A Phase 1, Placebo-Controlled, Multiple-Dose Escalation Trial Evaluating The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of PF-04308515 (Part 1), And A Single Dose Pharmacokinetic Assessment Of A PF-04308515 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
- 58
- 试验地点
- 1
- 主要终点
- Change from baseline will be utilized to assess PF-04308515's pharmacodynamic effect on biochemical and metabolic biomarkers after 14 days of dosing.
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-04308515 in healthy volunteers for 14 days as well as one oral dose of a tablet formulation administered for 1 day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- •Females are required to be surgically sterile
排除标准
- •Evidence or history of clinically significant disease
- •Post-menopausal women
- •History of intolerance or significant adverse effects with glucocorticoid therapy
研究组 & 干预措施
(Part 1) PF-04308515
干预措施: PF-04308515 (Drug)
(Part 1) Solution Placebo
干预措施: Placebo (Drug)
(Part 2) PF-04308515 Tablet
干预措施: PF-04308515 Tablet (Drug)
结局指标
主要结局
Change from baseline will be utilized to assess PF-04308515's pharmacodynamic effect on biochemical and metabolic biomarkers after 14 days of dosing.
时间窗: 14 days
Characterization of pharmacokinetic parameters of PF-04308515 after multiples doses which will include: Cmax, Tmax, AUC, CL/F, Vz/F, t1/2. Urinary excretion including AE% and CLr will be assessed at steady state.
时间窗: 14 days
Safety and tolerability of 1 oral dose of a tablet formulation of PF-04308515 as assessed by adverse event reporting, clinical laboratory results, vital signs, physical examinations and electrocardiograms (ECGs).
时间窗: 1 day
Safety and tolerability of multiple doses of PF-04308515 as assessed by adverse event reporting, clinical laboratory results, vital signs, physical examinations and electrocardiograms (ECGs).
时间窗: 14 days
For the tablet pharmacokinetics:Cmax, Tmax, AUClast, AUCinf, CL/F, Vz/F, t1/2 will be calculated from the PF-04308515 plasma concentration versus time data.
时间窗: 1 day
次要结局
未报告次要终点