NCT01009216已完成1 期
A Study to Evaluate the Cerebrospinal Fluid Pharmacokinetics and Pharmacodynamics of Multiple Doses of ABT-384 in Healthy Male Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 12
- 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 and brief neurological examinations)
研究概览
简要总结
The objectives of this study are to assess the cerebral spinal fluid (CSF) pharmacokinetics and the plasma/CSF pharmacokinetic/pharmacodynamic relationship of ABT-384 in healthy male 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 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age is between 18 and 55 years
- •Judged to be in a condition of general good health based on the results of medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG
排除标准
- •Use of protocol-prohibited medications within 2 weeks prior to study drug administration.
- •Positive urine drug screen for non-prescribed drugs of abuse including alcohol.
- •Receipt of any drug depot by injection within 30 days prior to study drug administration.
- •Receipt of any investigational product within 6 weeks prior to study drug administration.
- •History of significant sensitivity or allergy to any drug.
- •History of drug or alcohol abuse.
- •Positive test result for HAV, HBsAg, HCV or HIV.
- •Donation or loss of 550 mL or more blood volume or receipt of any blood product within 3 months prior to study drug administration.
- •Contraindication for lumbar puncture (e.g., lumbar scoliosis, coagulopathy, infected skin at puncture site)
- •Current enrollment in another clinical study.
研究组 & 干预措施
ABT-384
Experimental
干预措施: ABT-384 (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 and brief neurological examinations)
时间窗: Days -1 through 9
Assess Pharmacokinetics (i.e., ABT-384 and possible metabolite levels) and Pharmacodynamics (i.e., biomarkers of drug effect)
时间窗: Days 1, 4 through 9
次要结局
未报告次要终点
研究者
研究点 (1)
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