NCT00619736已完成1 期
Ascending Single Dose Study of the Safety, Tolerability and Pharmacokinetics of NSA-789 Administered Orally to Healthy Japanese Male Subjects
Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点目标入组 56 人开始时间: 2008年3月最近更新:
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
- 入组人数
- 56
- 主要终点
- Safety and Tolerability
研究概览
简要总结
This study will provide an initial assessment of the safety, tolerability and pharmacokinetics (PK) of NSA-789 after administration of ascending single oral doses to healthy Japanese male subjects. This is a randomized, double-blind, placebo-controlled, inpatient, sequential-group study conducted under fasting conditions at a single investigational site. Each subject will participate in only 1 dose group and will receive only 1 dose of test article.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Men aged 20 to 45 years inclusive at screening.
- •Healthy as determined by the investigator on the basis of screening evaluations.
排除标准
- •Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
- •Use of any investigational drug within 90 days before study day 1 or prescription drug within 30 days before study day 1
- •Any clinically important deviation from normal limits in physical examination, vital signs, 12-lead electrocardiograms (ECGs), or clinical laboratory test results.
研究组 & 干预措施
NSA-789
Experimental
干预措施: NSA-789 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Other)
结局指标
主要结局
Safety and Tolerability
时间窗: 3 months
次要结局
- Pharmacokinetics(3 months)
研究者
相似试验
已完成
1 期
Study Evaluating the Safety, Tolerability and Activity of One Dose of PAZ-417 Given to Healthy Japanese SubjectsAlzheimer DiseaseHealthyNCT00684710Wyeth is now a wholly owned subsidiary of Pfizer56
已完成
1 期
Study Evaluating the Safety, Tolerability, and Pharmacokinetics (PK) of HKI-357 Administered Orally to Healthy SubjectsHealthyNCT00550381Wyeth is now a wholly owned subsidiary of Pfizer72
终止
1 期
Study Evaluating FXR-450 in Healthy Japanese MenHealthyNCT00509756Wyeth is now a wholly owned subsidiary of Pfizer56
已完成
1 期
Study Evaluating the Safety and Pharmacokinetics of Ascending Single IV Doses of ERB-257Healthy SubjectsNCT00722501Wyeth is now a wholly owned subsidiary of Pfizer48
已完成
1 期
Safety, Tolerability, Pharmacokinetics (Including Food Interaction), and Pharmacodynamics of BIA 3-202Parkinson's DiseaseNCT02763787Bial - Portela C S.A.71