NCT03860506已完成1 期
A Double-Blind, Placebo-Controlled, Randomized, Single-Dose, 2-Period Crossover Study of the Pharmacodynamics of Orally Administered PSI-697 in Healthy Subjects Who Smoke
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
- Pfizer
- 入组人数
- 30
- 主要终点
- reduction of platelet monocyte aggregates
研究概览
简要总结
This is a single dose inpatient and outpatient study to test whether an effect on the ability of platelets to stick to white blood cells in subjects who smoke.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double
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
- •Inclusion Criteria:
- •Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12?lead electrocardiogram (ECG).
- •Smoker of at least 1 pack or more of cigarettes per day (20 plus or minus 3 cigarettes) for more than 1 year as determined by history.
排除标准
- •Exclusion Criteria:
- •Any diagnosed bleeding disorder.
- •Any major surgical procedure within 6 months before study day
- •Any history of major bleeding (eg, bleeding peptic ulcer) within 1 year before study day 1.
研究组 & 干预措施
PSI-697
Experimental
干预措施: PSI-697 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
reduction of platelet monocyte aggregates
时间窗: 2 days
次要结局
未报告次要终点
研究者
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