Hepatic Insufficiency & Healthy Subjects
Conditions
Keywords
BGB-3111, Zanubrutinib, pharmacokinetics, healthy subjects, hepatic impairment
Brief summary
This study is designed to evaluate the safety and pharmacokinetics of zanubrutinib in subjects with impaired liver function in comparison with healthy subjects
Interventions
DRUGZanubrutinib
A single oral dose of 80 mg Zanubrutinib will be administered.
Sponsors
BeiGene
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Male and/or female subjects in good health as determined by past medical history, physical examination, vital signs, ECG and laboratory tests at screening. * Subjects must have a body mass index (BMI) between 18 and 40 kg/m2 to participate at screening. * Female subject must be of non-childbearing potential, i.e. surgically sterile at least 6 months prior to screening with supportive clinical documentation OR post-menopausal must have no regular menstrual bleeding for at least 12 months prior to inclusion. Menopause will be confirmed by a plasma FSH level of \>40 IU/L * Male subjects must agree to practice 2 highly effective methods of birth control at least one method must be barrier technique. Additional Inclusion Criteria for Healthy Subjects Only: * In good health as determined by past medical history, physical examination, vital signs, ECG, and laboratory tests at screening; subjects without diseases/conditions * Matched with a hepatic impaired patient (mild, moderate or severe, as applicable) using the following criteria: sex, age ±10 years and body mass index (BMI)± 10 kilograms Additional Inclusion Criteria for Hepatic Impaired Subjects Only: * History of cirrhosis with supportive documentation (ultrasonography, computed tomography scan, liver biopsy, magnetic resonance imaging, clinical laboratory tests results or physical signs consistent with a clinical diagnosis of liver cirrhosis. * Child-Pugh Clinical Assessment Score consistent with degree of hepatic impairment. * Blood pressure of 90 to 155 mmHg (systolic) and 50 to 100 mmHg (diastolic). * Otherwise considered healthy in general as determined by physical examination findings and laboratory assessments within normal limits.
Exclusion criteria
* Subjects with a clinically relevant history or presence of any clinically significant disease. * History of drug or alcohol abuse within the 12 months prior to dosing. * A positive human immunodeficiency virus (HIV) Type 1 or 2 test result at screening. * History of blood donation of 500 mL or more of blood within 2 months prior to screening * A positive tuberculosis test result. Additional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma concentration of Zanubrutinib (BGB-3111) to evaluate protocol specified PK parameters | Days 1, 2 & 3 | Plasma concentration of Zanubrutinib (BGB-3111) to evaluate Area Under the Plasma Concentration-Time Curve (AUC) of Zanubrutinib |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment-Emergent Adverse Events (AE) | up to Day 17 | Percentage of Participants with Treatment-Emergent Adverse Events (AE) |
Countries
United States
Outcome results
None listed