NCT00991016终止1 期
A Phase 1 Randomized, Double Blind (3rd Party Open), Placebo Controlled Combined Single And Multiple Dose Safety, Tolerability And Pharmacokinetics Study Of Orally Administered PF-04805712 In Healthy Volunteers
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
- 61
- 试验地点
- 1
- 主要终点
- Safety: Adverse events, vital signs measurements, telemetry, 12 lead ECGs, blood and urine safety tests.
研究概览
简要总结
To assess the safety and tolerability of escalating single and multiple doses of the compound in healthy volunteers
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 males and females of non-childbearing potential.
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).
研究组 & 干预措施
PF-04805712
Experimental
干预措施: PF-04805712 (Drug)
结局指标
主要结局
Safety: Adverse events, vital signs measurements, telemetry, 12 lead ECGs, blood and urine safety tests.
时间窗: 12 weeks
Pharmacokinetics: PK parameters will be determined after single dose, fasted and (at one dose) fed, and at steady state (fasted or fed depending on single dose data).
时间窗: 12 weeks
次要结局
- Pharmacodynamics: Urinary LTE4(12 weeks)
研究者
研究点 (1)
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