A Randomized, Double-Blind, Placebo-Controlled, Double-Dummy, Multiple-Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Endpoints of MK0773 in Healthy Older Men
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 68
- 主要终点
- Number of subjects with Serious CAEs
研究概览
简要总结
This study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of MK0773 in healthy older men.
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
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Subject is in good general health
- •Subject agrees to avoid excess alcohol and strenuous physical activity during the study
- •Subject who is sexually active with partners of reproductive potential agrees to use two forms of appropriate contraception during the study
排除标准
- •Subject has significant drug allergies
- •Subject has donated blood within the last 8 weeks or has 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
- •Subject has a history of prostate or testicular surgery
研究组 & 干预措施
1
MK0773 + placebo injection
干预措施: MK0773 (Drug)
结局指标
主要结局
Number of subjects with Serious CAEs
时间窗: 12 weeks
Number of subjects with drug-related CAEs
时间窗: 12 weeks
Number of subjects with serious drug-related CAEs
时间窗: 12 weeks
Number of subjects with serious LAEs
时间窗: 12 weeks
Number of subjects with serious drug-related LAEs
时间窗: 12 weeks
Number of subjects that discontinued with LAEs
时间窗: 12 weeks
Number of subjects with Clinical Adverse Events (CAE)
时间窗: 12 weeks
Number of subjects that discontinued with CAEs
时间窗: 12 weeks
Number of subjects with Laboratory Adverse Events (LAE)
时间窗: 12 weeks
Number of subjects with drug-related LAEs
时间窗: 12 weeks
次要结局
未报告次要终点