NCT01763190已完成1 期
An Open-label Pharmacokinetic and Tolerability Study of SAR302503 Given as a Single 300 mg Dose in Subjects With Mild, Moderate and Severe Renal Impairment, and in Matched Subjects With Normal Renal Function
Bristol-Myers Squibb3 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2012年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 3
- 主要终点
- Pharmacokinetic parameter: Cmax, AUClast and AUC
研究概览
简要总结
Primary Objective:
To study the effect of mild, moderate and severe renal impairment on the pharmacokinetics of SAR302503.
Secondary Objective:
To assess the tolerability of SAR302503 given as a single 300 mg dose in subjects with mild, moderate and severe renal impairment and in matched subjects with normal renal function.
详细描述
study duration = 17 to 35 days
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 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
SAR302503
Experimental
single treatment of 300 mg oral dose of SAR302503
干预措施: SAR302503 (Drug)
结局指标
主要结局
Pharmacokinetic parameter: Cmax, AUClast and AUC
时间窗: 12 days
次要结局
- Safety parameters including laboratory tests(16 days)
- Safety parameters including ECG parameters(16 days)
- Pharmacokinetic parameters : unbound AUC, unbound Cmax, CL/F, Vss/F , t1/2z, t1/2eff, Rac, pred(12 days)
- Safety parameters including Clinical tests(16 days)
- Number of subjects with adverse events (AEs)(16 days)
研究者
研究点 (3)
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