[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658732":3},{"organization":4,"outcomesModule":7,"designInfo":43,"detailedDescription":49,"studyPopulation":11,"armGroups":50,"interventions":65,"overallOfficials":73,"centralContacts":77,"locations":11,"responsibleParty":82,"collaborators":11,"id":84,"slug":85,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":11,"eligibilityCriteria":90,"healthyVolunteers":91,"sex":92,"minAge":93,"maxAge":94,"enrollmentInfo":95,"targetDuration":11,"studyType":98,"phases":99,"briefSummary":101,"conditions":102,"keywords":105,"overallStatus":108,"whyStopped":11,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"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-tlast) of Tacabrutideg",null,"Days 1-20",{"measure":14,"description":11,"timeFrame":12},"AUC from time 0 extrapolated to infinity (AUC0-∞) of Tacabrutideg",{"measure":16,"description":11,"timeFrame":12},"Maximum observed plasma concentration (Cmax) of Tacabrutideg",{"measure":18,"description":11,"timeFrame":12},"Time to reach maximum observed plasma concentration (Tmax) of Tacabrutideg",{"measure":20,"description":11,"timeFrame":12},"Apparent terminal elimination half-life (t½) of Tacabrutideg",{"measure":22,"description":11,"timeFrame":12},"Apparent oral clearance (CL\u002FF) of Tacabrutideg",{"measure":24,"description":11,"timeFrame":12},"Apparent volume of distribution (Vz\u002FF) of Tacabrutideg",{"measure":26,"description":11,"timeFrame":27},"Fraction unbound (Fu) of Tacabrutideg","Day 1",[29,33,37,40],{"measure":30,"description":31,"timeFrame":32},"Number of Participants with Adverse Events (AEs)","Number of participants with AEs, including adverse events with onset or increase in severity level on or after single dose administration.","Approximately 30 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 20 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 Electrocardiogram (ECG) Values","Number of participants with clinically significant ECG values from a 12-lead ECG, including new or worsened clinically significant abnormalities such as prolonged QT interval or other significant arrythmia.",{"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","Tacabrutideg is a type of medicine called a BTK degrader. BTK (Bruton's tyrosine kinase) is a protein that helps cancer cells survive. Tacabrutideg is designed to attach to the BTK protein and tag it for removal, so that the body's own cellular \"clean-up\" system breaks it down and clears it away. When more BTK is removed from the body, it interferes with the signals needed for the cancer cells to multiply and survive and may also reduce the chance of the cancer becoming resistant to treatment.\n\nThe purpose of this study is to look at the safety and blood levels of tacabrutideg in adults with 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 tacabrutideg by mouth with food and remain in the clinic for about 20 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\nThis study will enroll approximately 24 adults in the United States (up to 16 participants with liver impairment and 8 participants with normal liver function).\n\nThe overall time to participate in this study is approximately 8 weeks. Participants will make regular visits to the clinic for health checks, blood tests, tacabrutideg administration and monitoring, and follow-up.",[51,57,61],{"label":52,"type":53,"description":54,"interventionNames":55},"Group 1: Moderate Hepatic Impairment","EXPERIMENTAL","Participants with moderate hepatic impairment will receive a single dose of tacabrutideg on Day 1.",[56],"Drug: Tacabrutideg",{"label":58,"type":53,"description":59,"interventionNames":60},"Group 2: Normal Hepatic Function","Participants with normal hepatic function will receive a single dose of tacabrutideg on Day 1.",[56],{"label":62,"type":53,"description":63,"interventionNames":64},"Group 3: Severe Hepatic Impairment","Participants with severe hepatic impairment will receive a single dose of tacabrutideg on Day 1.",[56],[66],{"type":67,"name":68,"description":69,"armGroupLabels":70,"otherNames":71},"DRUG","Tacabrutideg","Single dose of tacabrutideg administered orally.",[52,58,62],[72],"BGB-16673",[74],{"name":75,"affiliation":5,"role":76},"Study Director","STUDY_DIRECTOR",[78],{"name":75,"role":79,"phone":80,"phoneExt":11,"email":81},"CONTACT","1.877.828.5568","clinicaltrials@beonemed.com",{"type":83,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100658732","phase-1-a-study-to-investigate-safety-tolerability-and-pharmacokinetics-of-tacabrutideg-bgb-16673-in-participants-with-moderate-and-severe-hepatic-impairment-100658732",false,"NCT07856004","A Study to Investigate Safety, Tolerability, and Pharmacokinetics of Tacabrutideg (BGB-16673) in Participants With Moderate and Severe Hepatic Impairment","A Phase 1, Open-Label, Parallel-Group, Single-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Tacabrutideg in Participants With Moderate and Severe Hepatic Impairment","General Inclusion Criteria:\n\n* Body Mass Index (BMI) between ≥ 18.0 and 40 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 must agree to use a condom during sexual intercourse and refrain from sperm donation for the duration of the study and for 30 days after the last dose of tacabrutideg. For nonsterile male participants with a female partner of childbearing potential, use of an additional highly effective method of contraception by the female partner is highly recommended during this period.\n\nInclusion Criteria for Moderate and Severe Hepatic Impairment Groups:\n\n* Meets National Cancer Institute-Organ Dysfunction Working Group (NCI-ODWG) criteria for moderate or severe hepatic impairment at screening:\n\n  * Moderate hepatic impairment: Total bilirubin \\> 1.5 to 3 × upper limit of normal (ULN), any aspartate aminotransferase (AST)\n  * Severe hepatic impairment: Total bilirubin \\> 3 × ULN, any 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* Clinical laboratory test results and physical examination findings within normal limits or judged as not clinically significant by the investigator\n\nGeneral Exclusion Criteria:\n\n* Prior exposure to any BTK protein degraders\n* Underlying medical conditions (including laboratory abnormalities) other than stable hepatic impairment\n* History of severe bleeding disorder or history of unexplained spontaneous bleeding requiring blood transfusion or other medical or surgical intervention\n* Positive urine drug screen or alcohol urine\u002Fbreath test\u002Fblood results at Screening or Check-in\n\nExclusion Criteria for Moderate and Severe Hepatic Impairment Groups:\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":96,"type":97},24,"ESTIMATED","INTERVENTIONAL",[100],"PHASE1","The goal of this study is to understand how the body processes tacabrutideg in adults with different levels of liver function (normal, moderate impairment, and severe impairment).",[103,104],"Hepatic Impairment","Healthy Adult Participants",[106,107],"tacabrutideg","pharmacokinetics","NOT_YET_RECRUITING","2026-09-29",{"date":111,"type":112},"2026-10-02","ACTUAL",{"date":114,"type":97},"2026-10-22",{"date":116,"type":97},"2027-07-31",{"name":5,"class":6}]