A Multi-center, Open-label, 2-treatment, Single-sequence Clinical Study to Evaluate the Effects of a Single 200 mg Subcutaneous Injection of Sarilumab on the Pharmacokinetics of a Single 40 mg Oral Dose of Simvastatin, With Optional 1-year Extension of Open Label Treatment of Sarilumab, in Patients With Rheumatoid Arthritis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 19
- 试验地点
- 5
- 主要终点
- Assessment of PK parameters - area under curve from zero time until the last measurable concentration (AUClast) and AUC for simvastatin
研究概览
简要总结
Primary Objective:
To evaluate the effect of a single 200 mg subcutaneous injection of sarilumab on the pharmacokinetics of simvastatin in patients with rheumatoid arthritis
Secondary Objective:
To describe the safety and efficacy (exploratory) of sarilumab
详细描述
The duration of the entire study per patient completing both Parts A and B is expected to be approximately 58 weeks (not including Screening).
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
- Health Services Research
- 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
Sarilumab SAR153191 (REGN88)
Single dose of simvastatin before and after sarilumab administration
干预措施: sarilumab SAR153191 (REGN88) (Drug)
Sarilumab SAR153191 (REGN88)
Single dose of simvastatin before and after sarilumab administration
干预措施: simvastatin (Drug)
结局指标
主要结局
Assessment of PK parameters - area under curve from zero time until the last measurable concentration (AUClast) and AUC for simvastatin
时间窗: Day 1 of Period 1 and Day 8 of Period 2
次要结局
- Assessment of additional PK parameters for simvastatin(Day 1 of Period 1 and Day 8 of Period 2)
- Assessment of additional PK parameters for simvastatin acid(Day 1 of Period 1 and Day 8 of Period 2)
- Safety assessment of sarilumab up to 1 year )(From Day 1 of Period 1 up to a maximum of 1 year (week 58))