NCT00863590已完成1 期
A Double-Blind, Randomized, Placebo-Controlled, Multi-Panel, Single Oral Rising-Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of MK0822 in Healthy Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 主要终点
- safety and tolerability based on assessment of clinical and laboratory adverse experiences
研究概览
简要总结
This study assessed the safety, tolerability, and pharmacokinetics of single-dose odanacatib (MK0822) with and without food.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is in good health
- •Subject is a male between the ages of 18 and 45 years or (for Part I only) a female 60 years or younger
- •Female subject is postmenopausal
- •Subject is within 20% of ideal body weight
- •Subject is a nonsmoker
排除标准
- •Subject has multiple or severe allergies to food or medications
- •Subject has a history of metabolic bone disease, kidney/bladder stones, or treatment with bisphosphonates
- •Subject has any infections, including HIV
- •Subject consumes excessive amounts of caffeine or alcohol
- •Subject has donated blood or taken another investigational drug in the last month
- •Subject has a history of any illness that may confound the results of the study or pose additional risk in administering the study drug
研究组 & 干预措施
A
Experimental
Panel A
干预措施: odanacatib (Drug)
结局指标
主要结局
safety and tolerability based on assessment of clinical and laboratory adverse experiences
时间窗: Part I: 12 Weeks, Part II: 13 Weeks
次要结局
- Plasma concentration of MK0822(Up to 336 hours postdose)
研究者
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