NCT01069913已完成1 期
A Pharmacokinetics Profile Determination of BG00012 Standard Formulation and the BG00012 Active Pharmaceutical Ingredient (API) After a Single Oral Dose Administered to Healthy Male Volunteers
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
- 14
- 主要终点
- PK profiles of the current BG00012 standard formulation and the BG00012 API formulation in healthy volunteers. Primary PK parameter will be the area under the plasma concentration curve
研究概览
简要总结
The purpose of this study is to measure two different formulations of BG00012 to determine how much of each formulation of BG00012 reaches the blood stream and how long it takes the body to get rid of it, when given as a single dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Males 18 to 55 years old, inclusive, at the time of informed consent.
- •Must weigh between 50 kg and 110 kg, inclusive.
- •Must have a body mass index (BMI) between 19 kg/m2 and 30 kg/m2, inclusive.
- •All subjects 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.
- •Must be a non-smoker, and no use of chewing tobacco, for at least 6 months prior to Day -
- •Must have a screening physical examination and ECG without any clinically significant abnormality (as determined by the Investigator).
排除标准
- •History of malignancy (subjects with basal cell carcinoma that has been completely excised prior to study entry remain eligible).
- •History of severe allergic or anaphylactic reaction.
- •History of any clinically significant endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, and renal, or other major diseases, as determined by the Investigator.
- •Clinically significant abnormal hematology or blood chemistry values, as determined by the Investigator.
- •Serious infection (e.g., pneumonia, septicemia) within the 2 months prior to Day -1.
研究组 & 干预措施
BG00012
Active Comparator
BG00012 Standard Formulation
干预措施: BG00012 (Drug)
BG00012 API
Active Comparator
BG00012 API
干预措施: BG00012 (Drug)
结局指标
主要结局
PK profiles of the current BG00012 standard formulation and the BG00012 API formulation in healthy volunteers. Primary PK parameter will be the area under the plasma concentration curve
时间窗: 4 days post dosing period 2
次要结局
- To assess the safety and tolerability of the current oral BG00012 standard formulation and the encapsulated oral BG00012 API(4 days after dosing period 2)
研究者
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