A Phase I, Multicenter, Randomized, 12-Week, Open-Label Study to Evaluate the Multiple Dose Pharmacokinetics and Pharmacodynamics of RPC 1063 in Patients With Relapsing Multiple Sclerosis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Celgene
- 入组人数
- 22
- 试验地点
- 6
- 主要终点
- Maximum plasma concentration (Cmax)
研究概览
简要总结
The purpose of this study is to learn about the pharmacokinetics and pharmacodynamics of RPC1063 in RMS.
详细描述
The purpose of this study is to characterize the full pharmacokinetic and pharmacodynamics profiles of RPC1063 in patients with relapsing multiple sclerosis (RMS) following multiple-dose administration of the two different dosing regimens that are being evaluated in the Phase 3 RMS studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •MS, as diagnosed by the revised 2010 McDonald criteria
- •Exhibits a relapsing clinical course consistent with RMS and history of brain MRI lesions consistent with MS
- •Expanded disability status scale (EDSS) score between 0 and 6.0
排除标准
- •Primary progressive MS
- •Clinically relevant cardiovascular conditions or other relevant diseases that could impact the implementation or interpretation of the trial, or put the patient at risk
研究组 & 干预措施
1 mg RPC1063
1 mg RPC1063 oral capsule daily
干预措施: RPC1063 (Drug)
0.5 mg RPC1063
0.5 mg RPC1063 oral capsule daily
干预措施: RPC1063 (Drug)
结局指标
主要结局
Maximum plasma concentration (Cmax)
时间窗: 24 hours after the last RPC1063 dose on Day 85
Maximum plasma concentration (Cmax)
Area under the plasma concentration-time curve (AUC)
时间窗: Approximately 3 months
Area under the plasma concentration-time curve (AUC)
次要结局
- Adverse Events(Up to 28 days after the last RPC1063 dose)
- EDSS (Expanded Disability Status Scale)(Up to the last RPC1036 dose on Day 85)
- Pharmacodynamic response measured in change from baseline in Absolute Lymphocyte Count(Up to 28 days after the last RPC1063 dose)