An Open Label Study of the Pharmacokinetics of DMF and the Effects of DMF on Exploratory Biomarkers in Subjects With Secondary Progressive Multiple Sclerosis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The primary objective of the study is to investigate the PK (drug level) of DMF(study drug) in CSF with SPMS.
研究概览
简要总结
The purpose of this study is to explore whether DMF (Dimethyl Fumarate) or MMF (monomethyl fumarate) its main bioactive metabolite, is capable of entering the central nervous system in SPMS patients that are being treated with Tecfidera®. PK samples (pharmacokinetics - or the amount of study drug in blood) will be tested to compare with PK samples, the amount of study drug, in spinal fluid (CSF).
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
- 25 Years 至 65 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
Group 1
There will be 4 CSF sampling groups at the Week 6 visit for PK assessment:
- Four subject for CSF samples 3 hours after dosing
干预措施: BG00012 (DMF) (Tecfidera®.) (Drug)
Group 2
- Four subjects for CSF samples 5 hours after dosing
干预措施: BG00012 (DMF) (Tecfidera®.) (Drug)
Group 3
- Four subjects for CSF samples 7 hours after dosing
干预措施: BG00012 (DMF) (Tecfidera®.) (Drug)
Group 4
- Four subjects for predose CSF samples
干预措施: BG00012 (DMF) (Tecfidera®.) (Drug)
结局指标
主要结局
The primary objective of the study is to investigate the PK (drug level) of DMF(study drug) in CSF with SPMS.
时间窗: post-DMF treatment in Week 6
Concentration of DMF in CSF predose and at 3, 5, 7 hours post DMF treatment in week 6.
The primary objective of the study is to investigate the PK (drug level) of DMF(study drug) in plasma in subjects with SPMS.
时间窗: treatment in week 6
Concentration of DMF in plasma predose and at 2,3,5,6, 7 and 8 hours post-DMF treatment at Week 6
The primary objective of the study is to investigate the PK (drug level) of MMF(the primary metabolite of study drug) in CSF with SPMS.
时间窗: treatment in week 6
Concentration of MMF in CSF predose and at 3, 5, 7 hours post DMF treatment in week 6.
The primary objective of the study is to investigate the PK (drug level) of MMF( the primary metabolite of study drug) in plasma in subjects with SPMS.
时间窗: treatment in week 6
Concentration of MMF in plasma predose and at 2,3,5,6, 7 and 8 hours post-DMF treatment at Week 6
The primary objective of the study is to investigate the PK (drug level) of DMF conjugate (study drug) in CSF with SPMS.
时间窗: treatment in week 6
Concentration of DMF conjugate in CSF predose and at 3, 5, 7 hours post DMF treatment in week 6.
The primary objective of the study is to investigate the PK (drug level) of DMF conjugate (study drug) in plasma in subjects with SPMS.
时间窗: treatment in week 6
Concentration of DMF conjugate in plasma predose and at 2,3,5,6, 7 and 8 hours post-DMF treatment at Week 6
The primary objective of the study is to investigate the PK (drug level) of MMF (the primary metabolite of study drug) conjugate in CSF with SPMS.
时间窗: treatment in week 6
Concentration of MMF conjugate in CSF predose and at 3, 5, 7 hours post DMF treatment in week 6.
The primary objective of the study is to investigate the PK (drug level) of MMF( the primary metabolite of study drug) conjugate in plasma in subjects with SPMS.
时间窗: treatment in week 6
Concentration of MMF conjugate in plasma predose and at 2,3,5,6, 7 and 8 hours post-DMF treatment at Week 6
次要结局
- A secondary objective is to assess the effects of DMF on biomarkers of oxidative stress in the CSF of subjects with SPMS.(at 28 weeks)
- A secondary objective is to assess the effects of DMF on PD biomarkers downstream of Nrf2 in the CSF of subjects with SPMS.(at 28 weeks)
- A secondary objective is to assess the effects of DMF on biomarkers of inflammation in the CSF of subjects with SPMS.(at 28 weeks)
- A secondary objective is to assess the effects of DMF on biomarkers of neuroaxonal damage in the CSF of subjects with SPMS.(at 28 weeks)
- A secondary objective is to assess the effects of DMF on myelin lipid biomarkers in the CSF of subjects with SPMS.(at 28 weeks)
- A secondary objective is to assess the effects of DMF on pharmacogenomic biomarkers in the CSF of subjects with SPMS.(at 28 weeks)
- A secondary objective is to assess the effects of DMF on RNA samples from CSF cellular pellet for transcriptionomics in the CSF of subjects with SPMS.(at 28 weeks)