NCT01239459已完成1 期
An Open-label Pharmacokinetic and Tolerability Study of Teriflunomide Given as a Single 14 mg Dose in Subjects With Severe Renal Impairment, and in Matched Subjects With Normal Renal Function
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
- Sanofi
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Pharmacokinetic parameters of Teriflunomide determined from plasma concentration (Maximum plasma concentration (Cmax), Area under the plasma concentration curve (AUClast and AUC))
研究概览
简要总结
Primary Objective:
- To determine the effect of severe renal impairment on the pharmacokinetic profile of teriflunomide administered as a single 14 mg dose as compared to healthy subjects
Secondary Objective:
- To assess the tolerability of teriflunomide administered as a single 14 mg dose in subjects with severe renal impairment compared to subjects with normal renal function.
详细描述
The total study duration per subject is 11-15 weeks broken down as follows:
- Screening: up to 3 weeks
- Hospitalization: 3 days (admission 1 day prior to study drug intake)
- Follow-up: 10 -12 weeks
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 75 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
Severe impaired renal function
Experimental
Subjects with severe renal impairment as defined by Cockroft-Gault formula
干预措施: Teriflunomide HMR1726 (Drug)
Severe impaired renal function
Experimental
Subjects with severe renal impairment as defined by Cockroft-Gault formula
干预措施: Cholestyramine (Drug)
Normal renal function
Experimental
Subjects with normal renal function as defined by Cockroft-Gault formula
干预措施: Teriflunomide HMR1726 (Drug)
Normal renal function
Experimental
Subjects with normal renal function as defined by Cockroft-Gault formula
干预措施: Cholestyramine (Drug)
结局指标
主要结局
Pharmacokinetic parameters of Teriflunomide determined from plasma concentration (Maximum plasma concentration (Cmax), Area under the plasma concentration curve (AUClast and AUC))
时间窗: 56 days
次要结局
- Clinical safety evaluation (AE reporting, laboratory tests (hematology, biochemistry and urinalysis), vital signs and ECG parameters)(Up to 12 weeks (until the end of study visit))
研究者
研究点 (1)
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