Safety, Pharmacodynamics, and Pharmacokinetics After Multiple Oral Doses of 200 and 300 mg BIIB 722 CL Tablet Tid and 300 and 450 mg BIIB 722 CL Tablet Bid Over 7 Days to Healthy Volunteer Subjects. An Open Study, Placebo-controlled Randomised Double Blind at Each Dose Level.
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 10
- 主要终点
- Area under the concentration-time curve of the analyte in plasma (AUC)
研究概览
简要总结
Study to assess safety, pharmacodynamics and pharmacokinetics of BIIB 722 CL
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
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
- •Healthy males
- •18 to 55 years of age
- •Broca index >= -20% and <= +20%
- •Written informed consent according to Good Clinical Practice (GCP) and local legislation
排除标准
- •Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
- •History or current gastrointestinal hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders
- •History of orthostatic hypotension, fainting spells or blackouts
- •Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- •Chronic or relevant acute infections
- •History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- •Intake of drugs with a long half-life (> 24 hours) within 1 month prior to administration
- •Use of any drugs, which might influence the results of the trial within 10 days prior to administration or during the trial
- •Participation in another trial with an investigational drug within 2 months prior to administration of during trial
- •Smoker (> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on study days
- •Alcohol abuse (> 60 g/day)
- •Drug abuse
- •Blood donation within 1 month prior to administration or during the trial
- •Excessive physical activities within 5 days prior to administration or during the trial
- •Any laboratory value outside the clinically accepted reference range
研究组 & 干预措施
BIIB 722 CL
干预措施: BIIB 722 CL (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Area under the concentration-time curve of the analyte in plasma (AUC)
时间窗: up to day 7
Maximum measured concentration of the analyte in plasma (Cmax)
时间窗: up to day 7
Time to maximum measured concentration of the analyte in plasma (tmax)
时间窗: up to day 7
Total mean residence time of the analyte in the body (MRTtot)
时间窗: up to day 7
Total clearance of the analyte in plasma (CLtot/f)
时间窗: up to day 7
Terminal half-life of the analyte in plasma (t1/2)
时间窗: up to day 7
Amount of the analyte excreted in urine (Ae)
时间窗: up to day 7
Dose proportionality
时间窗: up to day 7
assessed by AUC
Accumulation factor
时间窗: up to day 7
(predose concentration/concentration after 8 hours)
Time to reach steady state
时间窗: up to day 7
Thrombocytic Na-H exchange (NHE-1) inhibition by AUC of pH recovery
时间窗: up to day 7
in vitro fluorescence
次要结局
- Number of subjects with adverse events(up to day 12)
- Number of subjects with clinically significant findings in vital functions(up to day 12)
- Number of subjects with clinically significant findings in laboratory tests(up to day 12)