NCT01670734已完成1 期
An Open-Label, Pharmacokinetic and Tolerability Study of SAR236553/REGN727 Given as a Single SC Dose in Subjects With Mild and Moderate Hepatic Impairment, and in Matched Subjects With Normal Hepatic 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
- 25
- 试验地点
- 2
- 主要终点
- Pharmacokinetics: Assessment of serum concentrations of alirocumab SAR236553 (REGN727)
研究概览
简要总结
Primary Objective:
Study the effect of mild or moderate hepatic impairment on the pharmacokinetics of alirocumab SAR236553 (REGN727).
Secondary Objectives:
- Assess the safety and tolerability of alirocumab SAR236553 (REGN727) in patients with mild and moderate hepatic impairment and in matched subjects with normal hepatic function.
- Assess the pharmacodynamic profile of alirocumab SAR236553 (REGN727) in patients with hepatic impairment and in matched subjects with normal hepatic function.
详细描述
Total duration of the study per subject (excluding screening) is about 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
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
alirocumab SAR236553 (REGN727) - mild hepatic function
Experimental
Injection through subcutaneous (SC) administration in patients with mild hepatic function
干预措施: alirocumab SAR236553 (REGN727) (Drug)
alirocumab SAR236553 (REGN727) - moderate hepatic function
Experimental
Injection through subcutaneous (SC) administration in patients with moderate hepatic function
干预措施: alirocumab SAR236553 (REGN727) (Drug)
alirocumab SAR236553 (REGN727) - normal hepatic function
Experimental
Injection through subcutaneous (SC) administration in patients with normal hepatic function
干预措施: alirocumab SAR236553 (REGN727) (Drug)
结局指标
主要结局
Pharmacokinetics: Assessment of serum concentrations of alirocumab SAR236553 (REGN727)
时间窗: Up to 12 weeks
次要结局
- Assessment of PK parameter - apparent total body clearance (CL/F)(Up to 12 weeks)
- Assessment of PK parameter - Distribution volume at the steady-state (Vss/F)(Up to 12 weeks)
- Assessment of PK parameter - time to maximum concentration (tmax)(Up to 12 weeks)
- Assessment of PK parameter - Mean Residence Time (MRT [area])(Up to 12 weeks)
- Pharmacodynamics: Change in LDL-C from baseline(Up to 12 weeks)
- Number of participants with Adverse Events(Up to 12 weeks)
- Assessment of PK parameter - terminal elimination half-life (t1/2z) [(Up to 12 weeks)
研究者
研究点 (2)
Loading locations...
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