An Open-Label, Multicenter, Pharmacokinetic Study of PCI-32765 in Subjects With Varying Degrees of Hepatic Impairment
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Maximum plasma concentration of PCI-32765
研究概览
简要总结
The purpose of this study is to evaluate the pharmacokinetics (how the drug concentrations change over time) of PCI 32765 in participants with mild, moderate, or severe hepatic impairment.
详细描述
This is an open-label (all people know the identity of the intervention), single-dose, multi-center (study conducted at multiple sites), non-randomized study to access the pharmacokinetics of PCI-32765 in participants who either have mild, moderate, or severe hepatic impairment or qualify for the control group (normal liver function). The study mainly consists of 3 phases: screening phase (within 21 days prior to the first dose of study medication), treatment phase, and a follow up phase (10 to 12 days after the last dose of study medication). In the treatment phase, participants will receive single oral dose of PCI-32765 on Day 1. Liver impairment will be classified according to the Child-Pugh Classification of Severity of Liver Disease, as: normal, mild, moderate, and severe. Total 30 participants (24 with hepatic impairment [6 mild, 9 moderate and 9 severe] at baseline and 6 in the control group according to Child-Pugh criteria) will be enrolled. Participants in the control group will be enrolled after the participants with mild or moderate hepatic impairment have completed the study. Safety evaluations for adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination will be monitored throughout the study. The total duration of study for each participant will be approximately for 29 to 33 days.
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
- •Stable hepatic function as confirmed by the serum bilirubin and transaminase levels measured during screening and those measured within 48 hours prior to PCI-32765 administration
- •Must be hepatically impaired as defined by the Child-Pugh classification of severity of liver disease
- •Control group must have good health with normal liver function
- •Participants with controlled hypertension and those with problems directly associated with the primary diagnosis of hepatic impairment
- •Concomitant medications to treat underlying disease states or medical conditions related to hepatic impairment are allowed
- •Agrees to protocol-defined use of effective contraception
排除标准
- •Clinically significant renal laboratory findings including serum creatinine more than 1.5 x the upper limit of normal (ULN) and/or calculated creatinine clearance of less than 60 ml per minute per 1.73 square meter
- •Clinically significant abnormal laboratory tests, physical examination, vital signs or electrocardiogram at screening or at admission to the study center
- •Antiviral therapy for active hepatitis infection at time of screening
- •Use of any anti-coagulation therapy including vitamin K antagonists, low molecular weight heparin, or other anticoagulants
研究组 & 干预措施
Patients with mild hepatic function
Patients will receive PCI-32765 140 mg, orally, as a single dose, on Day 1.
干预措施: PCI-32765 (Drug)
Patients with moderate hepatic function
Patients will receive PCI-32765 140 mg, orally, as a single dose, on Day 1.
干预措施: PCI-32765 (Drug)
Patients with severe hepatic function
Patients will receive PCI-32765 140 mg, orally, as a single dose, on Day 1.
干预措施: PCI-32765 (Drug)
Patients with normal hepatic function
Patients will receive PCI-32765 140 mg, orally, as a single dose, on Day 1.
干预措施: PCI-32765 (Drug)
结局指标
主要结局
Maximum plasma concentration of PCI-32765
时间窗: Predose, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 16 hours, 24 hours, 36 hours, 48 hours, 72 hours, and 96 hours
Area under the plasma concentration of PCI-32765
时间窗: Predose, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 16 hours, 24 hours, 36 hours, 48 hours, 72 hours, and 96 hours
次要结局
- Number of participants with adverse events(up to Day 5)