[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07248839":3,"trial-entities:NCT07248839":136,"trial-summary:NCT07248839":140},{"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":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":40,"secondary_outcomes":48,"sex":61,"minimum_age":62,"maximum_age":63,"healthy_volunteers":64,"eligibility_criteria":65,"std_ages":76,"locations":79,"central_contacts":118,"overall_officials":125,"references":128,"see_also_links":129},"NCT07248839","CV029-1017","A Study to Assess the Drug Levels and Safety of BMS-986435 in Participants With Normal Hepatic Function and Participants With Different Degrees of Hepatic Impairment","A Phase 1, Multi-center, Open-label, Single-dose Study to Assess the Pharmacokinetics and Safety of BMS-986435 in Participants With Normal Hepatic Function and Participants With Mild and Moderate Hepatic Impairment","RECRUITING","2026-08-05","2026-06","2026-06-12","2025-12-15","Bristol-Myers Squibb","INDUSTRY",false,"The purpose of this study is to determine the pharmacokinetic and safety of BMS-986435 in participants with normal hepatic function and participants with different degrees of hepatic impairment",null,[19,20],"Healthy Volunteers","Hepatic Impairment",[],"INTERVENTIONAL","TREATMENT",[25],"PHASE1",{"count":27,"type":28},24,"ESTIMATED",[30],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":38},"DRUG","BMS-986435","Specified dose on specified days",[35,36,37],"Arm A","Arm B","Arm C",[39],"MYK-224",[41,44,46],{"measure":42,"timeFrame":43},"Maximum observed concentration (Cmax)","Up to Day 45",{"measure":45,"timeFrame":43},"Area under the concentration-time curve from time zero to time of last quantifiable concentration AUC(0-T)",{"measure":47,"timeFrame":43},"Area under the concentration-time curve from time zero extrapolated to infinite time AUC(INF)",[49,51,53,55,57,59],{"measure":50,"timeFrame":43},"Number of participants with adverse events (AEs)",{"measure":52,"timeFrame":43},"Number of participants with serious adverse events (SAEs)",{"measure":54,"timeFrame":43},"Time of maximum observed concentration (Tmax)",{"measure":56,"timeFrame":43},"Half-life (T-HALF)",{"measure":58,"timeFrame":43},"Apparent total body clearance (CLT\u002FF)",{"measure":60,"timeFrame":43},"Apparent volume of distribution at terminal phase (Vz\u002FF)","ALL","18 Years","75 Years",true,{"inclusion":66,"exclusion":70,"raw_text":75},[67,68,69],"Participant must have documented LVEF ≥ 60% (2D biplane Simpson's Method) and absence of cardiac abnormality.","Participant must have body weight of \\> 50 kg and BMI of 18.0 kg\u002Fm2 through 40 kg\u002Fm2, inclusive, at screening.","Participants must have adequate renal function at screening as evidenced by an eGFR \\> 60 mL\u002Fmin\u002F1.73 m2 for participants calculated with the CKD-EPI Creatinine Equation (2021).",[71,72,73,74],"Participants must not have history of or current uncontrolled or unstable clinically significant disorder, condition, or disease that, in the opinion of the investigator and CRO MM, would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion.","Participants must not have head injury in the last 2 years, intracranial tumor, or aneurysm.","Participants must not have history of malignancy of any type, except in situ cervical cancer \\>5 years prior to the screening visit or surgically excised non-melanomatous skin cancer \\>2 years prior to the screening visit.","Participants must not have History of heart disease (including coronary artery disease, heart failure\u002FLV systolic dysfunction, cardiomyopathy, or clinically significant structural disease).","Inclusion Criteria:\n\n* Participant must have documented LVEF ≥ 60% (2D biplane Simpson's Method) and absence of cardiac abnormality.\n* Participant must have body weight of \\> 50 kg and BMI of 18.0 kg\u002Fm2 through 40 kg\u002Fm2, inclusive, at screening.\n* Participants must have adequate renal function at screening as evidenced by an eGFR \\> 60 mL\u002Fmin\u002F1.73 m2 for participants calculated with the CKD-EPI Creatinine Equation (2021).\n\nExclusion Criteria:\n\n* Participants must not have history of or current uncontrolled or unstable clinically significant disorder, condition, or disease that, in the opinion of the investigator and CRO MM, would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion.\n* Participants must not have head injury in the last 2 years, intracranial tumor, or aneurysm.\n* Participants must not have history of malignancy of any type, except in situ cervical cancer \\>5 years prior to the screening visit or surgically excised non-melanomatous skin cancer \\>2 years prior to the screening visit.\n* Participants must not have History of heart disease (including coronary artery disease, heart failure\u002FLV systolic dysfunction, cardiomyopathy, or clinically significant structural disease).\n* Other protocol defined inclusion\u002Fexclusion criteria applies.",[77,78],"ADULT","OLDER_ADULT",[80,94,106],{"facility":81,"status":8,"city":82,"state":83,"zip":84,"country":85,"contacts":86,"geoPoint":91},"Arizona Clinical Trials","Chandler","Arizona","85225","United States",[87],{"name":88,"role":89,"phone":90},"Anita Kohli, Site 0003","CONTACT","434-825-0921",{"lat":92,"lon":93},33.30616,-111.84125,{"facility":95,"status":8,"city":96,"state":97,"zip":98,"country":85,"contacts":99,"geoPoint":103},"Panax Clinical Research","Miami Lakes","Florida","33014",[100],{"name":101,"role":89,"phone":102},"Robert Perry, Site 0002","305-698-4500",{"lat":104,"lon":105},25.90871,-80.30866,{"facility":107,"status":8,"city":108,"state":109,"zip":110,"country":85,"contacts":111,"geoPoint":115},"Texas Liver Institute","San Antonio","Texas","78215",[112],{"name":113,"role":89,"phone":114},"Eric Lawitz, Site 0001","210-253-3426",{"lat":116,"lon":117},29.42412,-98.49363,[119,123],{"name":120,"role":89,"phone":121,"email":122},"BMS Clinical Trials Contact Center www.BMSClinicalTrials.com","855-907-3286","Clinical.Trials@bms.com",{"name":124,"role":89},"First line of the email MUST contain the NCT# and Site #.",[126],{"name":13,"affiliation":13,"role":127},"STUDY_DIRECTOR",[],[130,133],{"label":131,"url":132},"BMS Clinical Trial Information","https:\u002F\u002Fwww.bms.com\u002Fresearchers-and-partners\u002Fclinical-trials-and-research.html",{"label":134,"url":135},"BMS Clinical Trial Patient Recruiting","https:\u002F\u002Fwww.BMSClinicalTrials.com",{"nct_id":4,"conditions":137,"biomarkers":139},[19,138],"Liver Failure",[],{"nct_id":4,"found":15,"summary":17,"prompt_version":17}]