跳至主要内容
临床试验/NCT01437384
NCT01437384已完成1 期

An Open-label, Single-sequence, Four-treatment Period Study to Evaluate Pharmacokinetic and Pharmacodynamic Interactions Between E5501 and Verapamil, and E5501 and Cyclosporine, Known P-glycoprotein Inhibitors in Healthy Subjects

Eisai Inc.1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2011年9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
36
试验地点
1
主要终点
Plasma concentrations of E5501

研究概览

简要总结

36 healthy adult men and women will be enrolled with the goal of having 24 subjects complete the entire study. The study will consist of a pre-treatment phase and a treatment phase. The pre-treatment phase will include screening and baseline period 1. The treatment phase consists of 4 treatment period: Treatment Period 1 - administration of the first E5501 oral dose; Treatment Period 2 - administration of verapamil and the second E5501 oral dose; Treatment Period 3 - administration of the third E5501 dose; Treatment Period 4 - concomitant administration of cyclosporine and the fourth E5501 dose. A baseline period will precede each treatment period. The screening period will be up to 13 days in duration. After fulfilling screening requirements, subjects will check into the clinic on Day -1 for baseline assessments. They will be domiciled in the clinical testing facility for 6 days for Treatment Periods 1, 3, and 4 and will return intermittently for study procedures for 8 outpatient visits. They will be domiciled in the clinical testing facility for at least 14 days for Treatment Period 2 and will return intermittently for study procedures for 7 outpatient visits.

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 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

E5501 plus minus verapamil; plus minus cyclosporine

Experimental

干预措施: E5501 (Drug)

结局指标

主要结局

Plasma concentrations of E5501

时间窗: Periodically over the course of Days 1-11

次要结局

  • Platelet counts(Periodically over the course of Days 1-34)

研究者

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

研究点 (1)

Loading locations...

相似试验