A Phase 1, Open-Label, Single-Dose, Pharmacokinetic and Safety Study of E7080 (24 mg) Administered to Subjects With Mild, Moderate, and Severe Renal Impairment and to Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Eisai Inc.
- 入组人数
- 26
- 主要终点
- Pharmacokinetics of lenvatinib: Cmax
研究概览
简要总结
The purpose of this multicenter, open-label, non-randomized, single, oral dose, sequential-cohort study was to determine pharmacokinetics and safety of lenvatinib (24 mg) administered to healthy subjects and to subjects with renal impairment.
详细描述
This is a multicenter, open-label, non-randomized, single-dose, sequential-cohort trial in subjects with renal impairment and healthy subjects. The study consists of two phases: A Pretreatment Phase and a Treatment Phase. The two periods in the Pretreatment Phase are: (1) the Screening Period (lasting up to 29 days), and (2) the Baseline Period (one day). The Treatment Period of the Treatment Phase lasts 8 days. The study will enroll a sufficient number of subjects so that 24 to 26 subjects complete the study. This will include six subjects with mild renal impairment (Group 1), six subjects with moderate renal impairment (Group 2), four to six subjects with severe renal impairment (Group 3) and eight subjects with normal renal function (Group 4). Subjects determined to be eligible for the protocol will receive a single 24-mg oral dose of E7080 on Day 1. Subjects will be discharged from clinical site on Day 8.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Lenvatinib
Lenvatinib will be taken as a single dose of 24 mg consisting of 2 x 10 mg and 1 x 4 mg capsules. Treatment will be administered orally with 240 mL of water following a 10-hour overnight fast.
干预措施: Lenvatinib (Drug)
结局指标
主要结局
Pharmacokinetics of lenvatinib: Cmax
时间窗: Day 1 to Day 8
Pharmacokinetics of lenvatinib: AUC(0-t)
时间窗: Day 1 to Day 8
Pharmacokinetics of lenvatinib: AUC(0-inf)
时间窗: Day 1 to Day 8
次要结局
- Safety as Measured by Outcome of serious adverse events (SAEs)(Screening, Baseline and Treatment period (Day 1 to Day 8))
- Safety as Measured by performance of physical examinations.(Screening, Baseline and Treatment period (Day 1 to Day 8))
- Safety as Measured by ECGs(Screening, Baseline and Treatment period (Day 1 to Day 8))
- Safety as Measured by Laboratory Values(Screening, Baseline and Treatment period (Day 1 to Day 8))
- Safety as Measured by vital signs(Screening, Baseline and Treatment period (Day 1 to Day 8))
- Safety as Measured by Outcome of all Adverse Events (AEs)(Screening, Baseline and Treatment period (Day 1 to Day 8))
- Safety as Measured by Outcome of treatment-emergent AEs (TEAEs)(Screening, Baseline and Treatment period (Day 1 to Day 8))