An Open-Label, Non-Randomized, Pharmacokinetic and Safety Study of Multiple Oral Doses of GW679769 in Subjects With Renal Impairment
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Area under the plasma drug concentration versus time curve from 0 to 24 hours (AUC[0-24]) of casopitant and GSK525060
研究概览
简要总结
The purpose of the study is to evaluate how subjects with mild or moderate kidney problems process or breakdown the study drug GW679769 in their bodies as compared to healthy subjects.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Subjects receiving casopitant
Eligible subjects will receive a 100 milligrams oral dose of casopitant once daily for five consecutive days.
干预措施: Casopitant (Drug)
结局指标
主要结局
Area under the plasma drug concentration versus time curve from 0 to 24 hours (AUC[0-24]) of casopitant and GSK525060
时间窗: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 and 16 hours on Day 1; pre-dose on Day 2, Day 3 and Day 4; Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours on Day 5
Blood samples will be collected at the indicated time points for pharmacokinetic analysis.
Maximum observed concentration (Cmax) of casopitant and GSK525060
时间窗: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 and 16 hours on Day 1; pre-dose on Day 2, Day 3 and Day 4; Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours on Day 5
Blood samples will be collected at the indicated time points for pharmacokinetic analysis.
次要结局
- Number of subjects having abnormal values for urinalysis as a measure of safety(Up to Day 22)
- Number of subjects with abnormal findings after serological tests(Up to Day 22)
- Half-life of casopitant and GSK525060(Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 and 16 hours on Day 1; pre-dose on Day 2, Day 3 and Day 4; Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours on Day 5)
- Time to maximum observed plasma drug concentration (Tmax) of casopitant and GSK525060(Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 and 16 hours on Day 1; pre-dose on Day 2, Day 3 and Day 4; Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours on Day 5)
- Free fraction (percent unbound) of casopitant and GSK525060(1,2,4 and 24 hours post-dose on Day 1; pre-dose,1,2,4 and 24 hours post-dose on Day 5)
- Number of subjects with adverse events (AEs) and serious adverse events (SAEs)(Up to Day 22)
- Number of subjects with abnormal values for blood pressure(Up to Day 22)
- Number of subjects with abnormal values for heart rate(Up to Day 22)
- Number of subjects with abnormal findings after weight measurement(Up to Day 22)
- Number of subjects having abnormal hematology laboratory parameters as a measure of safety(Up to Day 22)
- Number of subjects having abnormal clinical Chemistry laboratory parameters as a measure of safety(Up to Day 22)