[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07283263":3,"trial-entities:NCT07283263":155,"trial-summary:NCT07283263":158},{"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":29,"primary_purpose":30,"phases":31,"enrollment_info":33,"interventions":36,"primary_outcomes":58,"secondary_outcomes":67,"sex":104,"minimum_age":105,"maximum_age":106,"healthy_volunteers":107,"eligibility_criteria":108,"std_ages":119,"locations":122,"central_contacts":137,"overall_officials":144,"references":147,"see_also_links":148},"NCT07283263","CN014-0001","A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986521 in Healthy Participants.","A Phase 1, Randomized, Placebo-Controlled, Double-Blind, First-in-Human Study Evaluating Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of Orally Administered BMS-986521 in Healthy Adult Participants","RECRUITING","2026-11-17","2026-01","2026-01-07","2025-12-23","Bristol-Myers Squibb","INDUSTRY",false,"The purpose of this study is to evaluate the safety, tolerability, and drug levels of BMS-986521 following single and multiple ascending doses of BMS-986521 in healthy adult participants, and to evaluate potential food effects on BMS-986521 exposure.",null,[19],"Healthy Volunteers",[19,21,22,23,24,25,26,27,28],"Pharmacokinetics","BMS-986521","Placebo","Drug-food Interaction","Single Ascending Dose (SAD)","Multiple Ascending Dose (MAD)","Elderly","Relative Bioavailability","INTERVENTIONAL","TREATMENT",[32],"PHASE1",{"count":34,"type":35},106,"ESTIMATED",[37,54],{"type":38,"name":39,"description":40,"armGroupLabels":41},"DRUG","BMS-985521","Specified dose on specified days.",[42,43,44,45,46,47,48,49,50,51,52,53],"Part A Cohort 1","Part A Cohort 2","Part A Cohort 3","Part A Cohort 4","Part A Cohort 5","Part A Cohort 6","Part B Cohort 10","Part B Cohort 11","Part B Cohort 7","Part B Cohort 8","Part B Cohort 9","Part C",{"type":55,"name":23,"description":56,"armGroupLabels":57},"OTHER","Specified dose on specified days",[42,43,44,45,46,47,48,49,50,51,52],[59,62,64],{"measure":60,"timeFrame":61},"Number of participants with treatment-emergent adverse events (AEs)","Up to approximately Day 40",{"measure":63,"timeFrame":61},"Number of participants with treatment-emergent serious adverse events (SAEs)",{"measure":65,"timeFrame":66},"Number of participants with Treatment-emergent suicidal ideation and behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)","Up to approximately Day 14",[68,70,72,74,76,78,80,82,84,86,88,90,94,96,98,100,102],{"measure":69,"timeFrame":66},"Maximum Concentration (Cmax) of BMS-986521 in Plasma",{"measure":71,"timeFrame":66},"Time to Cmax (Tmax) of BMS-986521 in Plasma",{"measure":73,"timeFrame":66},"Area Under the Concentration-Time Curve from Time Zero to the Last Measured Time Point (AUC(0-T)) of BMS-986521 in Plasma",{"measure":75,"timeFrame":66},"Area Under the Concentration-Time Curve from Time Zero to 24 Hours (AUC(0-24)) of BMS-986521 in Plasma",{"measure":77,"timeFrame":66},"Area Under the Concentration-Time Curve from Time Zero Extrapolated to Infinity (AUC(INF)) of BMS-986521 in Plasma",{"measure":79,"timeFrame":66},"Concentration Over a Dosing Interval (tau) (AUC(TAU)) of BMS-986521 in Plasma",{"measure":81,"timeFrame":66},"Elimination Half-Life (T-HALF) of BMS-986521 in Plasma",{"measure":83,"timeFrame":66},"Apparent Clearance of BMS-986521 from Plasma after Dosing (CLT\u002FF)",{"measure":85,"timeFrame":66},"Apparent Volume of Distribution in Plasma after Dosing (Vz\u002FF) of BMS-986521",{"measure":87,"timeFrame":66},"Accumulation Index Based on Maximum Concentration (Cmax) in Plasma after Multiple Dosing (AI_Cmax) of BMS-986521",{"measure":89,"timeFrame":66},"Accumulation Index Based on Area Under the Curve (AUC) in Plasma After Multiple Dosing (AI_AUC) of BMS-986521",{"measure":91,"description":92,"timeFrame":93},"Geometric Mean Cmax BMS-986521 under fed and fasted conditions","Cohort 3","Up to approximately Day 11",{"measure":95,"description":92,"timeFrame":93},"Geometric Mean AUC(0-T) BMS-986521 under fed and fasted conditions",{"measure":97,"description":92,"timeFrame":93},"Geometric Mean AUC(INF) BMS-986521 under fed and fasted conditions",{"measure":99,"description":53,"timeFrame":93},"Geometric mean ratios of Cmax for BMS-986521 oral tablet vs solution",{"measure":101,"description":53,"timeFrame":93},"Geometric mean ratios of AUC(0-T) for BMS-986521 oral tablet vs solution",{"measure":103,"description":53,"timeFrame":93},"Geometric mean ratios of AUC(INF) for BMS-986521 oral tablet vs solution","ALL","18 Years","80 Years",true,{"inclusion":109,"exclusion":113,"raw_text":118},[110,111,112],"Participants must be healthy males and females (assigned at birth) who are not of childbearing potential, with no clinically significant