An Open-Label, Single Dose Study to Investigate the Influence of Hepatic Insufficiency on the Pharmacokinetics of MK0431

Merck Sharp & Dohme LLC0 个研究点目标入组 20 人开始时间: 2004年4月最近更新: 2015年8月19日

适应症

试验速览

阶段: 1 期
状态: 已完成
发起方: Merck Sharp & Dohme LLC
入组人数: 20
主要终点: the plasma and urine pharmacokinetic parameters of MK0431

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

A study to compare the plasma concentrations of MK0431 at different times in patients with hepatic insufficiency vs healthy 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 75 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•If female, non pregnant, BMI less than 40 kg/m2
•Patient has chronic, stable hepatic insufficiency

排除标准

•Patient unwilling to refrain from alcohol and grapefruit juice prior to and shortly after study drug administration
•Patient has diabetes, had a heart attack or stroke, or uncontrolled congestive heart failure during the past 6 months
•Patient has a history of drug or alcohol abuse
•Patient smokes > 10 cigarettes per day
•Patient consumes more that 6 cups of caffeinated beverages per day
•Patient has had surgery, donated blood or participated in another clinical trial within the past 4 weeks

结局指标

主要结局

the plasma and urine pharmacokinetic parameters of MK0431

时间窗: measured at predose, 0.5, 1,1.5, 2, 3, 4, 5, 6, 8, 10, 12, 15, 18, 24, 32, 48, 72 and 96 hours post dose

次要结局

Side effects, physical exam, lab safety data, urging drug screen, ECG and vital signs(throughout study and at 12 weeks)

研究者

发起方

Merck Sharp & Dohme LLC

申办方类型

Industry

责任方

Sponsor

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