NCT00769418已完成1 期
A Double-Blind, Randomized, Placebo-Controlled, Multi-Panel, Multiple Oral Dose Study, to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK0822 in Healthy Male and Postmenopausal Female Subjects
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
- 62
- 主要终点
- Safety and tolerability of multiple oral doses of MK0822
研究概览
简要总结
This study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of once-daily multiple-dose administration of odanacatib (MK0822).
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is a male between the ages of 18 and 45 or a female less than or equal to 70 years of age
- •Females must be past menopause
- •Subject is a nonsmoker
- •Subject is willing to avoid excessive alcohol consumption during the study and is willing to avoid alcohol entirely for 24 hours prior to drug administration and during PK sampling
- •Subject is willing to refrain from consuming grapefruit or grapefruit juice
排除标准
- •Subject has a history of multiple/severe allergies to drugs or food
- •Subject has donated blood within 4 weeks of starting the study
- •Subject has a history of metabolic bone disease, urolithiasis, or bisphosphonate treatment
- •Subject has any infections or any condition leading to immune problems, including HIV
- •Subject regularly uses illegal drugs
- •Subject consumes more than 3 alcoholic beverages per day
- •Subject drinks 4 or more caffeinated beverages per day
- •Subject uses any prescription or nonprescription medications
研究组 & 干预措施
1
Experimental
odanacatib (MK0822)
干预措施: odanacatib (Drug)
结局指标
主要结局
Safety and tolerability of multiple oral doses of MK0822
时间窗: After 14 days of treatment for men and 21 days for women
次要结局
- PK profile of MK0822(predose and at selected time intervals postdose)
研究者
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