NCT00990015已完成1 期
A Phase 1, Randomized, Double-Blind, Sponsor-Open, Placebo-Controlled, Single-Dose Escalation Trial Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-04308515 in Healthy Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- To evaluate the safety, tolerability and pharmacokinetics (PK) of single-rising doses of PF-04308515
研究概览
简要总结
The purpose of this study is to determine the safety, tolerability, pharmacokinetics (understanding how a drug is absorbed and moves through the body) and pharmacodynamics (understanding the effects of a drug on certain target sites of activity in the body).
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
- 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.
- •Women need 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 glucocorticoids
研究组 & 干预措施
PF-04308515
Experimental
干预措施: PF-04308515 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
To evaluate the safety, tolerability and pharmacokinetics (PK) of single-rising doses of PF-04308515
时间窗: 1 day
To characterize the pharmacodynamic (PD) effects of PF-04308515 on biomarkers
时间窗: 1 day
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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