Study to Investigate the Pharmacokinetics, Safety, and Tolerability of BG00012 (Dimethyl Fumarate) When Delivered to Different Regions of the Gastrointestinal Tract in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- The maximum observed concentration: Cmax
研究概览
简要总结
The primary objective of this study is to evaluate the pharmacokinetics (PK) profile of monomethyl fumarate (MMF) following delivery of BG00012 (dimethyl fumarate, DMF) 120 mg (Part 1) and BG00012 240 mg (Part 2) to varying regions within the GI tract in healthy volunteers. The secondary objective of this study is to evaluate the safety and tolerability profile following the delivery of BG00012 120 mg (Part 1) and BG00012 240 mg (Part 2) to varying regions within the GI tract in healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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
- 是
入选标准
- •Healthy males or non-pregnant, non-lactating healthy females.
- •Body mass index (BMI) of 18 through 35 kg/m
- •Subjects of childbearing potential (including males) must practice effective contraception during the study and be willing and able to continue contraception for 90 days after their last dose of study treatment
排除标准
- •History of or positive test result at Screening for human immunodeficiency virus (HIV), hepatitis C virus (HCV) antibody, or hepatitis B virus (defined as positive for hepatitis B surface antigen [HBsAg] or hepatitis B core antibody [HBcAb]).
- •Serious infection (e.g., pneumonia, septicemia) within the 3 months prior to first dose.
- •Vaccinations within 4 weeks prior to first dose.
- •History of drug or alcohol abuse (as defined by the Investigator) within the previous 2 years, or regular alcohol consumption in males >21 units per week and females >14 units per week (1 unit = ½ pint of beer, 25 mL of 40% spirit or a 125 mL glass of wine).
- •History of clinically significant gastrointestinal (GI) disease as determined by the Investigator (including Crohn's Disease, Ulcerative Colitis, confirmed diagnosis of active Irritable Bowel Syndrome).
- •History of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, and renal, or other major disease, as determined by the Investigator.
- •NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
BG00012 Part 1
BG00012 120 mg delivered to varying locations of the GI tract
干预措施: dimethyl fumarate (Drug)
BG00012 Part 2
BG00012 240 mg delivered to varying locations of the GI tract
干预措施: dimethyl fumarate (Drug)
结局指标
主要结局
The maximum observed concentration: Cmax
时间窗: Up to week 9
The area under the plasma concentration versus time curve from time zero to time t (the last sampling time with quantifiable monomethyl fumarate [MMF])
时间窗: Up to week 9
The area under the plasma concentration versus time curve from time zero to 24 hours
时间窗: Up to week 9
The time to reach maximum observed concentration: Tmax
时间窗: Up to week 9
The area under the plasma concentration versus time curve from time zero to infinity
时间窗: Up to week 9
The apparent elimination half-life
时间窗: Up to week 9
The time prior to the first quantifiable monomethyl fumarate (MMF) plasma concentration
时间窗: Up to week 9
Area under the plasma concentration versus time curve (AUC) ratio of test regimens compared with reference for Part 1
时间窗: Up to week 9
Area under the plasma concentration versus time curve (AUC) ratio of test regimens compared with reference for Part 2
时间窗: Up to week 9
次要结局
- The number of participants that experience Adverse Events (AEs) and Serious Adverse Events (SAEs)(Up to week 9)