A Phase 1, Open Label, Single-dose 3-way Crossover Study To Evaluate The Relative Bioavailability Of A Solid Dose Formulation Of Pf-06651600 Under Fasting Conditions And The Effect Of A High Fat Meal On The Bioavailability Of The Solid Dosage Formulation Of Pf-06651600 In Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-06651600
研究概览
简要总结
PF-06651600 is being developed for treatment of inflammatory bowel disease. This study will test the bioavailability of a solid dose formulation of PF-06651600 compared to an oral solution formulation under fasting conditions and the effect of a high fat meal on the bioavailability of the solid dose formulation of PF-06651600 in healthy subjects. Safety and tolerability of the tablet and oral solution formulations of PF-06651600 will be assessed under fasting and fed conditions.
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/female subjects between 18 and 55 years old, inclusive. Females must be of non-child bearing potential.
- •BMI of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
- •Prior history of chicken pox.
- •Evidence of personally signed and dated informed consent document.
- •Willing and able to comply with scheduled visits, treatment plan, lab tests and other study procedures.
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, GI, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
- •History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males.
- •Screening blood pressure >140/90 mm Hg.
- •Screening laboratory abnormalities as defined by the protocol.
- •Unwilling or unable to comply with the Lifestyle Guidelines as defined by the protocol.
研究组 & 干预措施
Cohort 1: PF-06651600
Single dose of PF-06651600 50 mg tablet (under fasted condition and following high fat meal) and 50 mg oral formulation (under fasted condition) to evaluate bioavailability.
干预措施: PF-06651600 (Drug)
Cohort 2: PF-06651600
Single dose of PF-06651600 50 mg tablet (under fasted condition and following high fat meal) and 50 mg oral formulation (under fasted condition) to evaluate bioavailability.
干预措施: PF-06651600 (Drug)
Cohort 3: PF-06651600
Single dose of PF-06651600 50 mg tablet (under fasted condition and following high fat meal) and 50 mg oral formulation (under fasted condition) to evaluate bioavailability.
干预措施: PF-06651600 (Drug)
Cohort 4: PF-06651600
Single dose of PF-06651600 50 mg tablet (under fasted condition and following high fat meal) and 50 mg oral formulation (under fasted condition) to evaluate bioavailability.
干预措施: PF-06651600 (Drug)
Cohort 5: PF-06651600
Single dose of PF-06651600 50 mg tablet (under fasted condition and following high fat meal) and 50 mg oral formulation (under fasted condition) to evaluate bioavailability.
干预措施: PF-06651600 (Drug)
Cohort 6: PF-06651600
Single dose of PF-06651600 50 mg tablet (under fasted condition and following high fat meal) and 50 mg oral formulation (under fasted condition) to evaluate bioavailability.
干预措施: PF-06651600 (Drug)
结局指标
主要结局
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-06651600
时间窗: 0, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06651600
时间窗: 0, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Time to Reach Maximum Observed Plasma Concentration (Cmax) for PF-06651600
时间窗: 0, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
Time to Reach Maximum Observed Plasma Concentration (Cmax)
次要结局
- Plasma Decay Half Life (t1/2) for PF-06651600(0, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose)
- Time to Reach Maximum Concentration (Tmax) for PF-06651600(0, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose)