临床试验/NCT01035515

NCT01035515已完成1 期

A Single-Center, Randomized, Placebo-Controlled, Double-Blind, Crossover Study to Evaluate the Cardiovascular Effects of Single Doses of Oral BIIB014 in Healthy Volunteers

Biogen1 个研究点分布在 1 个国家目标入组 24 人开始时间: 2009年12月最近更新: 2010年6月22日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Biogen
入组人数: 24
试验地点: 1
主要终点: Supine Blood pressure

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The study will examine the effects of a single dose of BIIB014 on blood pressure and haemodynamic variables in healthy volunteers over 24 hours.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
盲法: Double (Participant, Investigator)

入排标准

年龄范围: 18 Years 至 50 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•Healthy male or female subjects
•Between the ages of 18 and 50, inclusive.
•Must have a body mass index (BMI) between 19 kg/m2 and 30 kg/m2, inclusive

排除标准

•Clinically significant abnormalities (as determined by the Investigator)
•Other unspecified reason that would make the subject unsuitable for enrollment (as determined by the Investigator)

研究组 & 干预措施

Arm Five

Experimental

Arm 5 of 6 cross-over arms

干预措施: BIIB014 50mg (Drug)

Arm One

Experimental

Arm 1 of 6 cross-over arms

干预措施: Placebo (Drug)

Arm One

Experimental

Arm 1 of 6 cross-over arms

干预措施: BIIB014 50mg (Drug)

Arm One

Experimental

Arm 1 of 6 cross-over arms

干预措施: BIIB014 100mg (Drug)

Arm Two

Experimental

Arm 2 of 6 cross-over arms

干预措施: Placebo (Drug)

Arm Two

Experimental

Arm 2 of 6 cross-over arms

干预措施: BIIB014 50mg (Drug)

Arm Two

Experimental

Arm 2 of 6 cross-over arms

干预措施: BIIB014 100mg (Drug)

Arm Three

Experimental

Arm 3 of 6 cross-over arms

干预措施: Placebo (Drug)

Arm Three

Experimental

Arm 3 of 6 cross-over arms

干预措施: BIIB014 50mg (Drug)

Arm Three

Experimental

Arm 3 of 6 cross-over arms

干预措施: BIIB014 100mg (Drug)

Arm Four

Experimental

Arm 4 of 6 cross-over arms

干预措施: Placebo (Drug)

Arm Four

Experimental

Arm 4 of 6 cross-over arms

干预措施: BIIB014 50mg (Drug)

Arm Four

Experimental

Arm 4 of 6 cross-over arms

干预措施: BIIB014 100mg (Drug)

Arm Five

Experimental

Arm 5 of 6 cross-over arms

干预措施: Placebo (Drug)

Arm Five

Experimental

Arm 5 of 6 cross-over arms

干预措施: BIIB014 100mg (Drug)

Arm Six

Experimental

Arm 1 of 6 cross-over arms

干预措施: Placebo (Drug)

Arm Six

Experimental

Arm 1 of 6 cross-over arms

干预措施: BIIB014 50mg (Drug)

Arm Six

Experimental

Arm 1 of 6 cross-over arms

干预措施: BIIB014 100mg (Drug)

结局指标

主要结局

Supine Blood pressure

时间窗: 24 hours

次要结局

未报告次要终点

研究者

发起方

Biogen

申办方类型

Industry

研究点 (1)

Loading locations...

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