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临床试验/NCT02199392
NCT02199392已完成1 期

A Pharmacokinetic Study to Assess the Influence of P-glycoprotein Inhibition and Simultaneous CYP3A4 and P-glycoprotein Induction on E7080 Pharmacokinetics Following Single Dose Oral Administration of 24 mg E7080 to Healthy Volunteers

Eisai Inc.0 个研究点目标入组 15 人开始时间: 2011年11月最近更新:
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
Eisai Inc.
入组人数
15
主要终点
Pharmacokinetics of lenvatinib: AUC(0-inf)

研究概览

简要总结

The purpose of this single-dose, open-label, sequential, three-period study in 15 healthy subjects was to assess the influence of P-glycoprotein inhibition and simultaneous CYP3A4 and P-glycoprotein induction on lenvatinib pharmacokinetics following single dose oral administration of 24 mg lenvatinib to healthy volunteers.

详细描述

This is a single-dose, open-label, sequential, three-period study in 15 healthy subjects to assess the influence of P-glycoprotein inhibition and simultaneous CYP3A4 and P-glycoprotein induction on lenvantinib pharmacokinetics following single dose oral administration of 24 mg lenvatinib to healthy volunteers. The study will consist of two phases: Pretreatment and Treatment. The Pretreatment Phase will have two periods: Screening and Baseline 1. The purpose of the Screening Period is to obtain informed consent and to establish protocol eligibility. The purpose of the Baseline 1 is to confirm protocol eligibility. The Treatment Phase will have three periods: Treatment Period 1, Treatment Period 2, and Treatment Period 3 with a Baseline 2 assessment prior to Treatment Period 2 and a Baseline 3 assessment prior to Treatment Period 3. The purpose of Baselines 2 and 3 are to confirm continued protocol eligibility. In the Treatment Phase, subjects will take a single oral dose of 24 mg lenvatinib on three separate occasions (Period 1, Day 1; Period 2, Day 15; and Period 3, Day 43). In Period 2, Day 15, subjects will also take a single oral dose of 600 mg po rifampin. In Period 3, subjects will receive 600 mg rifampin po daily for 21 days (Period 3, Days 29 to 49). On Day 43 of Period 3, subjects will take 24 mg lenvatinib in addition to the rifampin.

研究设计

研究类型
Interventional
分配方式
Na
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 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Lenvatinib 24 mg

Experimental

The Pretreatment Phase will have two periods: Screening and Baseline 1. The Treatment Phase will have three periods: Treatment Period 1, Treatment Period 2, and Treatment Period 3 with a Baseline 2 assessment prior to Treatment Period 2 and a Baseline 3 assessment prior to Treatment Period 3. In the Treatment Phase, subjects will take a single oral dose of 24 mg lenvatinib on three separate occasions (Period 1, Day 1; Period 2, Day 15; and Period 3, Day 43). In Period 2, Day 15, subjects will also take a single oral dose of 600 mg po rifampin. In Period 3, subjects will receive 600 mg rifampin po daily for 21 days (Period 3, Days 29 to 49). On Day 43 of Period 3, subjects will take 24 mg lenvatinib in addition to the rifampin.

干预措施: Lenvatinib (Drug)

结局指标

主要结局

Pharmacokinetics of lenvatinib: AUC(0-inf)

时间窗: Predose and up to 168 hours post dose

Pharmacokinetics of lenvatinib: Cmax

时间窗: Predose and up to 168 hours post dose

次要结局

  • Safety as measured by laboratory values(Predose and up to 168 hours post dose)
  • Safety as measured by vital signs(Predose and up to 168 hours post dose)
  • Safety as measured by all Adverse Events (AEs)(Predose and up to 168 hours post dose)
  • Pharmacokinetics of lenvatinib: AUC(0-inf)(Predose and up to 168 hours post dose)
  • Safety as measured by ECGs(Predose and up to 168 hours post dose)
  • Safety as measured by physical examinations(Predose and up to 168 hours post dose)

研究者

发起方
Eisai Inc.
申办方类型
Industry
责任方
Sponsor

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