NCT00547560已完成1 期
An Ascending Multiple Dose Study Of The Safety, Pharmacokinetics, And Pharmacodynamics Of GSI-953 Administered Orally To Healthy Elderly Subjects
Wyeth is now a wholly owned subsidiary of Pfizer1 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2007年8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
- 49
- 试验地点
- 1
- 主要终点
- The pharmacokinetic and pharmacodynamic profile for the elderly subjects.
研究概览
简要总结
To assess the safety and tolerability of ascending, multiple, oral doses of GSI-953 in healthy elderly subjects.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men or women, greater than or equal to 65 years of age.
- •Women of nonchildbearing potential (WONCP) may be included if they are either surgically sterile (hysterectomy and/or oophorectomy) or postmenopausal for greater than or equal to 1 year (with FSH greater than or equal to 38 mIU/mL) and 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.
- •Body mass index (BMI) in the range of 18.0 to 30.0 kg/m2 and body weight >50 kg.
排除标准
- 未提供
研究组 & 干预措施
GSI+Placebo
Other
干预措施: GSI-953 (Drug)
结局指标
主要结局
The pharmacokinetic and pharmacodynamic profile for the elderly subjects.
时间窗: 6 months
次要结局
- Pharmacokinetics (PK)(6 months)
- Pharmacodynamics (PD)(6 months)
研究者
研究点 (1)
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