Tolerability and Pharmacokinetics/-Dynamics of Single Rising Doses of 0.1 mg, 0.3 mg, 1.0 mg, 2.5 mg, 5.0 mg, and 10.0 mg BIBT 986 BS (IV Infusion Over 30 Minutes) in Healthy Male Subjects. Placebo Controlled, Double Blind Randomised at Each Dose Level

Boehringer Ingelheim0 个研究点目标入组 47 人开始时间: 2002年7月最近更新: 2014年10月1日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Boehringer Ingelheim
入组人数: 47
主要终点: AUC0-∞ (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity after single dose administration)

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记录与标识符相似试验

研究概览

简要总结

Study to assess the tolerability of BIBT 986 BS after intravenous infusions of 0.1, 0.3, 1.0, 2.5, 5.0, and 10 mg, to assess the pharmacokinetics of BIBT 986 BS after intravenous infusion and to assess the effect of BIBT 986 BS on blood coagulation parameters

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 male 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
•BMI >= 18.5 and <= 29.9 kg/m2

排除标准

•Any finding of the medical examination (including blood pressure, pulse rate, and electrocardiogram) deviating from normal and of clinical relevance
•Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic or hormonal disorders
•Surgery of gastrointestinal tract (except appendectomy)
•Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
•Relevant history of orthostatic hypotension, fainting spells or blackouts
•Any bleeding disorder including prolonged or habitual bleeding
•History of other hematologic disease, cerebral bleeding (e.g. after a car accident), commotio cerebri
•Chronic or relevant acute infections
•History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
•Seasonal rhinitis
•Thrombocytes < 150000/μl
•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 results of the trial (< 10 days prior to administration or during the trial)
•Participation in another trial with an investigational drug (< 2 months prior to administration or during trial)
•Smoker (> 10 cigarettes or >3 cigars or >3 pipes/day)
•Alcohol abuse (> 60 g/day)
•Drug abuse
•Use of methylxanthine-containing drinks or foods (coffee, tea, cola, energy drinks, chocolate, etc.), grapefruit or grapefruit juice, alcohol, green tea, or tobacco < 5 days prior to administration of study drug or during trial
•Blood donation or loss > 400 ml, < 1 month prior to administration or during the trial
•Excessive physical activities < 5 days prior to administration of study drug or during trial
•Clinically relevant laboratory abnormalities
•Any ECG value outside of the reference range of clinical relevance including, but not limited to QRS interval > 110 ms or QTcB > 450 ms
•Inability to comply with dietary regimen of study centre
•Inability to comply with investigator's instructions

研究组 & 干预措施

BIBT 986 BS - single rising dose

Experimental

干预措施: BIBT 986 BS - single rising dose (Drug)

Placebo

Placebo Comparator

干预措施: Placebo (Drug)

结局指标

主要结局

AUC0-∞ (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity after single dose administration)