A Phase 1 Single-dose Open Label 3-way Crossover Study To Evaluate The Bioavailability Of A Spray Dried Dispersion Solid Dose Formulation Of Pf-06260414 Relative To A Suspension Formulation Under Fasted Conditions And The Effect Of Food On The Bioavailability Of The Pf-06260414 Spray Dried Dispersion Solid Formulation In Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- Pfizer
- 试验地点
- 1
- 主要终点
- Single dose pharmacokinetics under fasted condition: AUClast of PF- 06260414 formulations
研究概览
简要总结
The current study will investigate the relative bioavailability of a spray dried dispersion solid dose formulation of PF 06260414 administered as a single oral dose of 30 mg of PF 06260414 relative to a single oral dose of 30 mg of PF 06260414 administered as a nanosuspension under fasted or fed conditions in healthy adult subjects.
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 and/or female subjects of non childbearing potential between the ages of 18 and 55 years, inclusive.
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
- •Any condition possibly affecting drug absorption (eg, gastrectomy)
研究组 & 干预措施
Open label single dose crossover study of PF-06260414
This will be a Phase 1, open label, randomized, single dose, 3 period, 3 way crossover study to evaluate the relative bioavailability of solid dose formulation of PF 06260414 under fasted conditions compared to the nanosuspension under fasted conditions
干预措施: PF 06260414 solid dose formulation (Drug)
Open label single dose crossover study of PF-06260414
This will be a Phase 1, open label, randomized, single dose, 3 period, 3 way crossover study to evaluate the relative bioavailability of solid dose formulation of PF 06260414 under fasted conditions compared to the nanosuspension under fasted conditions
干预措施: PF-06260414 nanosuspension (Drug)
结局指标
主要结局
Single dose pharmacokinetics under fasted condition: AUClast of PF- 06260414 formulations
时间窗: Hour 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose
Single dose pharmacokinetics under fasted condition: Cmax of PF- 06260414 formulations
时间窗: Hour 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose
Single dose pharmacokinetics under fed condition: Cmax of PF- 06260414 formulations
时间窗: Hour 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose
Single dose pharmacokinetics under fed condition: AUClast of PF- 06260414 formulations
时间窗: Hour 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose
次要结局
- AUCinf of PF-06260414(Hour 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose)
- t½ of PF-06260414(Hour 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose)
- Tmax of PF-06260414(Hour 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose)