NCT00427544已完成1 期
Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PRA-027 Administered Orally to Healthy Women of Nonchildbearing Potential
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2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 women of nonchildbearing potential.
研究概览
简要总结
The primary purpose of this study is to asess the safety and tolerability of ascending single oral doses of PRA-027 in healthy women of nonchildbearing potential. The secondary purpose is to provide the initial pharmacokinetic (PK) and pharmacodynamic (PD) profile of PRA-027 in healthy women of nonchildbearing potential, and to evaluate the effect of a high-fat meal on the PK and PD of PRA-027 administered to healthy women of nonchildbearing potential.
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
- Single
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women of nonchildbearing potential (WONCBP) aged 18 to 60 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 ultrasound scan.
- •Body mass index (BMI) in the range of 18.0 to 30.0 kg/m2 and body weight ³50 kg. BMI is calculated by taking the subject's weight, in kilograms, divided by the square of the subject's height, in meters, at screening: BMI=weight (kg)/[height (m)]2
- •Healthy as determined by the investigator on the basis of screening evaluations.
排除标准
- •Any significant cardiovascular, hepatic, renal, respiratory, gynecologic, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
- •A history of drug abuse within 1 year before study day 1, a history of alcoholism within 1 year before study day 1 or consumption of more than 2 standard units of alcohol per day (a standard unit equals 12 ounces of beer, 1½ ounces of 80-proof alcohol, or 6 ounces of wine). Any positive findings during the urine drug screen for amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, and opiates.
- •Use of any investigational or prescription drug within 30 days before test article administration. Consumption of any caffeine-containing products (eg, coffee, tea, chocolate, or soda) or alcoholic beverages within 48 hours before study day
- •Consumption of grapefruit or grapefruit-containing products within 72 hours before study day
- •Use of any over-the-counter drugs, including herbal supplements (except for the occasional use of acetaminophen and vitamins ≤100% of the recommended daily allowance) within 14 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 women of nonchildbearing potential.
次要结局
未报告次要终点
研究者
研究点 (1)
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