NCT01924650撤回1 期
A Randomized, Open Label, Single Dose, 6 Treatment, 4-way Crossover Study in Healthy Subjects to Assess the Pharmacokinetics of Three Different Particle Sizes of PH-797804 Tablet With and Without the Solubilizing Agent Sodium Lauryl Sulphate (SLS)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- Pfizer
- 主要终点
- Time to Reach Maximum Observed Plasma Concentration (Tmax)
研究概览
简要总结
The purpose of this study is to investigate the effects of varying particle size on the pharmacokinetics of PH-797804
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
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects and/or healthy female subjects of non-child bearing potential between the ages of 18 and 55 years (inclusive). Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurements, 12-lead ECG and clinical laboratory tests.
- •Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight > 50 kg (110 lbs).
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.
- •History of regular alcohol consumption exceeding 14 drinks/week for males.
研究组 & 干预措施
PH-797804 PARTICLE SIZE 9-11UM
Experimental
干预措施: PH-797804 (Drug)
PH-797804 PARTICLE SIZE 9-11UM WITH SLS
Experimental
干预措施: PH-797804 (Drug)
PH-797804 PARTICLE SIZE <= 20UM
Experimental
干预措施: PH-797804 (Drug)
PH-797804 PARTICLE SIZE <= 20UM WITH SLS
Experimental
干预措施: PH-797804 (Drug)
PH-797804 PARTICLE SIZE <= 5UM
Experimental
干预措施: PH-797804 (Drug)
PH-797804 PARTICLE SIZE <= 5UM WITH SLS
Experimental
干预措施: PH-797804 (Drug)
结局指标
主要结局
Time to Reach Maximum Observed Plasma Concentration (Tmax)
时间窗: 0,2,3,4,5,6,8,12,24,48,72 hours post-dose
Area Under the Curve From Time Zero to Time 72 hours (AUC72)
时间窗: 0,2,3,4,5,6,8,12,24,48,72 hours post-dose
Area under the plasma concentration time-curve from zero to 72 hours (AUC72)
Maximum Observed Plasma Concentration (Cmax)
时间窗: 0,2,3,4,5,6,8,12,24,48,72 hours post-dose
次要结局
未报告次要终点
研究者
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