NCT02259972已完成1 期
Investigation of Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of 5 to 800 mg BI 113823 Powder in Bottle (PiB) and Tablet Administered to Healthy Male Volunteers in a Partially Randomised and Double Blinded, Placebo Controlled Phase I Trial. Including Intra-individual Open Comparisons of PiB and Tablet (Fasted and Fed).
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
- 63
- 主要终点
- Number of participants with clinically significant findings in 12-lead electrocardiogram (ECG)
研究概览
简要总结
To investigate the safety, tolerability, and pharmacokinetics incl. dose proportionality of BI 113823, as well as the relative bioavailability of PiB vs. tablet and tablet fasted vs. fed (food effect for the tablet).
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 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 Age ≤45 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 GCP and the local legislation
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
- •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
- •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 30 g/day)
- •Blood donation (more than 100 mL within four weeks prior to administration)
- •Excessive physical activities (within one week prior to administration)
- •Any laboratory value outside the reference range that is of clinical relevance
- •Inability to comply with dietary regimen of trial site
- •Bradycardia < 50/min, PR interval > 200 ms, QRS interval > 110 ms, QTcB > 450 ms, or QT (uncorrected) > 470 ms or any other relevant ECG findings at screening
- •A history of additional risk factors for Torsades des Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
研究组 & 干预措施
BI 113823 tablet
Experimental
dose group 5 only
干预措施: BI 113823 tablet (Drug)
BI 113823 solution
Experimental
single rising doses, dose group 5 twice (fed and fasted)
干预措施: BI 113823 solution (Drug)
BI 113823 solution
Experimental
single rising doses, dose group 5 twice (fed and fasted)
干预措施: High fat, high calorie breakfast (Other)
BI 113823 tablet
Experimental
dose group 5 only
干预措施: High fat, high calorie breakfast (Other)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Number of participants with clinically significant findings in 12-lead electrocardiogram (ECG)
时间窗: up to 14 days after last drug administration
special attention to QRS prolongation
Number of participants with clinically significant findings in vital signs
时间窗: up to 14 days after last drug administration
blood pressure (BP), pulse rate (PR)
Number of participants with adverse events
时间窗: up to 14 days after last drug administration
Assessment of tolerability by investigator on a 4-point scale
时间窗: up to 14 days after last drug administration
Number of participants with clinically significant findings in laboratory tests
时间窗: up to 14 days after last drug administration
Number of participants with clinically significant findings on physical examination
时间窗: up to 14 days after last drug administration
次要结局
- λz (terminal rate constant in plasma)(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 72 hours after drug administration)
- AUC0-∞ (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)
- AUC0-tz (area under the concentration-time curve of metformin in plasma over the time interval from 0 to the time of the last quantifiable data point)(up to 72 hours after drug administration)
- t1/2 (terminal half-life of the analyte in plasma)(up to 72 hours after drug administration)
- MRToral (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)
- Cmax (maximum measured concentration of the analyte in plasma)(up to 72 hours after drug administration)
- tmax (time from dosing to maximum measured concentration)(up to 72 hours after drug administration)
- CL/F (total/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 72 hours after drug administration)
- fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2)(up to 72 hours after drug administration)
研究者
相似试验
终止
1 期
Multiple Rising Dose of BI 1181181 Given Orally in Young Healthy Male and Elderly Healthy Male/Female VolunteersHealthyNCT02254161Boehringer Ingelheim36
已完成
1 期
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 14332 CL Powder in Healthy Male SubjectsHealthyNCT02211989Boehringer Ingelheim53
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
已完成
1 期
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 11634 Solution in Healthy Male VolunteersHealthyNCT02214914Boehringer Ingelheim56
已完成
1 期
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Doses of BI 1356 BS in Healthy Male VolunteersHealthyNCT02183298Boehringer Ingelheim36