NCT00770159已完成1 期
A Double-Blind, Placebo-Controlled, Once-Weekly, Multiple-Dose Study to Investigate the Safety, Tolerability, Plasma Concentration Profile and Effects on Biochemical Markers of Bone Resorption of MK0822 in Healthy 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
- 78
- 主要终点
- Number of Participants With One or More Adverse Events
研究概览
简要总结
This study will assess the safety, tolerability, PK, and PD of a once weekly dose of MK0822 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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Subject is less than or equal to 75 years of age
- •Subject is a postmenopausal female
- •Subject is within 30% of ideal body weight
- •Subject is judged to be in good health
- •Subject is a nonsmoker
- •Subject is willing to avoid excessive alcohol consumption for the duration of the study
- •Subject is willing to avoid strenuous physical activity for the duration of the study
- •Subject agrees to refrain from consuming grapefruit or grapefruit juice for the duration of the study
排除标准
- •Subject has a history of multiple/severe allergies to foods or drugs
- •Subject has had surgery within 12 weeks of starting study or has given blood within 4 weeks of starting study
- •Subject has a history of major GI abnormalities/ulcers, or genitourinary, cardiovascular, hepatic, pulmonary, psychiatric, endocrine, or metabolic diseases
- •Subject has a history of bone disease or treatment with bisphosphonates
- •Subject has an infection/condition that would suppress the immune system, including HIV
- •Subject has a history of chronic/active hepatic (liver) disease, including Hepatitis B and C
- •Subject regularly uses illegal drugs
- •Subject consumes more than 3 alcoholic beverages per day
- •Subject consumes more than 4 cups of brewed coffee (or equivalent caffeinated beverages) per day
- •Subject requires use of any prescription or non-prescription medications during the study
- •Part I only: subject has received treatment with any of the following: any estrogen preparation, anabolic steroids, calcitonin, or progestins within 6 months of study start; thyroid hormone if not on a stable dose; fluoride treatment greater than 1mg/day for more than 2 weeks; Glucocorticoid treatment; Vitamin A greater than 10,000 U/day, vitamin D greater than 2000 U/day, anticonvulsants; selective estrogen receptor modulators within 6 months of study start; parathyroid hormone within 2 years of study start; or bisphosphonates.
研究组 & 干预措施
1
Experimental
MK0822
干预措施: odanacatib (Drug)
结局指标
主要结局
Number of Participants With One or More Adverse Events
时间窗: Up to 7 weeks
Number of Participants Who Discontinued Study Drug Due to Adverse Events
时间窗: Up to 6 weeks
次要结局
- Area Under Time Curve From 0 to 24 Hours (AUC 0-24hr) at Week 1 and Week 3(Up to 24 hours postdose, Week 1 and Week 3)
研究者
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