NCT00837785已完成1 期
A 24-Hour Pharmacokinetic Determination of BG00012 After Single-Day Oral Administration in Subjects With Multiple Sclerosis
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
- Biogen
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- To establish a PK profile of MMF during a 24-hour BG00012 dosing period in subjects with RRMS
研究概览
简要总结
To establish a pharmacokinetic (PK) profile of BG00012, as measured by its primary metabolite, monomethyl fumarate (MMF), during a 24-hour dosing period in subjects with relapsing-remitting multiple sclerosis (RRMS), with a variety of baseline demographic characteristics.
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
- •Aged 18 to 55 years old, inclusive, at the time of informed consent.
- •Have a confirmed diagnosis of RRMS according to McDonald criteria #1-
- •Be ambulatory.
排除标准
- •Primary progressive, secondary progressive, or progressive-relapsing multiple sclerosis (PRMS).
- •History of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic (other than MS), dermatologic, psychiatric, renal, oncologic, anaphylaxis or other major diseases, as determined by the Investigator.
- •Current enrollment in any other drug, biologic, or device study or treatment with another investigational drug within 6 months or 5 half-lives of the investigational product, whichever time period is longer.
- •Serious infection (e.g., pneumonia, septicemia) within the 2 months prior to Day -
- •Pregnant or nursing women.
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
1
Experimental
240 mg (two 120 mg capsules) twice a day
干预措施: BG00012 (Drug)
2
Experimental
240 mg (two 120 mg capsules) three times a day
干预措施: BG00012 (Drug)
结局指标
主要结局
To establish a PK profile of MMF during a 24-hour BG00012 dosing period in subjects with RRMS
时间窗: 24 Hours
次要结局
- To explore the relationship of differences in baseline demographics and dosing factors in the disposition of BG00012(24 Hours)
研究者
研究点 (1)
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