NCT00529646已完成1 期
A Randomized, Double-Blind, Placebo-Controlled, Single-Dose Escalation Study to Assess the Tolerability, Pharmacokinetics, and Pharmacodynamics of APD791 Administered to Healthy Adult Subjects
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Safety measures to include adverse events, vital signs, 12-lead ECGs, physical examinations, and clinical lab parameters
研究概览
简要总结
The APD791-001 study is designed primarily to evaluate the safety and tolerability of APD791 when administered as a single oral dose to healthy adult subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult men and women, ages 19-45
- •Non smokers
排除标准
- •History of a bleeding disorder
- •Recently donated blood or had significant blood loss
- •Current use of a prescription medication
- •Pregnant females
结局指标
主要结局
Safety measures to include adverse events, vital signs, 12-lead ECGs, physical examinations, and clinical lab parameters
次要结局
- Pharmacokinetic and pharmacodynamic assessments
研究者
研究点 (1)
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