NCT00892021撤回1 期
An Ascending Multiple-Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NSA-789 Administered Orally to Subjects With Schizophrenia or Schizoaffective Disorder
Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点开始时间: 2009年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 主要终点
- Safety as measured by adverse events, monitoring of safety variables (ECGs, vital signs, laboratory test results)
研究概览
简要总结
This study will evaluate the safety of multiple doses of NSA-789 in subjects with schizophrenia or schizoaffective disorder. This study will also assess how NSA-789 is absorbed and eliminated, and its effect, if any, on the brain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
NSA-789
Experimental
Active study drug
干预措施: NSA-789 (Drug)
Placebo
Placebo Comparator
Inactive study drug
干预措施: Placebo (Drug)
结局指标
主要结局
Safety as measured by adverse events, monitoring of safety variables (ECGs, vital signs, laboratory test results)
时间窗: 6 months
次要结局
- Tolerability as measured through the reporting of adverse events; Pharmacokinetic as measured by the concentrations of NSA-789 in blood; Pharmacodynamics as measured by the results of psychiatric ratings and neurologic evaluations.(6 months)
研究者
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