[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07629999":3,"trial-entities:NCT07629999":195,"trial-summary:NCT07629999":198},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":33,"primary_purpose":34,"phases":35,"enrollment_info":37,"interventions":40,"primary_outcomes":60,"secondary_outcomes":78,"sex":146,"minimum_age":147,"maximum_age":148,"healthy_volunteers":149,"eligibility_criteria":150,"std_ages":161,"locations":163,"central_contacts":177,"overall_officials":184,"references":187,"see_also_links":188},"NCT07629999","CN016-0001","Single and Multiple Dose Study to Evaluate Safety and Pharmacokinetics of BMS-986533 in Healthy Participants and Assessments of Food and pH Effects on Relative Bioavailability, and Drug-Drug Interaction Potential in Healthy Participants","A Phase 1, Randomized, Double-blind, Placebo-controlled, First-in-Human, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986533 in Healthy Participants, an Open-label Assessment of Food and pH Effects on the Relative Bioavailability of BMS-986533, and an Open-label Study to Evaluate P-gp- and BCRP-mediated Drug-Drug Interaction Potential of BMS-986533 in Healthy Participants","RECRUITING","2027-06-01","2026-07","2026-07-24","2026-07-13","Bristol-Myers Squibb","INDUSTRY",false,"The purpose of this study is to evaluate the safety and pharmacokinetics of BMS-986533 in healthy participants receiving single and multiple doses, to assess food and pH effects on the relative bioavailability of BMS-986533, and the P-gp and BCRP-mediated drug-drug interaction potential of the study drug",null,[19],"Healthy Volunteers",[21,22,23,24,25,26,27,28,29,30,31,32],"Healthy","BMS-986533","Food effect","pH effect","rBA","DDI","Dabigatran","Rosuvastatin","Fasted","Fed","Single ascending dose","Multiple ascending dose","INTERVENTIONAL","TREATMENT",[36],"PHASE1",{"count":38,"type":39},136,"ESTIMATED",[41,49,52,55,58],{"type":42,"name":22,"description":43,"armGroupLabels":44},"DRUG","Specified dose on specified days",[45,46,47,48],"Arm A","Arm B","Arm C","Arm D",{"type":42,"name":50,"description":43,"armGroupLabels":51},"Famotidine",[47],{"type":42,"name":53,"description":43,"armGroupLabels":54},"Placebo",[45,46],{"type":42,"name":56,"description":43,"armGroupLabels":57},"Dabigatran Etexilate",[48],{"type":42,"name":28,"description":43,"armGroupLabels":59},[48],[61,64,66,69,72,74,76],{"measure":62,"timeFrame":63},"Number of participants with Adverse Events (AE)","Up to Day 47",{"measure":65,"timeFrame":63},"Number of participants with Serious Adverse Events (SAE)",{"measure":67,"timeFrame":68},"Number of participants with Vital Sign Abnormalities","Up to Day 27",{"measure":70,"description":71,"timeFrame":68},"Number of participants with Physical Examination Abnormalities","Including neurological examination",{"measure":73,"timeFrame":68},"Number of participants with Electrocardiogram (ECG) Abnormalities",{"measure":75,"timeFrame":68},"Number of participants with Clinical Laboratory Assessments Abnormalities",{"measure":77,"timeFrame":68},"Number of participants with Treatment-emergent suicidal ideation and behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)",[79,82,84,87,90,93,95,97,99,103,106,108,111,113,115,118,121,123,125,127,129,131,133,135,137,139,142,144],{"measure":80,"timeFrame":81},"Maximum observed concentration (Cmax)","Up to Day 26 from last dose",{"measure":83,"timeFrame":81},"Time of maximum observed concentration (Tmax)",{"measure":85,"description":86,"timeFrame":81},"Area under the concentration-time curve from Time Zero to Time of Last Quantifiable Concentration (AUC(0-T))","Arm A, Arm B, and Arm C",{"measure":88,"description":89,"timeFrame":81},"AUC from Time Zero Extrapolated to Infinite Time (AUC(INF))","Arm A and Arm C",{"measure":91,"description":45,"timeFrame":92},"AUC from Time Zero to 24 Hours (AUC(0-24))","Up to Day 9 from last dose",{"measure":94,"description":86,"timeFrame":81},"Elimination Half-Life (T-HALF)",{"measure":96,"description":86,"timeFrame":81},"Apparent Total Body Clearance from Plasma (CLT\u002FF)",{"measure":98,"description":86,"timeFrame":81},"Apparent Volume of Distribution (Vz\u002FF)",{"measure":100,"description":101,"timeFrame":102},"AUC in 1 dosing interval (AUC (TAU))","Arm B, D","Up to Day 22 from last dose",{"measure":104,"description":46,"timeFrame":105},"Cerebrospinal fluid (CSF) concentrations","Up to Day 13",{"measure":107,"description":46,"timeFrame":105},"Ratio of total and unbound CSF to plasma concentration",{"measure":109,"description":110,"timeFrame":81},"Geometric mean ratio of Cmax","Arm C, D",{"measure":112,"description":110,"timeFrame":81},"Geometric mean ratio of AUC(0-T)",{"measure":114,"description":110,"timeFrame":81},"Geometric mean ratio of AUC(INF)",{"measure":116,"description":48,"timeFrame":117},"Cmax of dabigatran in plasma","Up to Day 18 from last dose",{"measure":119,"description":48,"timeFrame":120},"Cmax of rosuvastatin in plasma","Up to Day 20 from last dose",{"measure":122,"description":48,"timeFrame":117},"AUC(0-T) of dabigatran in plasma",{"measure":124,"description":48,"timeFrame":120},"AUC(0-T) of rosuvastatin in plasma",{"measure":126,"description":48,"timeFrame":117},"AUC(INF) of dabigatran in plasma",{"measure":128,"description":48,"timeFrame":120},"AUC(INF) of rosuvastatin in