[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100581558":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":33,"centralContacts":11,"locations":36,"responsibleParty":50,"collaborators":11,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":11,"eligibilityCriteria":58,"healthyVolunteers":59,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":11,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":77,"whyStopped":11,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Bristol-Myers Squibb","INDUSTRY",[8,14,17,20],{"label":9,"type":10,"description":11,"interventionNames":12},"BMS-986165 Formulation 1","EXPERIMENTAL",null,[13],"Drug: Deucravacitinib",{"label":15,"type":10,"description":11,"interventionNames":16},"BMS-986165 Formulation 2",[13],{"label":18,"type":10,"description":11,"interventionNames":19},"BMS-986165 Formulation 2 + Fed",[13],{"label":21,"type":10,"description":11,"interventionNames":22},"BMS-986165 Formulation 2 + Famotidine",[13,23],"Drug: Famotidine",[25,30],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":11},"DRUG","Deucravacitinib","Specified dose on specified days",[9,15,21,18],{"type":26,"name":31,"description":28,"armGroupLabels":32,"otherNames":11},"Famotidine",[21],[34],{"name":5,"affiliation":5,"role":35},"STUDY_DIRECTOR",[37],{"facility":38,"status":11,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":11},"Local Institution - 0001","Austin","Texas","78744","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-97.74306,30.26715,{"lat":48,"lon":47},{"type":51,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100581558","phase-1-a-study-to-evaluate-the-bioequivalence-between-immediate-release-tablets-and-minitablets-of-deucravacitinib-bms-986165-and-the-effect-of-food-and-ph-on-the-drug-levels-of-the-minitablets-in-healthy-adults-100581558",false,"NCT06851871","A Study to Evaluate the Bioequivalence Between Immediate Release Tablets and Minitablets of Deucravacitinib (BMS-986165), and the Effect of Food and pH on the Drug Levels of the Minitablets in Healthy Adults","A Phase 1, Open-label, Single-dose Study in Healthy Adult Participants to Assess the Bioequivalence Between Immediate Release Tablets and Minitablets, and to Assess the Food and pH Effect on the Pharmacokinetics of Deucravacitinib (BMS-986165) Administered as Minitablets","Inclusion Criteria\n\n* Participants must be healthy as determined by no clinically significant deviation from normal in medical history, physical examination, vital signs, 12-lead ECGs, and clinical laboratory determinations in the opinion of the investigator.\n* Participants must be willing and able to complete all study-specific procedures and visits.\n* Participants must have a body mass index of 18.0 kg\u002Fm2 through 32.0 kg\u002Fm2, inclusive, and total body weight ≥ 50 kg (110 lb).\n\nExclusion Criteria\n\n* Participants must not have any significant acute or chronic medical illness that presents a potential risk to the participant and\u002For may compromise the objectives of the study, including a history of\u002For acute liver disease in the opinion of the Investigator.\n* Participants must not have evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, 12-lead ECG, or clinical laboratory determinations beyond what is consistent with the population reference ranges in the opinion of the investigator.\n* Participants must not have any history of severe reaction to a drug (eg, anaphylactic, anaphylactoid, Stevens-Johnson, angioedematous), or adverse or allergic\u002Fhypersensitivity reaction to multiple drugs.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.",true,"ALL","18 Years","55 Years",{"count":64,"type":65},26,"ACTUAL","INTERVENTIONAL",[68],"PHASE1","The purpose of this study is to evaluate the bioequivalence between immediate release tablets and minitablets of Deucravacitinib (BMS-986165), and the effect of food and pH on the drug levels of the minitablets in healthy adults.",[71],"Healthy Participants",[73,74,75,76,27],"Bioequivalence","Food Effect","pH Effect","Healthy Volunteers","COMPLETED","2025-04-28",{"date":80,"type":65},"2025-04-29",{"date":82,"type":65},"2025-01-23",{"date":84,"type":65},"2025-04-04",{"name":5,"class":6},1]