A Phase 1, Active and Placebo-Controlled, Multiple-Dose Escalation Trial Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-04171327 (Part 1), and a Single Dose Pharmacokinetic Assessment of a Tablet Formulation (Part 2) in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Safety and tolerability of multiple doses of PF-04171327
研究概览
简要总结
The purpose of this study is to determine the safety, tolerability, pharmacokinetics and pharmacodynamics (how the drug effects certain target sites of activity in the body) of escalating doses of oral PF-04171327 in healthy volunteers for 14 days (Part 1). Part 2 will evaluate the pharmacokinetics of a single 10 mg dose of the PF-04171327 tablet in healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
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 males between 18 and 55 years, inclusive.
- •Healthy females between 18 and 44 years, inclusive.
排除标准
- •Evidence or history of clinically significant disease;
- •Post-menopausal women;
- •History of intolerance or significant adverse effects with glucocorticoids. therapy.
研究组 & 干预措施
PF-04173127
干预措施: PF-04171327 (Drug)
Prednisolone
干预措施: Prednisolone (Drug)
Placebo
干预措施: Placebo (Drug)
Solution Placebo
干预措施: Placebo Solution (Drug)
PF-04171327 Tablet
干预措施: PF-04171327 Tablet (Drug)
结局指标
主要结局
Safety and tolerability of multiple doses of PF-04171327
时间窗: 14 days
Determination of pharmacokinetic parameters of PF-04171327 after multiple doses
时间窗: 14 days
Assessment of the pharmacodynamic effects of PF-04171327 on chemical and metabolic biomarkers
时间窗: 14 days
Evaluation of the pharmacokinetic parameters of a single 10 mg dose of PF-04171327 tablet
时间窗: 1 day
次要结局
- To characterize the pharmacodynamic effects of prednisolone(14 days)