Safety, Tolerability and Pharmacokinetics of BI 34021 FU2 Oral Drinking Solution in Healthy Male Volunteers (Dose Range: 5 - 500 mg). A Double-blind (Within Dose Groups), Randomised, Placebo-controlled Within Dose Groups, Single Rising Dose Study, Including Re-dosing at 50 mg and 150 mg (Food Effect) and at 100 mg (Two 50 mg Tablets)

Boehringer Ingelheim0 个研究点目标入组 63 人开始时间: 2008年3月最近更新: 2014年10月9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: 63
主要终点: Number of participants with clinically significant findings on physical examination

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

Evaluation of safety, tolerability and PK of single rising oral doses of BI 34021 FU2 in healthy male volunteers; comparison of 100 mg drinking solution vs. tablet, assessment of food effect by re-dosing at 50 mg and 150 mg

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: 21 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 ≥21 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 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 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)
•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 Torsade des Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
•Not willing to use adequate contraception (condom use plus another form of contraception e.g. spermicide, oral contraceptive taken by female partner, sterilisation, intrauterine device (IUD) during the whole study period from the time of the first intake of study drug until three months after the last intake

研究组 & 干预措施

BI 34021 FU2 solution

Experimental

single rising doses, dose groups 3 and 5 double-dosing (fed and fasted)

干预措施: BI 34021 FU2 solution (Drug)

BI 34021 FU2 solution

Experimental

single rising doses, dose groups 3 and 5 double-dosing (fed and fasted)

干预措施: High fat, high calorie breakfast (Other)

BI 34021 FU2 tablet

Experimental

dose group 4 only

干预措施: BI 34021 FU2 tablet (Drug)

Placebo

Placebo Comparator

干预措施: Placebo (Drug)