abnormalities in medical history, physical exam, ECG, or lab tests.","Participants must have a body mass index (BMI) between 18 and 32 kg\u002Fm² (inclusive) and body weight of at least 50 kg.","For Part B\u002FCohort 11 only: participants with stable cardiovascular conditions may be included if deemed suitable by the investigator.",[114,115,116,117],"Participants must not have any significant medical condition or history (renal, hepatic, hematologic, GI, endocrine, pulmonary, neurologic, or immunologic) that may affect drug absorption, distribution, metabolism, or excretion (ADME), or pose a risk to the participant.","Participants must not have a history of rhabdomyolysis, cancer (except certain cured skin or cervical cancers), hematologic malignancy, or myelodysplastic syndrome.","Participants must not have recent or current significant GI disease, major surgery, or medical interventions affecting ADME (except appendectomy or cholecystectomy).","Participants must not have had a blood transfusion within 4 weeks or have an inability to tolerate oral medication or venous access.","Inclusion Criteria:\n\n* Participants must be healthy males and females (assigned at birth) who are not of childbearing potential, with no clinically significant abnormalities in medical history, physical exam, ECG, or lab tests.\n* Participants must have a body mass index (BMI) between 18 and 32 kg\u002Fm² (inclusive) and body weight of at least 50 kg.\n* For Part B\u002FCohort 11 only: participants with stable cardiovascular conditions may be included if deemed suitable by the investigator.\n\nExclusion Criteria:\n\n* Participants must not have any significant medical condition or history (renal, hepatic, hematologic, GI, endocrine, pulmonary, neurologic, or immunologic) that may affect drug absorption, distribution, metabolism, or excretion (ADME), or pose a risk to the participant.\n* Participants must not have a history of rhabdomyolysis, cancer (except certain cured skin or cervical cancers), hematologic malignancy, or myelodysplastic syndrome.\n* Participants must not have recent or current significant GI disease, major surgery, or medical interventions affecting ADME (except appendectomy or cholecystectomy).\n* Participants must not have had a blood transfusion within 4 weeks or have an inability to tolerate oral medication or venous access.\n* Other protocol defined inclusion\u002Fexclusion criteria apply.",[120,121],"ADULT","OLDER_ADULT",[123],{"facility":124,"status":8,"city":125,"state":126,"zip":127,"country":128,"contacts":129,"geoPoint":134},"CenExel ACT (Formerly Anaheim Clinical Trials; LLC)","Anaheim","California","92801","United States",[130],{"name":131,"role":132,"phone":133},"Peter Winkle, Site 0001","CONTACT","949-295-7809",{"lat":135,"lon":136},33.83529,-117.9145,[138,142],{"name":139,"role":132,"phone":140,"email":141},"BMS Clinical Trials Contact Center www.BMSClinicalTrials.com","855-907-3286","Clinical.Trials@bms.com",{"name":143,"role":132},"First line of the email MUST contain the NCT# and Site #.",[145],{"name":13,"affiliation":13,"role":146},"STUDY_DIRECTOR",[],[149,152],{"label":150,"url":151},"BMS Clinical Trial Information","https:\u002F\u002Fwww.bms.com\u002Fresearchers-and-partners\u002Fclinical-trials-and-research.html",{"label":153,"url":154},"BMS Clinical Trial Patient Recruiting","https:\u002F\u002Fwww.bmsclinicaltrials.com\u002Fus\u002Fen\u002Fclinical-trials\u002FNCT07283263.html",{"nct_id":4,"conditions":156,"biomarkers":157},[19],[],{"nct_id":4,"found":107,"summary":159,"prompt_version":169},{"design":160,"status":161,"heading":162,"summary":163,"follow_up":164,"word_count":165,"commitments":166,"compensation":167,"drugs_mentioned":168},"This is an interventional study involving 106 healthy participants. Participants will receive either BMS-986521 or a placebo.","completed","A Study of BMS-986521 in Healthy Volunteers","This study is looking for healthy adults to help evaluate a new drug called BMS-986521. Researchers want to understand how safe BMS-986521 is, how well your body tolerates it, and how much of the drug stays in your system. You might receive BMS-986521 or a placebo (an inactive substance, like a sugar pill). The study will also look at how food might affect the drug. To join, you must be between 18 and 80 years old, healthy, and meet specific weight and health criteria. The main goals are to track any side effects and serious side effects, and to monitor for any thoughts of self-harm, for up to about 40 days.","Participants will be monitored for side effects for up to approximately 40 days after treatment, and for suicidal thoughts and behavior for up to about 14 days.",111,"Not specified in the trial record.","Not stated in the trial record.",[23],"v2"]