A Study to Investigate the Process by Which ABT-614 is Absorbed, Distributed, Metabolized and Eliminated in Humans
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Safety and Tolerability Assessments (e.g., clinical laboratory tests, vital signs, adverse event assessment, physical examination)
研究概览
简要总结
The objective of this study is to determine the amount of ABT-614 in the cerebral spinal fluid and blood after administration of a single dose and after administration of daily doses for 14 days in healthy volunteers.
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 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects between 18 and 40 years of age
排除标准
- •History of bleeding disorders or deep vein thrombosis (DVT)
- •Previous gastrointestinal (GI) surgery or chronic GI disease
- •History of spinal surgery
- •History of significant, chronic low back pain
- •History of frequent headaches
研究组 & 干预措施
Single Dose (Part 1)
干预措施: ABT-614 (Drug)
Multiple Dose (Part 2)
干预措施: ABT-614 (Drug)
结局指标
主要结局
Safety and Tolerability Assessments (e.g., clinical laboratory tests, vital signs, adverse event assessment, physical examination)
时间窗: One day before dosing through day of last dose and up to 72 hrs post-single dose or up to 14 days post-multiple doses
ABT-614 levels in cerebral spinal fluid
时间窗: 0-24 hrs after single dose or 0-24 hrs after last dose of mulitple-dosing regimen
ABT-614 levels in blood (plasma)
时间窗: 0-24 hrs after single dose or 0-24 hrs after last dose of mulitple-dosing regimen
次要结局
未报告次要终点