NCT00150215已完成1 期
An Oral, Rising Single-Dose Tolerance, Pharmacokinetic, and Pharmacodynamic Study of Pf-00184562 Capsules In Healthy Volunteers
适应症
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
- 18
- 试验地点
- 2
- 主要终点
- Safety and tolerability of single dose PF-00184562 as determined by: adverse event reporting, clinical laboratory results, vital signs, physical examinations, and electrocardiograms (ECGs).
研究概览
简要总结
The purposes of this study are:
- To determine the safety, tolerability and pharmacokinetics of single doses of PF-00184562; and
- To explore the exposure-response relationship of neuropsychometric and tolerability measures of PF-00184562 compared to olanzapine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double
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 male or female subjects of non-childbearing potential
排除标准
- •Subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, pancreatic, psychiatric, neurologic, active infections, immunological, or allergic disease (including drug allergies and seasonal allergies at time of dosing).
结局指标
主要结局
Safety and tolerability of single dose PF-00184562 as determined by: adverse event reporting, clinical laboratory results, vital signs, physical examinations, and electrocardiograms (ECGs).
Pharmacokinetic profile of PF-00184562 maximum concentration (Cmax)
Time to obtain maximum concentration (tmax), area under concentration-time curve (AUC), and terminal half-life (t1/2).
Exposure-response relationship of neuropsychometric and tolerability measures of PF-00184562 compared to olanzapine.
All measurements to be assessed over single doses.
次要结局
未报告次要终点
研究者
研究点 (2)
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