临床试验/NCT01027234

NCT01027234终止1 期

A Phase I, Single-center, Randomized, Double-blind, Placebo-controlled Single-ascending Dose, First Time Into Man Study to Assess the Safety, Tolerability, and Pharmacokinetics (Part A) and an Open-label Assessment of the Effect of Food on the Pharmacokinetics (Part B) of Orally Administered AZD8418

AstraZeneca1 个研究点分布在 1 个国家目标入组 40 人开始时间: 2009年11月最近更新: 2010年5月26日

适应症

干预措施

试验速览

阶段: 1 期
状态: 终止
发起方: AstraZeneca
入组人数: 40
试验地点: 1
主要终点: To assess the safety and tolerability of AZD8418 following the oral administration of single ascending doses and to estimate the maximum tolerated dose in healthy volunteers.

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 main purpose of this study is to assess the safety and tolerability of AZD8418 after single increasing oral doses.

Another purpose of this study is to evaluate the pharmacokinetics (also called PK - how the study drug enters and leaves the body and how your body acts on the study drug) of AZD8418. Part B of the study will assess the effect of food on the safety and pharmacokinetics of AZD8418.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Single Group
主要目的: Basic Science
盲法: Double (Participant, Investigator)

入排标准

年龄范围: 18 Years 至 45 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•Healthy male volunteers
•Healthy female volunteers of non-childbearing potential

排除标准

•History of any clinically significant medical, neurologic, or psychiatric disease (including repeated episodes of major depression) or a disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation
•History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator, or history of hypersensitivity to drugs with a similar chemical structure or class to AZD8418

研究组 & 干预措施

1

Experimental

干预措施: AZD8418 (Drug)

2

Placebo Comparator

干预措施: Placebo (Drug)

结局指标

主要结局

To assess the safety and tolerability of AZD8418 following the oral administration of single ascending doses and to estimate the maximum tolerated dose in healthy volunteers.

时间窗: Safety assessments will be obtained daily throughout the study

次要结局

To characterise the pharmacokinetics of AZD8418 and its metabolites in plasma and urine, and provisionally assess the dose proportionality of the pharmacokinetics following administration of single ascending doses of AZD8418.(samples will be obtained pre and post dose)
To assess the effect of food on the safety and pharmacokinetic profile of AZD8418 and its metabolites.(samples will be obtained pre and post dose)

研究者

发起方

AstraZeneca

申办方类型

Industry

研究点 (1)

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