syndrome.\n* History or presence of malignancy including hematological malignancies; participants with a history of basal cell or squamous cell carcinoma that has been treated with no evidence of recurrence within 5 years will be allowed for inclusion, as judged by the investigator or designee.\n* Any significant acute or chronic medical illness.\n* History of SARS-CoV-2 infection (either suspected or confirmed) within 3 months prior to signing consent\n* Participants who have received a SARS-CoV-2 vaccine approved for Emergency Use Authorization by the US FDA that is not live attenuated may be considered for enrollment\n\nOther protocol-defined inclusion\u002Fexclusion criteria apply",true,"ALL","18 Years","55 Years",{"count":69,"type":70},40,"ACTUAL","INTERVENTIONAL",[73],"PHASE1","The purpose of this study is to evaluate the safety, tolerability and drug levels of BMS-986172 and evaluate the effects of food on BMS-986172 absorption.",[76],"Healthy Participants",[76,30],"COMPLETED","2022-06-02",{"date":81,"type":70},"2022-06-06",{"date":83,"type":70},"2021-06-15",{"date":85,"type":70},"2021-12-28",{"name":5,"class":6},1]