临床试验/NCT00912431

NCT00912431已完成1 期

A Pharmacokinetic and Exploratory Biomarker Study of ABT-126 in the Cerebrospinal Fluid (CSF) of Healthy Subjects

Abbott1 个研究点分布在 1 个国家目标入组 10 人开始时间: 2009年6月最近更新: 2010年11月2日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Abbott
入组人数: 10
试验地点: 1
主要终点: Safety and Tolerability Assessments (i.e., ECG, clinical laboratory tests, vital signs, weight, AE assessment, physical examination and neurological examination)

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 objectives of this study are to determine the cerebrospinal fluid (CSF) levels of ABT-126 and to examine the effects of ABT-126 on exploratory biomarkers after administration of a single does of ABT-126 in healthy volunteers.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Crossover
主要目的: Treatment
盲法: Single (Participant)

入排标准

年龄范围: 18 Years 至 50 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•Healthy male or female subjects between 18 and 50 years of age

排除标准

•History of bleeding disorders or Deep Vein Thrombosis
•History of spinal surgery
•History of migraine headaches, or other types of headaches occuring more than 2 times per month, or history of spinal disc disease, or chronic, significant low back pain

研究组 & 干预措施

1

Experimental

干预措施: ABT-126 (Drug)

2

Placebo Comparator

干预措施: Placebo (Drug)

结局指标

主要结局

Safety and Tolerability Assessments (i.e., ECG, clinical laboratory tests, vital signs, weight, AE assessment, physical examination and neurological examination)

时间窗: Day 1 thru Day 4 in Periods 1 and 2

Pharmacokinetic samples

时间窗: Day 1 (up to 24-hour post dose) in Periods 1 and 2

Cerebrospinal Fluid samples

时间窗: Day 1 (up to 24-hour post dose) in Periods 1 and 2

次要结局

未报告次要终点

研究者

发起方

Abbott

申办方类型

Industry

研究点 (1)

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