临床试验/NCT01294540

NCT01294540已完成1 期

A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral Doses of E2609 in Healthy Subjects and an Elderly Cohort

Eisai Inc.1 个研究点分布在 1 个国家目标入组 73 人开始时间: 2010年12月最近更新: 2013年8月29日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Eisai Inc.
入组人数: 73
试验地点: 1
主要终点: Safety and tolerability as evidenced by the number of subjects with adverse events

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

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of E2609 when administered as single doses to healthy adult volunteers and healthy elderly subjects. The study will consist of 2 parts:(1) a single dose in healthy adult volunteers, at doses up to 800 mg or the maximum dose that can be tolerated, (2) a single dose of 50 mg in healthy elderly volunteers.

详细描述

The study will consist of 2 parts: (1) a single dose in healthy adult volunteers, at doses up to 100 mg or the maximum dose that can be tolerated, (2) a single dose of 25 mg or lower in healthy elderly volunteers.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Single Group
主要目的: Treatment
盲法: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围: 30 Years 至 85 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

Placebo Comparator: 2

Placebo Comparator

干预措施: Placebo (Drug)

结局指标

主要结局

Safety and tolerability as evidenced by the number of subjects with adverse events

时间窗: 38 days

次要结局

To assess the pharmacokinetics (PK) of E2609 in plasma and urine following administration of single oral doses(4 days)

研究者

发起方

Eisai Inc.

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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