NCT02227030已完成1 期
Tolerability and Pharmacokinetics of Single Oral Administration of 10, 20, 50, 100, 200 and 300 mg BIIB 722 CL (Calculated as Free Base) as Drinking Solution and of 200, 450, 600 and 750 mg BIIB 722 CL as Filmcoated Tablet in Healthy Subjects. An Open Study With Rising Doses, Partly Uncontrolled Intra-individual Comparison, Placebo Randomised Double Blind at Each Dose Level.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 71
- 主要终点
- Total clearance of the analyte in plasma (CLtot/f)
研究概览
简要总结
Safety and pharmacokinetics after oral single rising doses of BIIB 722 CL
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 Electrocardiogram (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 or during trial
- •Smoker (> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on study days
- •Alcohol abuse (> 60g/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 single rising dose
Experimental
干预措施: BIIB 722 CL solution (Drug)
BIIB 722 CL cross over
Experimental
干预措施: BIIB 722 CL solution (Drug)
BIIB 722 CL cross over
Experimental
干预措施: BIIB 722 CL tablet (Drug)
Placebo solution
Placebo Comparator
干预措施: Placebo solution (Drug)
Placebo tablet
Placebo Comparator
干预措施: Placebo tablet (Drug)
结局指标
主要结局
Total clearance of the analyte in plasma (CLtot/f)
时间窗: up to 96 hours after drug administration
Maximum measured concentration of the analyte in plasma (Cmax)
时间窗: up to 96 hours after drug administration
Area under the concentration-time curve of the analyte in plasma (AUC)
时间窗: up to 96 hours after drug administration
Time from dosing to the maximum concentration of the analyte in plasma (tmax)
时间窗: up to 96 hours after drug administration
Total mean residence time of the analyte in the body (MRTtot)
时间窗: up to 96 hours after drug administration
次要结局
- Number of subjects with adverse events(up to 96 hours after drug administration)
- Number of subjects with clinically significant findings in vital functions(up to 96 hours after drug administration)
- Number of subjects with clinically significant findings in laboratory tests(up to 96 hours after drug administration)
- Thrombocytic Na-H exchange (NHE-1) inhibition by AUC of pH recovery(up to 24 hours after drug administration)
研究者
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