NCT01359579终止1 期
A Phase 1, Open-label, Pharmacokinetic, Safety, and Tolerability Study of a Single Oral Dose of Varespladib Methyl in Subjects With Normal Renal Function, and 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
- 终止
- 入组人数
- 28
- 试验地点
- 3
- 主要终点
- Measure of blood and urine levels of varespladib in subjects with renal impairment in comparison to subjects with normal renal function
研究概览
简要总结
The purpose of this study is to compare and evaluate the pharmacokinetic characteristics and the safety of varespladib methyl in mild or moderate renal impairment patients and healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and non-pregnant, non-lactating females 18 years or older with a BMI of 18-40 kg/m2 inclusive.
- •Regarding renal function, subjects will be classified as either normal or as suffering from mild,moderate or severe renal impairment. Classification of renal impairment will be estimated by the MDRD and Cockcroft-Gault formulae
排除标准
- •Any disease, condition and/or chronic medications which might compromise the hematologic, cardiovascular, pulmonary renal, gastrointestinal, hepatic, or central nervous system; or other conditions that might interfere with the distribution, metabolism or excretion of study drug, or would place the subject at increased risk
- •Evidence of significant respiratory, gastrointestinal or hepatic disease at screening
- •Positive screen for hepatitis B surface antigen, or HIV
- •Positive test in drugs of abuse screens or alcohol on admission to the clinic
研究组 & 干预措施
Subjects with mild renal impairment
Experimental
干预措施: varespladib methyl (Drug)
Subjects with moderate renal impairment
Experimental
干预措施: varespladib methyl (Drug)
Subjects with normal renal function
Experimental
干预措施: varespladib methyl (Drug)
Subjects with severe renal impairment
Experimental
干预措施: varespladib methyl (Drug)
结局指标
主要结局
Measure of blood and urine levels of varespladib in subjects with renal impairment in comparison to subjects with normal renal function
时间窗: PK samples will be collected predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 48, and 72 hours postdose
次要结局
- Safety measures to include adverse events and changes in clinical laboratory results(From admistration of study drug through follow-up on Day 8)
研究者
研究点 (3)
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