NCT03465059已完成1 期
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
BeiGene2 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2018年5月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Plasma concentration of Zanubrutinib (BGB-3111) to evaluate protocol specified PK parameters
研究概览
简要总结
This study is designed to evaluate the safety and pharmacokinetics of zanubrutinib in subjects with impaired liver function in comparison with healthy subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Normal Hepatic Function
Experimental
Participants with normal hepatic function will be administered a single oral dose of Zanubrutinib (80 mg).
干预措施: Zanubrutinib (Drug)
Mild Hepatic Impairment
Experimental
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).
干预措施: Zanubrutinib (Drug)
Moderate Hepatic Impairment
Experimental
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).
干预措施: Zanubrutinib (Drug)
Severe Hepatic Impairment
Experimental
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).
干预措施: Zanubrutinib (Drug)
结局指标
主要结局
Plasma concentration of Zanubrutinib (BGB-3111) to evaluate protocol specified PK parameters
时间窗: Days 1, 2 & 3
Plasma concentration of Zanubrutinib (BGB-3111) to evaluate Maximum Observed Plasma Concentration (Cmax) of Zanubrutinib
次要结局
- Treatment-Emergent Adverse Events (AE)(up to Day 17)
研究者
研究点 (2)
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