NCT00756743已完成1 期
A Phase I Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of PF-04802540 After Multiple Oral Dose Administration To Healthy Adult Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pharmacokinetics
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of multiple ascending doses of PF-04802540 administered orally to healthy adult subjects.
详细描述
Evaluation of safety and pharmacokinetics
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 54 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males or females of non-childbearing capacity aged 21 to 55 years inclusive at screening.
- •Body mass index in the range of 18 to 30 kg/m2 and body weight>45 kg.
- •Healthy as determined by the investigator on the basis of screening evaluation.
排除标准
- •Use of prescription or nonprescription drugs
- •Any condition possibly affecting drug absorption
研究组 & 干预措施
PF-04802540
Experimental
干预措施: PF-04802540 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Pharmacokinetics
时间窗: 12 days
Adverse events
时间窗: 12 days
Safety assessments: vital signs, ECG, physical examination, laboratory tests
时间窗: 12 days
次要结局
- No secondary outcomes measures.(Timeframe N/A)
研究者
研究点 (1)
Loading locations...
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