A Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability, and Pharmacokinetics of BG00012 Administered With and Without 325 mg Aspirin in Healthy Adult Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- • incidence of treatment emergent AEs
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, and PK of different doses and dosing regimens of BG00012 administered with and without ASA compared to placebo
详细描述
Preclinical safety margins for BG00012 allow for a maximum daily dose of 720 mg daily. The study will use a variety of clinical scales, including a flushing scale derived from a validated questionnaire [Norquist 2007], to better understand the safety and tolerability of several doses and dosing regimens of BG00012 up to a total daily dose of 720 mg. The etiology of BG00012-induced flushing will be assessed by collecting relevant biomarker data and the impact of ASA on flushing will be evaluated. Assessments relating to GI symptoms will also be performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
- •Aged 18 to 55 years old, inclusive, at the time of informed consent.
- •Must be in good health, as determined by the Investigator, based on medical history and screening evaluations.
- •Must have a body mass index of 18 to 34 kg/m2, inclusive.
- •Subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment.
排除标准
- •History of any clinically significant cardiac, endocrinologic, GI, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major disease, as determined by the Investigator.
- •History of malignant disease, including solid tumors and hematologic malignancies (except basal cell and squamous cell carcinomas of the skin that have been completely excised and are considered cured).
- •Serious infection (e.g., pneumonia, septicemia) as determined by the Investigator within the 3 months prior to Day
- •Diarrhea, constipation, abdominal pain, flushing, or nausea within 28 days prior to Day
- •History of severe allergic or anaphylactic reactions. Additionally, subjects with a history of intolerance to ASA or non-steroidal anti-inflammatory drugs (NSAIDS) must be excluded.
研究组 & 干预措施
BG00012 plus ASA
干预措施: Dimethyl Fumarate (BG00012) (Drug)
BG00012 plus ASA
干预措施: Aspirin (Drug)
BG00012 plus ASA matching placebo
干预措施: Dimethyl Fumarate (BG00012) (Drug)
BG00012 plus ASA matching placebo
干预措施: ASA matching placebo (Drug)
BG00012 Placebo plus ASA
干预措施: Aspirin (Drug)
BG00012 Placebo plus ASA
干预措施: BG00012 matching placebo (Drug)
BG00012 Placebo plus ASA matching placebo
干预措施: BG00012 matching placebo (Drug)
BG00012 Placebo plus ASA matching placebo
干预措施: ASA matching placebo (Drug)
BG00012
modified dose regimen
干预措施: Dimethyl Fumarate (BG00012) (Drug)
结局指标
主要结局
• incidence of treatment emergent AEs
时间窗: 11 days
• incidence of serious AEs (SAEs)
时间窗: 11 days
• Concentration versus time data for BG00012 (as measured by monomethyl fumarate (MMF), will be collected for each treatment group. Plasma PK parameters will include AUC, Cmax, time to maximum plasma concentration, half life & lagtime.
时间窗: 11 days
• clinical laboratory assessments:
时间窗: 11 days
次要结局
- • incidence, severity, and duration (time of onset until time of resolution) of flushing based on flushing severity measurements.(11 days)
- • concentrations of PGD2 and/or its metabolites in plasma and/or urine and other prostaglandins, as well as other biomarkers in plasma and/or urine(11 days)
- • Incidence, severity, duration, and characteristics of GI events(11 days)