Safety and Pharmacokinetics of Zanubrutinib (BGB-3111) in Healthy Subjects and Those With Impaired Liver Function

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 Exclusion Criteria for Hepatic Impaired Subjects Only:

- Received a liver transplant

- Acute or exacerbating hepatitis

- Active Stage 3 or 4 hepatic encephalopathy

- Previously diagnosed with hepatocellular carcinoma, or a history of cholestatic liver
disease or biliary sepsis within the past 2 years.

- Additional Exclusion Criteria for Healthy Subjects Only: A positive Hepatitis B
surface antigen (HBsAg) or Hepatitis C test result.

- History of any clinically significant chronic and/or active hepatic disease.