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.
Body Mass Index (BMI) between 18.0 and 42.0 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 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
Any clinically significant disease or condition that, in the opinion of the Investigator, would interfere with study participation, safety, or evaluation of study results
History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, as determined by the investigator
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)
Positive urine drug screen or alcohol urine/breath test/blood results at screening or check-in
Parallel
Sonrotoclax
DrugSingle dose administered orally.
Area under the plasma concentration-time curve (AUC) from time 0 to the last quantifiable concentration (AUC0-t) of Sonrotoclax
AUC from time 0 extrapolated to infinity (AUC0-inf) of Sonrotoclax
Maximum observed plasma concentration (Cmax) of Sonrotoclax
Time to reach maximum observed plasma concentration (Tmax) of Sonrotoclax
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.
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 Physical Examination Findings
Number of participants with clinically significant physical examination findings, including new or worsened clinically significant abnormalities.
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