The Effect of Hepatic Impairment on the Pharmacokinetics of Alectinib: A Multiple-Center, Open-Label Study Following Single Oral Dosing of Alectinib to Subjects With Hepatic Impairment and Matched Healthy Subjects With Normal Hepatic Function

Hoffmann-La Roche2 个研究点分布在 2 个国家目标入组 28 人开始时间: 2015年12月4日最近更新: 2018年8月24日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Hoffmann-La Roche
入组人数: 28
试验地点: 2
主要终点: Maximum Observed Plasma Concentration (Cmax) of Total Alectinib

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is a multicenter, non-randomized, single-dose, open-label study conducted in male and surgically sterile or post-menopausal female participants with stable chronic hepatic impairment and in healthy participants matched by age, gender, and body weight to assess the effect of hepatic impairment on the pharmacokinetics of alectinib.

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 70 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•All Participants
•Body mass index between 18 to 35 kilograms per square meter (kg/m^2) inclusive and weight greater than (>) 50 kilograms (kg)
•Female participants must be surgically sterile or post-menopausal
•Male participants and their partners of child-bearing potential must be willing to use 2 effective methods of contraception, one of which must be a barrier method
•Participants with Hepatic Impairment
•Documented chronic stable liver disease (Child-Pugh Class A, B or C)

排除标准

•All Participants
•Pregnant or lactating women, males with female partners who are pregnant or lactating, or women of child bearing potential
•Positive test for drugs of abuse or alcohol
•Participation in an investigational drug or device study within 45 days or 5 half-lives (whichever time period is longer) or 6 months for biologic therapies prior to study drug administration
•History of hypersensitivity to any of the additives in the alectinib formulation
•Participants under judicial supervision, guardianship, or curatorship
•History of severe drug-related allergic reactions or drug-induced hepatotoxicity
•Healthy Participants
•Use of any medications (prescription or over-the-counter), within 2 weeks or 5 half-lives (whichever longer) prior to study drug administration
•Use of any herbal supplements or any metabolic inducers within 4 weeks, or 5 half-lives (whichever is longer) prior to study drug administration
•Participants with Hepatic Impairment
•Positive screening test for human immunodeficiency virus (HIV)
•History of liver transplantation
•Hepatocellular carcinoma or acute liver disease
•Severe ascites at screening or admission to the clinic
•Recent history (past 2 years) or current severe hepatic encephalopathy (Grade 3 or higher)
•Any evidence of progressive liver disease within the last 4 weeks
•Presence of surgically created or transjugular intrahepatic portal systemic shunts

研究组 & 干预措施

Alectinib: Moderate Hepatic Impairment

Experimental

Participants with moderate hepatic impairment (based on Child-Pugh score) will receive alectinib at a single oral dose of 300 milligrams (mg) on Day 1.

干预措施: Alectinib (Drug)

Alectinib: Severe Hepatic Impairment

Experimental

Participants with severe hepatic impairment (based on Child-Pugh score) will receive alectinib at a single oral dose of 300 mg on Day 1.

干预措施: Alectinib (Drug)

Alectinib: Normal Hepatic Function

Experimental

Participants with normal hepatic function will receive alectinib at a single oral dose of 300 mg on Day 1.

干预措施: Alectinib (Drug)