NCT00442871已完成1 期
An Open-Label, Non-Randomized Pharmacokinetic and Safety Study of a Single Oral Dose of 50 mg Eltrombopag in Healthy Subjects and in Subjects With Mild, Moderate, or Severe Renal 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
- 29
- 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 50 mg tablet of SB-497115 is broken down in the body by healthy subjects versus subjects with mild, moderate or severe kidney 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
- Single Group
- 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
- •Healthy or have renal impairment
- •Females (the following requirement applies only if able to have children): agree to doctor approved birth control methods, or partner has had a vasectomy
- •Negative drug, alcohol, and HIV tests.
排除标准
- •Taking a medication or therapy not approved by the study doctor
- •Rapidly changing kidney function
- •Drug or alcohol abuse within past 6 months
- •Used an investigational drug in the past 30 days
- •Females who are pregnant or nursing
- •Have active hepatitis B or C
研究组 & 干预措施
Eltrombopag
Experimental
Eltrombopag 50 mg oral (single dose)
干预措施: eltrombopag (Drug)
结局指标
主要结局
Plasma levels and protein binding of eltrombopag
时间窗: at Day 1 to Day 6.
plasma levels/protein binding for eltrombopag
次要结局
- adverse assessment(Day 1 to followup)
- clinical labs, vital signs, & 12-lead electrocardiograms done(all days but Day 4)
- Safety will be assessed by: -eye exam(at Screening, Day -1, & followup)
研究者
研究点 (1)
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