NCT01122667已完成1 期
A Single-Dose Study to Investigate the Pharmacokinetics of MK0859 in Subjects With Impaired Renal Function
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
- Area Under the Curve (AUC(0 to infinity)) of anacetrapib
研究概览
简要总结
This study will evaluate the Area Under the Curve (AUC(0 to infinity)) of anacetrapib in subjects with impaired renal function and healthy matched control subjects.
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
- None
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
- •Female subjects of reproductive potential test negative for pregnancy and agree to use two acceptable methods of birth control throughout the study
- •Subject is in good health
- •If Subject is a smoker, smoking is limited to no more than 10 cigarettes per day
排除标准
- •Subject has a history of stroke, chronic seizures or major neurological disorder
- •Subject has a history of cancer
- •Subject is unable to refrain from or anticipates the use of any prescription or non-prescription medication during the study
- •Subject consumes excessive amounts of alcohol or caffeine
- •Subject has had major surgery, donated blood or participated in another investigational study within the past 4 weeks
- •Subject is a nursing mother
- •Subject has had a kidney removed or has a functioning renal transplant
研究组 & 干预措施
Part 1 - Panel A
Experimental
Subjects with severe renal impairment
干预措施: anacetrapib (Drug)
Part 1 - Panel B
Experimental
Healthy matched control subjects
干预措施: anacetrapib (Drug)
Part 2 - Panel C
Experimental
Subjects with moderate renal impairment
干预措施: anacetrapib (Drug)
Part 2 - Panel D
Experimental
Healthy matched control subjects
干预措施: anacetrapib (Drug)
Part 2 - Panel E
Experimental
Subjects with mild renal impairment
干预措施: anacetrapib (Drug)
Part 2 - Panel F
Experimental
Healthy matched control subjects
干预措施: anacetrapib (Drug)
结局指标
主要结局
Area Under the Curve (AUC(0 to infinity)) of anacetrapib
时间窗: through 168 hours post dose
次要结局
- Safety and tolerability of a single dose administration of 100mg anacetrapib, measured by the number of clinical and laboratory adverse events(through 14 days post dose)
研究者
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