NCT02182037已完成1 期
Safety, Pharmacodynamics, and Pharmacokinetics After Single Oral Administration of 1, 5, 10, 30, 100, 200 and 400 mg BIBT 1011 BS as Drinking Solution in Healthy Subjects. An Open, Placebo-controlled, Randomised Study, 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
- 56
- 主要终点
- Determination of international normalized ration (INR)
研究概览
简要总结
A study to assess safety, pharmacokinetics and the effect of BIBT 986 BS, given as BIBT 1011 BS, on 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 45 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 ≤ 45 years
- •Body Mass Index ≥ 18.5 and ≤ 29.9 kg/m2
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, immunological, hormonal disorders
- •History of orthostatic hypotension, fainting spells or blackouts
- •Diseases 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
- •any bleeding disorder including prolonged or habitual bleeding
- •other hematologic disease
- •cerebral bleeding (e.g. after a car accident)
- •commotio cerebri
- •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 (> 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
- •History of any familial bleeding disorder
- •Thrombocytes < 150000/µl
研究组 & 干预措施
BIBT 1011 BS
Experimental
干预措施: Single rising doses of BIBT 1011 BS (Drug)
BIBT 1011 BS placebo
Placebo Comparator
干预措施: BIBT 1011 BS placebo (Drug)
结局指标
主要结局
Determination of international normalized ration (INR)
时间窗: Pre-dose, up to 48 hours after start of treatment
Determination of activated partial thromboplastin time (aPTT)
时间窗: Pre-dose, up to 48 hours after start of treatment
次要结局
- Assessment of plasma concentration time profiles of BIBT 986 BS(Pre-dose, up to 48 hours after start of treatment)
- Total mean time of residence of BIBT 986 BS- molecules in the body (MRTtot)(Pre-dose, up to 48 hours after start of treatment)
- Apparent volume of distribution of the analytes during the terminal phase (Vz/f)(Pre-dose, up to 48 hours after start of treatment)
- Terminal elimination half life of BIBT 986 BS in plasma (t1/2)(Pre-dose, up to 48 hours after start of treatment)
- Determination of thrombin time (TT)(Pre-dose, up to 48 hours after start of treatment)
- Amount excreted over the 24 hour sampling period (Ae0-24)(Pre-dose, up to 24 hours after start of treatment)
- Total clearance after oral administration (CLtot/F)(Pre-dose, up to 48 hours after start of treatment)
- Maximum concentration of BIBT 986 BS in plasma (Cmax)(Pre-dose, up to 48 hours after start of treatment)
- Area under the concentration time curve for BIBT 986 BS (AUC)(Pre-dose, up to 48 hours after start of treatment)
- Time from dosing to when the plasma concentration reaches Cmax after a single extravascular dose (tmax)(Pre-dose, up to 48 hours after start of treatment)
- Number of patients with adverse events(Up to 17 days)
- Assessment of BIBT 986 BS plasma concentration- aPTT relationship(Pre-dose, up to 48 hours after start of treatment)
- Determination of ecarin clotting time (ECT)(Pre-dose, up to 48 hours after start of treatment)
研究者
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