[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658646":3},{"organization":4,"outcomesModule":7,"designInfo":43,"detailedDescription":49,"studyPopulation":11,"armGroups":50,"interventions":61,"overallOfficials":70,"centralContacts":74,"locations":11,"responsibleParty":79,"collaborators":11,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":11,"eligibilityCriteria":87,"healthyVolunteers":88,"sex":89,"minAge":90,"maxAge":91,"enrollmentInfo":92,"targetDuration":11,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":102,"overallStatus":106,"whyStopped":11,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":11},{"fullName":5,"class":6},"BeOne Medicines","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":28,"otherOutcomes":11},[9,13,15,17,19,21,23,25],{"measure":10,"description":11,"timeFrame":12},"Area under the plasma concentration-time curve (AUC) from time 0 to the last quantifiable concentration (AUC0-t) of Sonrotoclax",null,"Days 1-3",{"measure":14,"description":11,"timeFrame":12},"AUC from time 0 extrapolated to infinity (AUC0-inf) of Sonrotoclax",{"measure":16,"description":11,"timeFrame":12},"Maximum observed plasma concentration (Cmax) of Sonrotoclax",{"measure":18,"description":11,"timeFrame":12},"Time to reach maximum observed plasma concentration (Tmax) of Sonrotoclax",{"measure":20,"description":11,"timeFrame":12},"Apparent terminal elimination half-life (t1\u002F2) of Sonrotoclax",{"measure":22,"description":11,"timeFrame":12},"Apparent oral clearance (CL\u002FF) of Sonrotoclax",{"measure":24,"description":11,"timeFrame":12},"Apparent volume of distribution (Vz\u002FF) of Sonrotoclax",{"measure":26,"description":11,"timeFrame":27},"Fraction unbound (Fu) of Sonrotoclax","Day 1",[29,33,37,40],{"measure":30,"description":31,"timeFrame":32},"Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)","Number of participants with TEAEs and SAEs, including adverse events with onset or increase in severity level on or after single dose administration.","Approximately 10 days",{"measure":34,"description":35,"timeFrame":36},"Number of Participants with Laboratory Abnormalities","Number of participants with laboratory abnormalities, based on hematology, clinical chemistry, and urinalysis test results. Clinical laboratory values will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 for selected laboratory analytes.","Approximately 3 days",{"measure":38,"description":39,"timeFrame":36},"Number of Participants with Clinically Significant Vital Signs Measurements","Vital signs include pulse rate, body temperature, and blood pressure.",{"measure":41,"description":42,"timeFrame":36},"Number of Participants with Clinically Significant Physical Examination Findings","Number of participants with clinically significant physical examination findings, including new or worsened clinically significant abnormalities.",{"allocation":44,"interventionModel":45,"interventionModelDescription":11,"primaryPurpose":46,"observationalModel":11,"timePerspective":11,"maskingInfo":47},"NON_RANDOMIZED","PARALLEL","OTHER",{"masking":48,"maskingDescription":11,"whoMasked":11},"NONE","Sonrotoclax is a drug which blocks a protein called B-cell lymphoma-2 (Bcl-2). Bcl-2 helps certain blood cancer cells live and grow. By blocking Bcl-2, sonrotoclax may slow or stop cancer cell growth and help them die.\n\nThe purpose of this study is to look at the safety and blood levels of sonrotoclax in adults with serious liver problems. Results from this study will help researchers understand if dose changes are needed for adults with liver problems.\n\nParticipants will take one dose of sonrotoclax by mouth with food and remain in the clinic for about 3 days of monitoring. This study is an open-label study, meaning that both participants and study doctors will know what study drug\u002Ftreatment is given.\n\nThe study will enroll approximately 12 adults in the United States (6 adults with serious liver problems and 6 adults with normal liver function).