A Phase 1, Single-Dose, Open-Label, Crossover Study To Assess The Relative Bioavailability Of Powder-In-Capsule And A Tablet Formulation Of Pf-05175157 And The Effect Of Food On The Pharmacokinetics Of The Tablet Formulation In Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Maximum Observed Plasma Concentration (Cmax)
研究概览
简要总结
The purpose of this study in healthy volunteers is to assess the relative bioavailability of PF-05175157 as powder-in-capsule and a tablet formulation and the effect of food on the pharmacokinetics of the tablet formulation.
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 between the ages of 18 and 55 years, inclusive
- •Women must be of non childbearing potential
- •Body Mass Index (BMI) of 25 to 35 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 (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at Screening.
- •Active ocular disease including infection, glaucoma, seasonal allergies, dry eye symptoms, optic nerve disease or retinal disease.
- •History of habitual smoking in the past 5 years or history or evidence of habitual use of other (non smoked) tobacco or nicotine-containing products within 3 months of Screening or positive cotinine test at Screening or Day 0
研究组 & 干预措施
PF-05175157 tablet in fed state (repeat)
200 mg single dose of PF-05175157 administered as tablet formulation in the fed state (following a standard high fat meal).
干预措施: PF-05175157 (Drug)
PF-05175157 tablet in fed state
200 mg single dose of PF-05175157 administered as tablet formulation in the fed state (following a standard high fat meal).
干预措施: PF-05175157 (Drug)
PF-05175157 PIC in fed state
200 mg single dose of PF-05175157 administered as PIC in the fed state (following a standard high fat meal).
干预措施: PF-05175157 (Drug)
PF-05175157 tablet in fasted state
200 mg single dose of PF-05175157 administered as tablet formulation in the fasted state (following at least a 10 hour fast).
干预措施: PF-05175157 (Drug)
结局指标
主要结局
Maximum Observed Plasma Concentration (Cmax)
时间窗: 0 to 72 H after dose
Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf)
时间窗: 0 to 72 H after dose
次要结局
- Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)(0 to 72 H after dose)
- Time at which maximum plasma concentration is observed (Tmax)(0 to 72 H after dose)
- Plasma Decay Half-Life (t1/2)(0 to 72 H after dose)