NCT00543790已完成1 期
A Randomized, Placebo-Controlled, Double-Blind, Sponsor-Unblinded, Multiple-Dose Study Of The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of PRA-027 Administered Orally To Cycling Or Postmenopausal Women
Wyeth is now a wholly owned subsidiary of Pfizer1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2007年11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
- 48
- 试验地点
- 1
- 主要终点
- To assess the safety and tolerability of ascending, multiple, oral doses of PRA-027 in cycling and postmenopausal women.
研究概览
简要总结
This is the first multiple-dose study in humans with PRA-027. This study will provide an assessment of the safety, tolerability, pharmacokinetics (how the drug is absorbed, metabolized and excreted by the body) and pharmacodynamics (a measure of whether the drug is active in the body) of PRA-027 after administration of 28 days of oral doses in women of childbearing potential (cycling) or postmenopausal women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Inclusion Criteria - All Women
- •Healthy, nonsmoker or smoker of fewer than 10 cigarettes (half a pack) per day and able to abstain from tobacco throughout all times when in the clinical facility.
- •Inclusion Criteria - Cycling Women
- •Aged 18 to 45 years, must not be breastfeeding, pregnant, or have a recent (within 90 days before pretreatment period day 1) history of pregnancy, with a history of regular menstrual cycles (21 to 35 days in duration).
- •Inclusion Criteria - Postmenopausal Women
- •Aged 35 to 65 years, menopause may be natural or due to surgery, natural amenorrhea must have begun by age of 55 years and have initiated at least 6 months before study day 1.
排除标准
- •Women with hysterectomy or complex or simple ovarian cysts greater than 3 cm in diameter.
- •History of drug abuse (within 6 months) or alcoholism (within 12 months).
- •History of female infertility.
研究组 & 干预措施
1
Experimental
干预措施: PRA-027 (Drug)
结局指标
主要结局
To assess the safety and tolerability of ascending, multiple, oral doses of PRA-027 in cycling and postmenopausal women.
时间窗: 28 days
次要结局
- To provide the PK and PD profile of multiple oral doses of PRA-027 in cycling and postmenopausal women.(28 days)
研究者
研究点 (1)
Loading locations...
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