plasma",{"measure":130,"description":48,"timeFrame":117},"Tmax of dabigatran in plasma",{"measure":132,"description":48,"timeFrame":120},"Tmax of rosuvastatin in plasma",{"measure":134,"timeFrame":81},"T-HALF of dabigatran in plasma",{"measure":136,"description":48,"timeFrame":120},"T-HALF of rosuvastatin in plasma",{"measure":138,"description":48,"timeFrame":117},"CLT\u002FF of dabigatran in plasma",{"measure":140,"timeFrame":141},"CLT\u002FF of rosuvastatin in plasma","Up to Day 27 from last dose",{"measure":143,"description":48,"timeFrame":117},"Vz\u002FF of dabigatran in plasma",{"measure":145,"description":48,"timeFrame":120},"Vz\u002FF of rosuvastatin in plasma","ALL","18 Years","55 Years",true,{"inclusion":151,"exclusion":155,"raw_text":160},[152,153,154],"Participants must have a body mass index (BMI) of 18 to 32.44 kg\u002Fm2, inclusive, and total body weight ≥ 50 kg.","Female (as assigned at birth) participants who are not of childbearing potential must have documented proof of reproductive status.","A male (as assigned at birth) who is sexually active with IOCBP must agree to follow instructions for method(s) of contraception as described and included in the ICF.",[156,157,158,159],"Participants must not have presence or history of any clinically relevant abnormality, condition, or disease of renal, hepatic, hematologic, GI, endocrine, pulmonary, neurologic, or immunologic (including history of angioedema or hypersensitivity reactions to medication).","Participants must not have current or recent (within 3 months of study intervention administration) clinically significant GI disease.","Participants must not have any major surgery within 3 months of study intervention administration.","Participants must not have Any surgical or medical intervention that could possibly affect ADME of study intervention (eg, bariatric surgery, GI surgery).","Inclusion Criteria:\n\n* Participants must have a body mass index (BMI) of 18 to 32.44 kg\u002Fm2, inclusive, and total body weight ≥ 50 kg.\n* Female (as assigned at birth) participants who are not of childbearing potential must have documented proof of reproductive status.\n* A male (as assigned at birth) who is sexually active with IOCBP must agree to follow instructions for method(s) of contraception as described and included in the ICF.\n\nExclusion Criteria:\n\n* Participants must not have presence or history of any clinically relevant abnormality, condition, or disease of renal, hepatic, hematologic, GI, endocrine, pulmonary, neurologic, or immunologic (including history of angioedema or hypersensitivity reactions to medication).\n* Participants must not have current or recent (within 3 months of study intervention administration) clinically significant GI disease.\n* Participants must not have any major surgery within 3 months of study intervention administration.\n* Participants must not have Any surgical or medical intervention that could possibly affect ADME of study intervention (eg, bariatric surgery, GI surgery).\n* Other protocol defined inclusion\u002Fexclusion criteria applies.",[162],"ADULT",[164],{"facility":165,"status":8,"city":166,"state":167,"zip":168,"country":169,"contacts":170,"geoPoint":174},"Celerion Coorporate Office Nebraska","Lincoln","Nebraska","68502","United States",[171],{"name":172,"role":173},"Allen Hunt, Site 0001","CONTACT",{"lat":175,"lon":176},40.8,-96.66696,[178,182],{"name":179,"role":173,"phone":180,"email":181},"BMS Clinical Trials Contact Center www.BMSClinicalTrials.com","855-907-3286","Clinical.Trials@bms.com",{"name":183,"role":173},"First line of the email MUST contain NCT # and Site #.",[185],{"name":13,"affiliation":13,"role":186},"STUDY_DIRECTOR",[],[189,192],{"label":190,"url":191},"BMS Clinical Trial Information","https:\u002F\u002Fwww.bms.com\u002Fresearchers-and-partners\u002Fclinical-trials-and-research.html",{"label":193,"url":194},"BMS Clinical Trial Patient Recruiting","https:\u002F\u002Fwww.bmsclinicaltrials.com\u002Fus\u002Fen\u002Fclinical-trials\u002FNCT07629999.html",{"nct_id":4,"conditions":196,"biomarkers":197},[19],[],{"nct_id":4,"found":149,"summary":199,"prompt_version":209},{"design":200,"status":201,"heading":202,"summary":203,"follow_up":204,"word_count":205,"commitments":206,"compensation":207,"drugs_mentioned":208},"This interventional study plans to enroll 136 healthy participants. It will involve giving participants BMS-986533, Famotidine, Placebo, Dabigatran Etexilate, or Rosuvastatin.","completed","Study of BMS-986533 in Healthy Volunteers","This study is looking for healthy volunteers aged 18 to 55 years old to test a drug called BMS-986533. The main goals are to understand how safe BMS-986533 is and how your body handles it (pharmacokinetics) when given in single or multiple doses. Researchers will also see how food and stomach acid (pH) affect the drug, and if it interacts with other common medications like Famotidine, Dabigatran Etexilate, or Rosuvastatin. Success for this study means understanding the safety of BMS-986533 and how it works in the body. The study plans to enroll 136 participants, but its current recruitment status is unclear.","Participants will be monitored for adverse events for up to 47 days and for vital sign abnormalities for up to 27 days.",101,"Not specified in the trial record.","Not stated in the trial record.",[22,50,56,28],"v2"]