Safety/Tolerability, Pharmacokinetics, and Pharmacodynamics of BIBB 1464 MS in Healthy Male Subjects, Combined With Preliminary Evaluation of Relative Bioavailability and Effect of Food
Safety/Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Oral Doses of 0.25 mg, 0.75 mg, 2 mg, 6 mg, and 10 mg BIBB 1464 MS (Tablet) in Healthy Male Subjects, Combined With Preliminary Evaluation of Relative Bioavailability and Effect of Food of the Dose of 0.75 mg or 2 mg or 6 mg (Two-stage Trial Design With Randomised Double Blind Placebo Controlled Rising Dose Phase and Subsequent Randomised, Open Parallel Group Phase)
Safety, pharmacodynamics and pharmacokinetics of 0.25, 0.75, 2.0, 6.0, and 10 mg BIBB 1464 p.o once daily in a rising dose group-comparison (placebo controlled, double blind, randomized per dose level).
Relative Bioavailability of 0.75 mg or 2 mg or 6 mg ( tablet vs. solution, intraindividual comparison), preliminary assessment of food effects (interindividual comparison)
Two-stage Trial Design With Randomised Double Blind Placebo Controlled Rising Dose Phase and Subsequent Randomised, Open Parallel Group Phase).
MS (Tablet) in Healthy Male Subjects, Combined With Preliminary Evaluation of Relative Bioavailability and Effect of Food of the Dose of 0.75 mg or 2 mg or 6 mg (Two-stage Trial Design With Randomised Double Blind Placebo Controlled Rising Dose Phase and Subsequent Randomised, Open Parallel Group Phase).
研究概览
地位
条件
研究类型
注册 (实际的)
阶段
- 阶段1
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Healthy subjects as determined by results of screening
- Signed written informed consent in accordance with good clinical practice (GCP) and local legislation
- Age > 18 and < 55 years
- Broca > - 20% and < + 20%
Exclusion Criteria:
- Any findings of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance.
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal (including thyroid) disorder
- Surgery of the gastro-intestinal tract (except appendectomy)
- Disease of the central nervous system (such as epilepsy) or psychiatric 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) (<= 1 month prior to administration or during the trial)
- Use of any drugs which might influence the result of the trial (<= 10 days prior to administration or during the trial)
- Participation in another trial with an investigational drug (<= 2 month prior to administration or during the trial)
- Smoker (> 10 cigarettes or > 3 cigars or >3 pipes/day)
- Inability to refrain from smoking during the period of the study
- Known alcohol (>60 g/day) or drug abuse
- Blood donation (<=1 month prior to administration)
- Excessive physical activities (<5 days prior to administration)
- Any laboratory value outside the normal range of clinical relevance
- History of hemorrhagic diatheses
- History of gastro-intestinal ulcer, perforation or bleeding
- History of bronchial asthma
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:BIBB 1464 MS single rising dose fed
|
|
实验性的:BIBB 1464 MS tablet fasted
|
|
有源比较器:BIBB 1464 MS solution fasted
|
|
安慰剂比较:BIBB 1464 MS placebo
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
发生不良事件的患者人数
大体时间:最后一次给药后最多 72 小时
|
最后一次给药后最多 72 小时
|
Maximum drug plasma concentration (Cmax)
大体时间:Up to 38 hours after drug administration
|
Up to 38 hours after drug administration
|
Time to reach the maximum concentration of the analyte in plasma (tmax)
大体时间:Up to 38 hours after drug administration
|
Up to 38 hours after drug administration
|
Total area under the plasma drug concentration-time curve (AUC)
大体时间:Up to 38 hours after drug administration
|
Up to 38 hours after drug administration
|
Apparent terminal half-life of the analyte in plasma (t1/2)
大体时间:Up to 38 hours after drug administration
|
Up to 38 hours after drug administration
|
Total plasma clearance divided by the systemic availability factor (CL/f)
大体时间:Up to 38 hours after drug administration
|
Up to 38 hours after drug administration
|
Dose normalized AUC0-38h ( NAUC0-38h)
大体时间:Up to 38 h after drug administration
|
Up to 38 h after drug administration
|
Mean residence time, total (MRTtot)
大体时间:Up to 38 hours after drug administration
|
Up to 38 hours after drug administration
|
Number of patients with clinical significant findings in vital signs
大体时间:Up to 38 hours after drug administration
|
Up to 38 hours after drug administration
|
Number of patients with clinical significant findings in electrocardiogram (ECG)
大体时间:Up to 38 hours after drug administration
|
Up to 38 hours after drug administration
|
Number of patients with clinical significant findings in physical examination
大体时间:Up to 38 hours after drug administration
|
Up to 38 hours after drug administration
|
Investigator assessed tolerability on a 4 point scale
大体时间:Up to 38 hours after drug administration
|
Up to 38 hours after drug administration
|
Monoepoxysqualene (MES) plasma concentration
大体时间:Up to 38 hours after drug administration
|
Up to 38 hours after drug administration
|
Amount of drug excreted in urine
大体时间:Up to 38 h after drug administration
|
Up to 38 h after drug administration
|
合作者和调查者
出版物和有用的链接
有用的网址
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 1178.1
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