NCT01114490已完成1 期
A Single Dose Study to Investigate the Pharmacokinetics of MK0859 in Patients With Hepatic Insufficiency
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.
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
- •Subject agrees to refrain from consumption of red wine, grapefruit, orange and apple juices throughout the study
排除标准
- •Patient has a history of cancer
- •Patient is a nursing mother
- •Patient is unable to refrain from or anticipates the use of any prescription or non-prescription medication during the study
- •Patient consumes excessive amounts of alcohol or caffeine
- •Patient has had major surgery, donated blood or participated in another investigational study within the past 4 weeks
研究组 & 干预措施
Part 2 - Group 1
Experimental
Mild Hepatic Patients
干预措施: anacetrapib (Drug)
Part 1 - Group 1
Experimental
Moderate Hepatic Patients
干预措施: anacetrapib (Drug)
Part 1 - Group 2
Experimental
Healthy Subjects
干预措施: anacetrapib (Drug)
Part 2 - Group 2
Experimental
Healthy 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
- 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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