[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07723118":3,"trial-entities:NCT07723118":115,"trial-summary:NCT07723118":119},{"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":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":39,"secondary_outcomes":55,"sex":67,"minimum_age":68,"maximum_age":69,"healthy_volunteers":70,"eligibility_criteria":71,"std_ages":80,"locations":82,"central_contacts":96,"overall_officials":103,"references":107,"see_also_links":108},"NCT07723118","CA239-0028","A Study to Assess the Pharmacokinetics, Safety and Tolerability of Single-dose Adagrasib (BMS-986503) in Healthy Participants of Japanese Descent","A Phase 1, Single-dose, Open-label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Adagrasib (BMS-986503) in Healthy Participants of Japanese Descent","NOT_YET_RECRUITING","2026-09-12","2026-07","2026-07-23","2026-08-05","Mirati Therapeutics Inc.","INDUSTRY",false,"The aim of this study is to assess the pharmacokinetics, safety and tolerability of single-dose Adagrasib (BMS-986503) in healthy participants of Japanese descent",null,[19],"Healthy Participants",[21,22],"Japanese Descent","Phase 1","INTERVENTIONAL","TREATMENT",[26],"PHASE1",{"count":28,"type":29},10,"ESTIMATED",[31],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"DRUG","Adagrasib","Specified dose on specified days",[33],[37,38],"BMS-986503","MRTX849",[40,43,45,47,49,51,53],{"measure":41,"timeFrame":42},"Maximum Observed Plasma Concentration (Cmax)","Up to Day 7",{"measure":44,"timeFrame":42},"Time of Maximum Observed Plasma Concentration",{"measure":46,"timeFrame":42},"Area Under the Plasma Concentration-time Curve from Time Zero Extrapolated to Infinite Time [AUC(INF)]",{"measure":48,"timeFrame":42},"Area Under the Plasma Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration [AUC(0-T)]",{"measure":50,"timeFrame":42},"Apparent Terminal Phase Half-life (T-HALF)",{"measure":52,"timeFrame":42},"Apparent Total Body Clearance (CLT\u002FF)",{"measure":54,"timeFrame":42},"Volume of Distribution of Terminal Phase (Vz\u002FF)",[56,59,61,63,65],{"measure":57,"timeFrame":58},"Number of Participants with Treatment Emergent Adverse Events (AEs)","Up to Day 13",{"measure":60,"timeFrame":42},"Number of Participants with Clinical Laboratory Test Abnormalities",{"measure":62,"timeFrame":42},"Number of Participants with Vital Sign Abnormalities",{"measure":64,"timeFrame":42},"Number of Participants with Physical Examination (PE) Abnormalities",{"measure":66,"timeFrame":42},"Number of Participants with 12-Lead Electrocardiogram (ECG) Abnormalities","ALL","18 Years","60 Years",true,{"inclusion":72,"exclusion":77,"raw_text":79},[73,74,75,76],"Participants must be of Japanese descent (both biological parents of the participant are ethnically Japanese).","Participants must be healthy adult without clinically significant deviation from normal in medical history, PE, 12-lead ECG, vital sign measurements, and clinical laboratory assessments as determined by the investigator.","Participants must have Body mass index of 18.0 kg\u002Fm2 to 32.0 kg\u002Fm2.","Participants must have Total body weight ≥ 50 kg.",[78],"Participants must not have significant history or clinical manifestation of any metabolic, allergic, dermatological, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator.","Inclusion Criteria:\n\n* Participants must be of Japanese descent (both biological parents of the participant are ethnically Japanese).\n* Participants must be healthy adult without clinically significant deviation from normal in medical history, PE, 12-lead ECG, vital sign measurements, and clinical laboratory assessments as determined by the investigator.\n* Participants must have Body mass index of 18.0 kg\u002Fm2 to 32.0 kg\u002Fm2.\n* Participants must have Total body weight ≥ 50 kg.\n\nExclusion Criteria:\n\n* Participants must not have significant history or clinical manifestation of any metabolic, allergic, dermatological, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator.\n* Other protocol defined Inclusion\u002FExclusion criteria apply.",[81],"ADULT",[83],{"facility":84,"city":85,"state":86,"zip":87,"country":88,"contacts":89,"geoPoint":93},"Local Institution - 0001","Anaheim","California","92801","United States",[90],{"name":91,"role":92},"Site 0001","CONTACT",{"lat":94,"lon":95},33.83529,-117.9145,[97,101],{"name":98,"role":92,"phone":99,"email":100},"BMS Clinical Trials Contact Center www.BMSClinicalTrials.com","855-907-3286","Clinical.Trials@bms.com",{"name":102,"role":92},"First line of the email MUST contain NCT # and Site #.",[104],{"name":105,"affiliation":105,"role":106},"Bristol-Myers Squibb","STUDY_DIRECTOR",[],[109,112],{"label":110,"url":111},"BMS Clinical Trial Information","https:\u002F\u002Fwww.bms.com\u002Fresearchers-and-partners\u002Fclinical-trials-and-research.html",{"label":113,"url":114},"BMS Clinical Trial Patient Recruiting","https:\u002F\u002Fwww.BMSClinicalTrials.com",{"nct_id":4,"conditions":116,"biomarkers":118},[117],"Healthy Volunteers",[],{"nct_id":4,"found":70,"summary":120,"prompt_version":130},{"design":121,"status":122,"heading":123,"summary":124,"follow_up":125,"word_count":126,"commitments":127,"compensation":128,"drugs_mentioned":129},"This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 10 healthy participants.","completed","Study of Adagrasib in Healthy Japanese Participants","This study is looking at a single dose of Adagrasib (BMS-986503) in healthy volunteers of Japanese descent. Researchers want to understand how the body processes the drug (pharmacokinetics), and if it is safe and well-tolerated. They will measure the highest amount of the drug in your blood (Maximum Observed Plasma Concentration or Cmax) and how long it takes to reach that level, as well as the total amount of drug in your system over time (Area Under the Plasma Concentration-time Curve). To join, you must be a healthy adult of Japanese descent, between 18 and 60 years old. The study aims to enroll 10 participants, but its current recruitment status is unclear.","The primary endpoints for measuring drug levels are up to Day 7 after receiving the dose.",112,"Not specified in the trial record.","Not stated in the trial record.",[33],"v2"]