Safety, Tolerability and Pharmacokinetics of BI 44370 TA Oral Drinking Solution in Healthy Male Volunteers (Dose Range: 5 - 800 mg). A Double-blind (Within Dose Groups), Randomised, Placebo-controlled Within Dose Groups, Single Rising Dose Study, Including Re-dosing at 100 mg and 500 mg (Solution) and at 200 mg (Four 50 mg Tablets)

Boehringer Ingelheim0 个研究点目标入组 56 人开始时间: 2007年4月最近更新: 2014年8月13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: 56
主要终点: Number of patients with adverse events

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

To evaluate the safety, tolerability and pharmacokinetics of single rising oral doses of BI 44370 TA in healthy male volunteers, to compare a drinking solution vs. a tablet formulation and to assess intra-individual pharmacokinetic (PK) variability by re-dosing two further doses.

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, RR and body temperature), 12-lead ECG, clinical laboratory tests
•Age ≥21 and Age ≤50 years
•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

•Any finding of the medical examination (including Blood Pressure (BP), Pulse Rate (PR), Respiratory rate (RR) , body temperature and Electrocardiogram(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) 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 44370 TA solution

Experimental

干预措施: BI 44370 TA solution (Drug)

BI 44370 TA tablet

Experimental

干预措施: BI 44370 TA tablet (Drug)

Placebo solution

Placebo Comparator

干预措施: Placebo solution (Drug)

Placebo tablet

Placebo Comparator

干预措施: Placebo tablet (Drug)