Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 16 of 21 for:    BGB-3111

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03465059
Recruitment Status : Completed
First Posted : March 14, 2018
Last Update Posted : March 11, 2019
Sponsor:
Information provided by (Responsible Party):
BeiGene

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

Condition or disease Intervention/treatment Phase
Hepatic Insufficiency & Healthy Subjects Drug: Zanubrutinib Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open-label, Single-dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Zanubrutinib (BGB-3111) in Subjects With Varying Degrees of Hepatic Impairment
Actual Study Start Date : May 30, 2018
Actual Primary Completion Date : October 19, 2018
Actual Study Completion Date : October 19, 2018

Arm Intervention/treatment
Experimental: Normal Hepatic Function
Participants with normal hepatic function will be administered a single oral dose of Zanubrutinib (80 mg).
Drug: Zanubrutinib
A single oral dose of 80 mg Zanubrutinib will be administered.

Experimental: Mild Hepatic Impairment
Participants with mild hepatic impairment (Child-Pugh Class A, score of 5 to 6, inclusive) will be administered a single dose of Zanubrutinib (80 mg).
Drug: Zanubrutinib
A single oral dose of 80 mg Zanubrutinib will be administered.

Experimental: Moderate Hepatic Impairment
Participants with moderate hepatic impairment (Child-Pugh Class B, score of 7 to 9, inclusive) will be administered a single dose of Zanubrutinib (80 mg).
Drug: Zanubrutinib
A single oral dose of 80 mg Zanubrutinib will be administered.

Experimental: Severe Hepatic Impairment
Participants with severe hepatic impairment (Child-Pugh Class C, score of 10 to 15, inclusive) will be administered a single dose of Zanubrutinib (80 mg).
Drug: Zanubrutinib
A single oral dose of 80 mg Zanubrutinib will be administered.




Primary Outcome Measures :
  1. Plasma concentration of Zanubrutinib (BGB-3111) to evaluate protocol specified PK parameters [ Time Frame: Days 1, 2 & 3 ]
    Plasma concentration of Zanubrutinib (BGB-3111) to evaluate Area Under the Plasma Concentration-Time Curve (AUC) of Zanubrutinib

  2. Plasma concentration of Zanubrutinib (BGB-3111) to evaluate protocol specified PK parameters [ Time Frame: Days 1, 2 & 3 ]
    Plasma concentration of Zanubrutinib (BGB-3111) to evaluate Maximum Observed Plasma Concentration (Cmax) of Zanubrutinib


Secondary Outcome Measures :
  1. Treatment-Emergent Adverse Events (AE) [ Time Frame: up to Day 17 ]
    Percentage of Participants with Treatment-Emergent Adverse Events (AE)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03465059


Locations
Layout table for location information
United States, Florida
University of Miami
Miami, Florida, United States, 33124
Orlando Clinical Research Center
Orlando, Florida, United States, 32809
Sponsors and Collaborators
BeiGene

Layout table for additonal information
Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT03465059     History of Changes
Other Study ID Numbers: BGB-3111-107
First Posted: March 14, 2018    Key Record Dates
Last Update Posted: March 11, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by BeiGene:
BGB-3111
Zanubrutinib
pharmacokinetics
healthy subjects
hepatic impairment

Additional relevant MeSH terms:
Layout table for MeSH terms
Hepatic Insufficiency
Liver Failure
Liver Diseases
Digestive System Diseases
Zanubrutinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action