NCT00444704已完成1 期
Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PRA-027 Administered Orally to Healthy Japanese Females
Wyeth is now a wholly owned subsidiary of Pfizer1 个研究点 分布在 1 个国家开始时间: 2007年3月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 试验地点
- 1
- 主要终点
- The primary outcome of this study is to asess the safety and tolerability of ascending single oral doses of PRA-027 in healthy Japanese females.
研究概览
简要总结
The primary purpose of this study is to assess the safety and tolerability of ascending single oral doses of PRA-027 in healthy Japanese females. The secondary purpose is to provide the initial pharmacokinetic and pharmacodynamic profiles of PRA-027 in healthy Japanese female subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 20 Years 至 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women of nonchildbearing potential aged 20 to 64 years. Must have a negative pregnancy test result within 48 hours before administration of test article. Women who are surgically sterile must provide documentation of the procedure by an operative report or by ultrasound scan.
- •Body mass index (BMI) in the range of 17.6 to 26.4 kg/m2 and body weight must be at least 45 kg.
- •Healthy as determined by the investigator on the basis of screening evaluation.
排除标准
- •Any significant cardiovascular, hepatic, renal, respiratory, gynecologic gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
- •Any history of drug abuse or admitted alcohol abuse or history of alcohol use that may interfere with the subject's ability to comply with the protocol requirements.
- •Use of any investigational drug within 90 days before study day 1, use of any prescription drug within 30 days before study day 1, consumption of any caffeine-containing products (eg, coffee, tea, chocolate, or cola) or alcoholic beverages within 48 hours before study day 1, consumption of grapefruit or grapefruit-containing products within 72 hours before study day 1, use of any over-the-counter drugs, including herbal supplements (except for the occasional use of vitamins ≤100% of the recommended daily allowance), within 14 days before study day 1, or the donation of blood within 90 days before study day 1.
结局指标
主要结局
The primary outcome of this study is to asess the safety and tolerability of ascending single oral doses of PRA-027 in healthy Japanese females.
次要结局
未报告次要终点
研究者
研究点 (1)
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