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临床试验/NCT00373243
NCT00373243已完成1 期

An Open-label, Non-randomised Study of 20 mg GW406381 Single Dose Pharmacokinetics in Healthy Subjects and in Volunteers With Moderate Hepatic Impairment

GlaxoSmithKline1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2005年10月19日最近更新:
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
试验地点
1
主要终点
GW406381 pharmacokinetic parameters AUC and Cmax

研究概览

简要总结

This study will assess the pharmacokinetics and tolerability of a single dose of GW406381 in subjects with moderate hepatic impairment in comparison to matched healthy volunteers. The hepatically impaired and healthy groups will be given a single 20 mg oral dose of GW406381. Blood samples for PK analysis will be collected pre-dose and over the 72 hours post dosing. Subjects will be housed from the evening before dosing until 24 hours after dosing. A follow-up visit will be conducted between 7 to 10 days from the last dose of study drug.

研究设计

研究类型
Interventional
分配方式
Non 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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Subjects receiving GW406381

Experimental

Subjects will receive single oral dose of 20 milligram (mg) of GW406381.

干预措施: GW406381 (Drug)

结局指标

主要结局

GW406381 pharmacokinetic parameters AUC and Cmax

时间窗: throughout the study

次要结局

  • GW406381 pharmacokinetic parameters Tmax, Total plasma clearance, and if data permits the t1/2 of GW406381 GW404347 pharmacokinetic parameters AUC and Cmax Ex vivo protein binding Clinical laboratory values, adverse events, vital signs and 12 lead ECG(throughout the study)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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