Hepatic Insufficiency & Healthy Subjects Clinical Trial
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
| Verified date | April 2020 |
| Source | BeiGene |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This study is designed to evaluate the safety and pharmacokinetics of zanubrutinib in subjects with impaired liver function in comparison with healthy subjects
| Status | Completed |
| Enrollment | 29 |
| Est. completion date | October 19, 2018 |
| Est. primary completion date | October 19, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Miami | Miami | Florida |
| United States | Orlando Clinical Research Center | Orlando | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| BeiGene |
United States,
Ou YC, Preston RA, Marbury TC, Tang Z, Novotny W, Tawashi M, Li TK, Sahasranaman S. A phase 1, open-label, single-dose study of the pharmacokinetics of zanubrutinib in subjects with varying degrees of hepatic impairment. Leuk Lymphoma. 2020 Feb 7:1-9. doi — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Plasma concentration of Zanubrutinib (BGB-3111) to evaluate protocol specified PK parameters | Plasma concentration of Zanubrutinib (BGB-3111) to evaluate Area Under the Plasma Concentration-Time Curve (AUC) of Zanubrutinib | Days 1, 2 & 3 | |
| Primary | Plasma concentration of Zanubrutinib (BGB-3111) to evaluate protocol specified PK parameters | Plasma concentration of Zanubrutinib (BGB-3111) to evaluate Maximum Observed Plasma Concentration (Cmax) of Zanubrutinib | Days 1, 2 & 3 | |
| Secondary | Treatment-Emergent Adverse Events (AE) | Percentage of Participants with Treatment-Emergent Adverse Events (AE) | up to Day 17 |