NCT02214914已完成1 期
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of 5, 10, 25, 50, 100, 200 and 400 mg BI 11634 Solution Administered to Healthy Male Volunteers. Randomised, Double-blind, Placebo Controlled at Each Dose Level. Intra-individual Comparison of Solution to an Immediate Release Tablet Formulation at One Dose Level (50 mg)
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
- Number of subjects with clinically significant findings in ECG
研究概览
简要总结
First evaluation of safety, tolerability, pharmacokinetics and the pharmacodynamic effect of BI 11634 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 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy males according to the following criteria:
- •Based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests
- •Age ≥18 and ≤50 years
- •Haemoglobin within the normal ranges
- •Body Mass Index (BMI) ≥18.5 and BMI ≤29.9 kg/m2
- •Signed and dated written informed consent prior to admission to the study in accordance with Good clinical practice (GCP) and the local legislation
排除标准
- •Relevant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- •Relevant surgery of gastrointestinal tract
- •History of any bleeding disorder or acute blood coagulation defect, for the subject itself or any person of his family as far as known
- •History of gastric ulcera and cholecystectomy
- •Occult blood in feces
- •Relevant diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- •History of relevant orthostatic hypotension, fainting spells or blackouts
- •Relevant chronic or 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 at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
- •Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
- •Use of acetylsalicylic acid or any other non-steroidal anti-inflammatory drugs (NSAID) within 2 weeks of study start until the end of study
- •Participation in another trial with an investigational drug within two months prior to administration or during the trial
- •Alcohol abuse (more than 40 g/day)
- •Drug abuse
- •Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
- •Excessive physical activities (within one week prior to administration or during the trial)
- •Any laboratory value outside the reference range that is of clinical relevance
- •Vulnerable subjects (e.g. persons kept in detention)
- •The subject is not able to understand and comply with protocol requirements, instructions and protocol-stated restrictions
- •Subjects with a history within the past 2 weeks of closed head or torso trauma or deceleration injury such as an automobile accident or fall from a significant height
研究组 & 干预措施
BI 11634 drinking solution
Experimental
single rising dose
干预措施: BI 11634 drinking solution (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
BI 11634 tablet
Experimental
干预措施: BI 11634 tablet (Drug)
结局指标
主要结局
Number of subjects with clinically significant findings in ECG
时间窗: up to 10 days after drug administration
Number of subjects with clinically significant findings laboratory tests
时间窗: up to 10 days after drug administration
Assessment of tolerability by investigator on a 4-point scale
时间窗: up to 10 days after drug administration
Number of subjects with adverse events
时间窗: up to 10 days after drug administration
Number of subjects with clinically significant findings in vital signs (blood pressure, pulse rate)
时间窗: up to 10 days after drug administration
次要结局
- Cmax (maximum measured concentration of the analyte in plasma)(up to 72 hours after drug administration)
- λz (terminal rate constant in plasma)(up to 72 hours after drug administration)
- t1/2 (terminal half-life of the analyte in plasma)(up to 72 hours after drug administration)
- MRTpo (mean residence time of the analyte in the body after oral administration)(up to 72 hours after drug administration)
- Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)(up to 72 hours after drug administration)
- fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2)(up to 48 hours after drug administration)
- Activated partial thromboplastin time (aPTT) ratios between groups(up to 72 hours after drug administration)
- AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 up to the last quantifiable data point)(up to 72 hours after drug administration)
- CL/F (apparent clearance of the analyte in plasma after extravascular administration)(up to 72 hours after drug administration)
- Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2)(up to 48 hours after drug administration)
- Maximum international normalized ratio (INR)(up to 72 hours after drug administration)
- Time to maximum inhibition of thrombin generation BI 11634(up to 24 hours after drug administration)
- Percent inhibition of thrombin generation by BI 11634(up to 24 hours after drug administration)
- tmax (time from dosing to maximum measured concentration)(up to 72 hours after drug administration)
- AUC0-inf (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)(up to 72 hours after drug administration)
- CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2)(up to 48 hours after drug administration)
- Maximum aPTT prolongation(up to 72 hours after drug administration)
- % inhibition of endogenous Factor Xa(up to 72 hours after drug administration)
- Percent peak inhibition of thrombin generation(up to 24 hours after drug administration)
- Percent prolongation of lag time(up to 24 hours after drug administration)
- Area under the inhibition of the endogenous thrombin generation-time curve(up to 24 hours after drug administration)
- Maximum prolongation of blood coagulation time(up to 72 hours after drug administration)
研究者
相似试验
已完成
1 期
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple, Rising Oral Doses of BI 11634 Oral Solution in Healthy Male VolunteersHealthyNCT02214940Boehringer Ingelheim48
已完成
1 期
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Doses of BI 1356 BS in Healthy Male VolunteersHealthyNCT02183298Boehringer Ingelheim36
已完成
1 期
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BI 1356 BS as Tablet in Patients With Type 2 DiabetesDiabetes Mellitus, Type 2NCT02183415Boehringer Ingelheim77
已完成
1 期
Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 113823 Powder in Bottle (PiB) and Tablet in Healthy Male VolunteersHealthyNCT02259972Boehringer Ingelheim63
已完成
1 期
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Rising Oral Doses and Multiple Rising Oral Doses of BI 1356 BS in Healthy Male VolunteersHealthyNCT02183311Boehringer Ingelheim56