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).
Body Mass Index (BMI) between ≥ 18.0 and 40 kg/m², inclusive
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
Female participants of non-childbearing potential who meet any of the following criteria: surgically sterile or postmenopausal
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.
Prior exposure to any BTK protein degraders
Underlying medical conditions (including laboratory abnormalities) other than stable hepatic impairment
History of severe bleeding disorder or history of unexplained spontaneous bleeding requiring blood transfusion or other medical or surgical intervention
Positive urine drug screen or alcohol urine/breath test/blood results at Screening or Check-in
Parallel
Tacabrutideg
DrugSingle dose of tacabrutideg administered orally.
Area under the plasma concentration-time curve (AUC) from time 0 to the last quantifiable concentration (AUC0-tlast) of Tacabrutideg
AUC from time 0 extrapolated to infinity (AUC0-∞) of Tacabrutideg
Maximum observed plasma concentration (Cmax) of Tacabrutideg
Time to reach maximum observed plasma concentration (Tmax) of Tacabrutideg
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.
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.
Number of Participants with Clinically Significant Vital Signs Measurements
Vital signs include pulse rate, body temperature, and blood pressure.
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.
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