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

Completed · Phase 1

Conditions studied: Hepatic Insufficiency & Healthy Subjects

In brief

This study is designed to evaluate the safety and pharmacokinetics of zanubrutinib in subjects with impaired liver function in comparison with healthy subjects

Key facts

Study ID

NCT03465059

Run by

BeiGene

People needed

29

Starts

2018-05-30

Expected to finish

2018-10-19

Last updated by the study team

2020-04-24

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Miami — Miami, Florida, United States
• Orlando Clinical Research Center — Orlando, Florida, United States

Full record on ClinicalTrials.gov

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