NCT01298505终止1 期
A Phase 1 Double-blind (3rd Party Open), Randomized, Placebo-controlled Study To Investigate The Safety And Toleration Of Multiple Oral Doses Of Pf-03654764 In Combination With Fexofenadine In Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Number of participants with adverse events as a measure of safety and tolerability.
研究概览
简要总结
The purpose of this study in heathy people is to investigate the safety, toleration and time course of PF-03654764 in the blood, following multiple doses given by mouth together with fexofenadine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects. (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- •A positive urine drug screen.
- •Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.
研究组 & 干预措施
PF-03654764 2.5mg plus fexofenadine 60mg
Experimental
干预措施: PF-03654764 2.5mg plus fexofenadine 60mg (Drug)
PF-03654764 5mg plus fexofenadine 60mg
Experimental
干预措施: PF-03654764 5mg plus fexofenadine 60mg (Drug)
placebo
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Number of participants with adverse events as a measure of safety and tolerability.
时间窗: 30 days
次要结局
- Plasma concentrations of PF-03654764 will be measured.(7 days)
研究者
研究点 (1)
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