NCT02183389已完成1 期
Relative Bioavailability of a Single Oral Dose of Warfarin (10 mg qd) After Coadministration With Multiple Oral Doses of BI 1356 (5 mg qd) Compared to the Bioavailability of a Single Oral Dose of Warfarin (10 mg qd) Alone in Healthy Male Volunteers (an Open Label, Two Periods, Fixed-sequence, Clinical Phase I Study)
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
- 18
- 主要终点
- Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
研究概览
简要总结
To investigate whether and to what extent BI 1356 affects pharmacokinetic and pharmacodynamic parameters of warfarin
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), clinical laboratory tests
- •Age ≥ 18 and Age ≤ 50 years
- •BMI ≥ 18.5 and BMI ≤ 29.9 kg/m2 (Body Mass Index)
- •Signed and dated written informed consent prior to admission to the study in accordance with good clinical practice (GCP) and the local legislation
- •Homozygote wild-type carriers (*1/*1) of cytochrome P 450 (CYP) 2C9
排除标准
- •Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
- •Any evidence of a clinically relevant concomitant disease
- •Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- •Surgery of the gastrointestinal tract (except appendectomy)
- •Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- •History of relevant orthostatic hypotension, fainting spells or blackouts
- •Chronic or relevant acute infections
- •History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
- •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 or that prolong the QT/QTc interval based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
- •Participation in another trial with an investigational drug within two months prior to administration or during the trial
- •Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
- •Inability to refrain from smoking on trial days
- •Alcohol abuse (more than 60 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
- •Inability to comply with dietary regimen of trial site
- •A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms)
- •A history of additional risk factors for Torsades de points (TdP) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
- •Exclusion criteria specific for this study:
- •Anemia at screening
- •Galactose intolerance
- •Lactase deficiency
- •Glucose-galactose-malabsorption
研究组 & 干预措施
Treatment B: BI 1356 and Warfarin
Experimental
BI 1356 for 12 days combined with a single dose of warfarin on day 6
干预措施: Warfarin (Drug)
Treatment B: BI 1356 and Warfarin
Experimental
BI 1356 for 12 days combined with a single dose of warfarin on day 6
干预措施: BI 1356 (Drug)
Treatment A: Warfarin
Active Comparator
Warfarin as single dose
干预措施: Warfarin (Drug)
结局指标
主要结局
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
时间窗: Up to 168 hours after start of study medication
Maximum measured concentration of the analyte in plasma (Cmax)
时间窗: Up to 168 hours after start of study medication
次要结局
- Terminal rate constant in plasma (λz)(Up to 168 hours after start of study medication)
- Apparent clearance of the analyte in the plasma after extravascular administration (CL/F)(Up to 168 hours after start of study medication)
- Number of patients with relevant changes in physical examination(Up to 14 days after last study drug administration)
- Number of patients with relevant changes in vital signs (Blood Pressure (BP), Pulse Rate (PR))(Up to 14 days after last study drug administration)
- Area under the concentration time curve (AUC) of the analyte in plasma at different time points(Up to 168 hours after start of study medication)
- Time from dosing to the maximum concentration of the analyte in plasma (tmax)(Up to 168 hours after start of study medication)
- Number of patients with adverse events(Up 42 days)
- Number of patients with relevant changes in laboratory values(Up to 14 days after last study drug administration)
- Terminal half life of the analyte in plasma (t1/2)(Up to 168 hours after start of study medication)
- Mean residence time of the analyte in the body after p.o. administration (MRTpo)(Up to 168 hours after start of study medication)
- Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F)(Up to 168 hours after start of study medication)
- Number of patients with relevant changes in 12-lead resting electrocardiogram (ECG)(Up to 14 days after last study drug administration)
- Prothrombin time, maximum concentration of the analyte in plasma (PTmax)(Up to 168 hours after start of treatment)
- Assessment of tolerability a 4-point scale by the investigator(Up 42 days)
- International normalised ratio, area under the concentration time curve of the analyte in plasma over the time interval from time zero to 168 hours (INR AUC0-168)(Up to 168 hours after start of treatment)
- International normalised ratio, maximum concentration of the analyte in plasma (INRmax)(Up to 168 hours after start of treatment)
- Prothrombin time, area under the concentration time curve of the analyte in plasma over the time interval from time zero to 168 hours (PT AUC0-168)(Up to 168 hours after start of treatment)
研究者
相似试验
已完成
1 期
Bioavailability of BI 1356 After Single Oral Administration Given as Different Tablet Formulation in Healthy Male VolunteersHealthyNCT02183363Boehringer Ingelheim24
已完成
1 期
A Study in Healthy Men to Test How Itraconazole Influences the Amount of BI 1358894 in the BloodHealthyNCT03843151Boehringer Ingelheim16
已完成
1 期
A Study in Healthy Men to Test How Itraconazole Influences the Amount of BI 1323495 in the BloodHealthyNCT04011241Boehringer Ingelheim14
已完成
1 期
A Study in Healthy Men to Test How Itraconazole Influences the Amount of BI 1291583 in the BloodHealthyNCT03890887Boehringer Ingelheim14
已完成
1 期
Safety, Tolerability, and Pharmacokinetics of a Subcutaneous and Intravenous Dose of BI 655130 in Healthy SubjectsHealthyNCT03100903Boehringer Ingelheim36