NCT00359463已完成1 期
An Open-Label, Non-Randomized Pharmacokinetic and Safety Study of a Single Oral Dose of 50mg Eltrombopag in Healthy Subjects and in Volunteers With Mild, Moderate or Severe Hepatic Impairment
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
- 33
- 试验地点
- 1
- 主要终点
- Plasma levels and protein binding of eltrombopag
研究概览
简要总结
The main purpose of this study is to compare how one 50mg tablet of SB-497115 is broken down in the body by healthy subjects versus subjects with mild, moderate or severe liver problems. The study is also being done to 1) check on how well the study drug is tolerated by healthy subjects versus those with liver problems and 2) to check if liver impairment affects how the study drug binds to protein in the blood.
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
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Healthy subjects
Active Comparator
Subjects will receive a single 50 mg oral dose of eltrombopag.
干预措施: eltrombopag (Drug)
Subjects with hepatic impairment
Experimental
Subjects with mild, moderate or severe hepatic impairment will receive a single 50 mg oral dose of eltrombopag.
干预措施: eltrombopag (Drug)
结局指标
主要结局
Plasma levels and protein binding of eltrombopag
时间窗: Day 1 to Day 6
次要结局
- Safety will be monitored by: - clinical lab tests - vital signs - electrocardiograms - monitoring for adverse events - physical exams - eye exams(throughout the study)
研究者
研究点 (1)
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