A Phase 1, 2-part Study Of Pf-05221304 In Healthy Japanese Adults: Part 1 - Randomized, Double-blind, Crossover, Single Dose Assessment Of Pharmacokinetics And Safety; Part 2- Randomized, Double-blind, Placebo-controlled, Multiple Dose Assessment Of Safety, Tolerability And Pharmacokinetics Of Pf-05221304
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Cohort A: Area under the plasma concentration time profile from time zero to the time of the last quantifiable concentration (AUClast)
研究概览
简要总结
The current study is designed to evaluate the safety, tolerability and pharmacokinetics of PF-05221304 in healthy Japanese adult subjects following single and multiple dose administration.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female subjects who, at the time of screening, are between the ages of 20 and 55 years, inclusive.
- •Body mass index (BMI) of 17.5-30.5 kg/m2 inclusive; and a total body weight >50 kg (110 lb).
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing) or clinical findings at Screening.
研究组 & 干预措施
Cohort A_Active
3 single doses treatment of PF-05221304
干预措施: PF-05221304 (Drug)
Cohort B_Active
Repeated doses of PF-05221304
干预措施: PF-05221304 (Drug)
Cohort B_Placebo
Repeated doses of placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Cohort A: Area under the plasma concentration time profile from time zero to the time of the last quantifiable concentration (AUClast)
时间窗: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post dose
Cohort A: Maximum observed plasma concentration (Cmax)
时间窗: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post dose
Cohort A: Time to reach Cmax (Tmax)
时间窗: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post dose
Cohort A: Area under the plasma concentration time profile from time zero extrapolated to infinite time (as data permit) (AUCinf)
时间窗: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post dose
Cohort A: Terminal half life (as data permit) (t1/2)
时间窗: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post dose
Cohort A: Apparent clearance (as data permit) (CL/F)
时间窗: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post dose
Cohort A: Apparent volume of distribution (as data permit) (Vz/F)
时间窗: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, 48 and 72 hours post dose
Cohort B: Number of Subjects experiencing an Adverse Event
时间窗: Screening up to 28 days after last dose of study medication
Assessment of adverse events (AEs), clinical laboratory tests, vital signs (including blood pressure and pulse rate) and 12 lead ECG.
次要结局
- Cohort A: Number of Subjects experiencing an Adverse Event(Screening up to 28 days after last dose of study medication)
- Cohort B: Area under the plasma concentration time profile from time zero to time τ (tau), the dosing interval (ACUtau)(Day 1)(0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 hours post dose)
- Cohort B: Area under the plasma concentration time profile from time zero to time τ (tau), the dosing interval (ACUtau)(Day 14)(0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose)
- Cohort B: Maximum plasma concentration during the dosing interval (Cmax)(Day 1)(0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 hours post dose)
- Cohort B: Maximum plasma concentration during the dosing interval (Cmax)(Day 14)(0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose)
- Cohort B: Time to reach Cmax (Tmax)(Day 1)(0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 hours post dose)
- Cohort B: Time to reach Cmax (Tmax)(Day 14)(0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose)
- Cohort B: Minimum plasma concentration during the dosing interval (Cmin)(Day 14)(0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose)
- Cohort B: Peak trough ratio (PTR)(Day 14)(0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose)
- Cohort B: Observed accumulation ratio (Rac)(Day 14)(0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose)
- Cohort B: Observed accumulation ratio for Cmax (Rac,Cmax)(Day 14)(0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose)
- Cohort B: Terminal half life (t1/2)(Day 14)(0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose)
- Cohort B: Apparent volume of distribution (Vz/F)(Day 14)(0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose)
- Cohort B: Apparent clearance (CL/F)(Day 14)(0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post dose)