临床试验/NCT00681915

NCT00681915已完成1 期

A Phase I, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD7325 When Given in Multiple Ascending Oral Doses in Healthy Male and Healthy Female Subjects of Non-child Bearing Potential

AstraZeneca1 个研究点分布在 1 个国家目标入组 48 人开始时间: 2008年3月最近更新: 2010年12月9日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: AstraZeneca
入组人数: 48
试验地点: 1
主要终点: To assess the safety and tolerability of multiple ascending oral doses of AZD7325 compared to placebo by assessment of adverse events, vital signs, physical examinations, laboratory parameters, and ECGs

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

This is a study to evaluate safety, tolerability, PK and PD effects of orally administered AZD7325 after single and repeated ascending doses.

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: 18 Years 至 55 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•Female subjects must be of non-child bearing potential.

排除标准

•Clinically significant illness within 2 weeks before the study start.
•Enrollment in another concurrent investigational study or intake of an investigational drug within 30 days or intake of an investigational drug within a period of 5 half lives of that drug prior to the screening visit
•Blood loss in excess of 200 mL within 30 days of Day -2, in excess of 400 mL within 90 days of Day -2, or in excess of 1200 mL within 1 year of Day -2
•Clinically relevant abnormalities in physical examinations, vital signs, ECG, clinical chemistry, hematology or urinalysis

研究组 & 干预措施

1

Experimental

干预措施: AZD7325 (Drug)

结局指标

主要结局

To assess the safety and tolerability of multiple ascending oral doses of AZD7325 compared to placebo by assessment of adverse events, vital signs, physical examinations, laboratory parameters, and ECGs

时间窗: Alssessments are made at each visit, at least daily, during the study.

次要结局

Evaluation and characterization of the pharmacokinetics of AZD7325 when given orally in multiple ascending doses(Blood samples will be taken during the study.)
Evaluation of the pharmacodynamic effects of AZD7325(Test batteries will be performed at specified times both before and following study drug administration.)
Identification of genes that influence the disposition, efficacy, safety and tolerability of AZD7325.(A single blood sample will be obtained.)

研究者

发起方

AstraZeneca

申办方类型

Industry

研究点 (1)

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