A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Efficacy of MK0773 in Healthy Postmenopausal Women
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 67
- 主要终点
- Number of Participants with Serious Clinical Adverse Events
研究概览
简要总结
This study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamic efficacy of MK0773 in healthy postmenopausal women.
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 (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
- •Subject is a nonsurgical postmenopausal female
- •Subject is neither grossly overweight nor underweight for her height
- •Subject is in good health
- •Subject is willing to avoid excess alcohol and strenuous physical activity during the study
- •Subject agrees to refrain from consuming St. John's Wort, grapefruit or grapefruit juice during the study
排除标准
- •Subject has significant drug allergies
- •Subject has donated blood or taken an investigational drug in another clinical trial within the last 4 weeks
- •Subject is a regular user or past abuser of any illicit drug (including alcohol)
- •Subject drinks excessive amounts of caffeinated beverages
- •Subject has a history of cancer
研究组 & 干预措施
Postmenopausal Women- Active Agent Group
干预措施: MK 0773 (Drug)
Postmenopausal Women- Placebo
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants with Serious Clinical Adverse Events
时间窗: From date of enrollment through 12 weeks of study
Number of Participants with Nonerserious Clinical Adverse Events
时间窗: From date of enrollment through 12 weeks of study
Number of Participants with Serious Laboratory Adverse Events
时间窗: From date of enrollment through 12 weeks of study
Number of Participants with Nonserious Laboratory Adverse Events
时间窗: From date of enrollment through 12 weeks of study
Number of Participants Who Discontinued Due to Any Adverse Event
时间窗: From date of enrollment through 12 weeks of study
Number of Participants Who Withdrew Consent and Discontinued the Study
时间窗: From date of enrollment through 12 weeks of study
Least Squares Mean Change in Lean Body Mass
时间窗: From baseline, at 12 weeks
次要结局
未报告次要终点