\n\nThe overall time to participate in this study is approximately 4 weeks. Participants will make regular visits to the clinic for health checks, blood tests, sonrotoclax administration and monitoring, and follow-up.",[51,57],{"label":52,"type":53,"description":54,"interventionNames":55},"Group 1: Severe Hepatic Impairment","EXPERIMENTAL","Participants with severe hepatic impairment will receive a single dose of sonrotoclax on Day 1.",[56],"Drug: Sonrotoclax",{"label":58,"type":53,"description":59,"interventionNames":60},"Group 2: Normal Hepatic Function","Participants with normal hepatic function will receive a single dose of sonrotoclax on Day 1.",[56],[62],{"type":63,"name":64,"description":65,"armGroupLabels":66,"otherNames":67},"DRUG","Sonrotoclax","Single dose administered orally.",[52,58],[68,69],"BGB-11417","BEQALZI",[71],{"name":72,"affiliation":5,"role":73},"Study Director","STUDY_DIRECTOR",[75],{"name":72,"role":76,"phone":77,"phoneExt":11,"email":78},"CONTACT","1.877.828.5568","clinicaltrials@beonemed.com",{"type":80,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100658646","phase-1-a-study-to-investigate-the-safety-tolerability-and-pharmacokinetics-of-sonrotoclax-in-participants-with-severe-hepatic-impairment-100658646",false,"NCT07855991","A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Sonrotoclax in Participants With Severe Hepatic Impairment","A Phase 1, Open-label, Single-dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Sonrotoclax in Participants With Severe Hepatic Impairment","General Inclusion Criteria:\n\n* Body Mass Index (BMI) between 18.0 and 42.0 kg\u002Fm\\^2, inclusive\n* Generally stable health (except for hepatic impairment in hepatically impaired participants) as determined by the Investigator based on medical evaluation at Screening and Check-in, with no clinically significant findings that would interfere with study participation\n* Female participants of non-childbearing potential who meet any of the following criteria: surgically sterile or postmenopausal\n* Male participants are eligible if vasectomized or if they agree to the use of barrier contraception with other highly effective methods if sexually active with women of childbearing potential, during study treatment and for at least 7 days after the dose of study drug\n\nInclusion Criteria for Severe Hepatic Impairment Group:\n\n* Severe hepatic dysfunction per National Cancer Institute-Organ Dysfunction Working Group (NCI-ODWG) criteria (serum total bilirubin \\> 3 × upper limit of normal \\[ULN\\], any aspartate aminotransferase \\[AST\\])\n* Clinically stable hepatic disease, in the opinion of the investigator, with no clinically significant worsening of hepatic function within 4 weeks prior to dosing\n\nInclusion Criteria for Normal Hepatic Function Group:\n\n* Normal hepatic function, including total bilirubin ≤ ULN and AST ≤ ULN\n* Absolute B-cell count of \\> 150 cells\u002FμL\n\nGeneral Exclusion Criteria:\n\n* Any clinically significant disease or condition that, in the opinion of the Investigator, would interfere with study participation, safety, or evaluation of study results\n* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, as determined by the investigator\n* Evidence of any infections (bacterial, viral, fungal, parasitic) within 2-4 weeks prior to the first dose of study drug, as determined by the investigator (or designee)\n* Positive urine drug screen or alcohol urine\u002Fbreath test\u002Fblood results at screening or check-in\n* History of alcoholism or drug\u002Fchemical abuse within the last 2 years\n\nExclusion Criteria for Severe Hepatic Impairment Group:\n\n* Acute hepatic disease or rapidly deteriorating hepatic function\n* History of liver transplantation\n* Previously diagnosed hepatocellular carcinoma, or history of cholestatic liver disease or biliary sepsis within the past 2 years\n\nExclusion Criteria for Normal Hepatic Function Group:\n\n* Any known or suspected hepatic disease\n* Clinically significant abnormalities in liver function tests at Screening\n* Require ongoing use of prescription or nonprescription medications, including herbal supplements (unless the medication is not expected to interfere with the pharmacokinetics, safety, or tolerability of the study drug)\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",true,"ALL","18 Years","75 Years",{"count":93,"type":94},12,"ESTIMATED","INTERVENTIONAL",[97],"PHASE1","The goal of this study is to understand how the body processes sonrotoclax in adults with serious liver problems compared to adults with normal liver function.",[100,101],"Hepatic Impairment","Healthy Adult Participants",[103,104,105],"sonrotoclax","Pharmacokinetics","BCL2i","NOT_YET_RECRUITING","2026-09-29",{"date":109,"type":110},"2026-10-02","ACTUAL",{"date":112,"type":94},"2026-10-15",{"date":114,"type":94},"2027-02-08",{"name":5,"class":6}]