A Phase I, Randomized, Placebo-Controlled, Dose Escalating Cross Over Study To Evaluate The Safety, Toleration, Pharmacokinetics And Pharmacodynamics Of PF-05105679 Under Fasted Conditions In Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Number of participants with adverse events as a measure of safety and tolerability.
研究概览
简要总结
This is a two part study. The purpose of the first part (Part A) is the evaluation of the pharmacokinetics, safety and tolerability after single ascending dose of PF-05105679. The second part (Part B) of this study will focus on the exploratory pharmacodynamics of PF-05105679 using pharmacodynamics markers (cold detection) in healthy volunteers. The doses selected in Part B will have been administered previously in the Part A of the study.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy Volunteers
排除标准
- •Standard Healthy Volunteers
研究组 & 干预措施
Cohort 1: Experimental intervention: PF-05105679 or placebo
Cohort 1
干预措施: PF-05105679 (Drug)
Cohort 2: Experimental intervention: PF-05105679 or placebo
Cohort 2
干预措施: PF-05105679 (Drug)
Cohort 3: Experimental intervention PF-05105679 or placebo and
Cohort 3
干预措施: PF-05105679 (Drug)
结局指标
主要结局
Number of participants with adverse events as a measure of safety and tolerability.
时间窗: 3 days
Pharmacokinetics of single doses of PF-05105679 as measured by plasma concentrations- Cmax, Tmax, half life, AUC last, AUC(0-24) and MRT
时间窗: 3 days
次要结局
- Average AUC2min VAS (cold pressor test) of PF-05105679.(24 hours)
- Cold detection threshold (°C) of PF-05105679.(24 hours)
- Cold pain threshold (°C) of PF-05105679.(24 hours)
- Stimulus-response function to cold stimuli following menthol application.(24 hours)