NCT02172209已完成1 期
The Effect of Food on the Bioavailability and Pharmacokinetics of BI 10773 Tablet, Administered as a Single Dose of 50 mg With and Without Food to Healthy Male Volunteers in an Open-label, Randomised Intraindividual Crossover Comparison Design
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
- 14
- 主要终点
- AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
研究概览
简要总结
Trial to assess the effect of food on the pharmacokinetics and the extent of absorption of a single dose BI 10773 tablet in healthy subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 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, HR), 12-lead ECG, clinical laboratory tests
- •Age ≥ 18 and Age ≤ 55 years
- •BMI ≥ 18.5 and BMI ≤ 29.9 kg/m2
- •Signed and dated written informed consent prior to admission to the study in accordance with GCP (Good Clinical Practice) and the local legislation
排除标准
- •Any finding in the medical examination (including BP (blood pressure), PR (pulse rate) and ECG (electrocardiogram)) 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 or 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 the 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 de pointes (e.g. heart failure, hypokalemia, family history of Long QT Syndrome)
- •Elevated urinary glucose levels at screening (> 15 mg/dl; > 0.83 mmol/L)
研究组 & 干预措施
BI 10773 tablet administered with food
Experimental
50 mg BI 10773 after a standardised high fat breakfast
干预措施: BI 10773 (Drug)
BI 10773 tablet administered to fasted subjects
Active Comparator
50 mg BI 10773 p.o. after an overnight fast of at least 10 hours
干预措施: BI 10773 (Drug)
结局指标
主要结局
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
时间窗: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours post dose
Cmax (maximum measured concentration of the analyte in plasma)
时间窗: Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours post dose
次要结局
- MRTpo (mean residence time of the analyte in the body after p.o. administration)(Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours post dose)
- tmax (time from dosing to the maximum concentration of the analyte in plasma)(Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours post dose)
- t1/2 (terminal half-life of the analyte in plasma)(Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours after last dose)
- %AUCtz-∞ (the percentage of the AUC0-∞ that is obtained by extrapolation)(Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours post dose)
- AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)(Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours post dose)
- λz (terminal rate constant in plasma)(Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours post dose)
- CL/F (apparent clearance of the analyte in the plasma after extravascular administration)(Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours post dose)
- Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)(Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours post dose)
- Glucose excretion in urine(pre-dose and 0-4, 4-8, 8-12, 12-24 hours post-dose)
- Changes from baseline in vital signs (blood pressure, pulse rate)(Baseline and within 14 days after last trial procedure)
- Changes from baseline in 12-lead ECG (electrocardiogram)(Baseline and within 14 days after last trial procedure)
- Creatinine excretion in urine(pre-dose and 0-4, 4-8, 8-12, 12-24 hours post-dose)
- Abnormal findings in physical examination(Baseline and within 14 days after last trial procedure)
- Changes from baseline in routine laboratory tests(Baseline and within 14 days after last trial procedure)
- Incidence of adverse events(Up to 15 days)
- Assessment of tolerability by investigator on a 4-point scale(Within 14 days after last trial procedure)
研究者
相似试验
已完成
1 期
Comparative Bioavailability Study of BIA 9-1067 25 mg CapsulesParkinsonNCT02071823Bial - Portela C S.A.12
已完成
不适用
A Multiple Dose Crossover Pharmacokinetics Study to Evaluate the Effects of Food on the Absorption of Oral GanciclovirCytomegalovirus InfectionsHIV InfectionsNCT00002251Hoffmann-La Roche20
已完成
1 期
The Tolerability and Effect of Food on the Pharmacokinetics of a Single 800 mg Oral Dose of BIA 2-093EpilepsyNCT02170649Bial - Portela C S.A.12
已完成
1 期
Relative Bioavailability and Food Effect Study of Losmapimod 15 mg TabletsHealthy Adult SubjectsNCT05002231Fulcrum Therapeutics18
已完成
1 期
Relative Bioavailability of BI 1015550 Following Oral Administration Under Fed and Fasted Conditions in Healthy Male SubjectsHealthyNCT03302078Boehringer Ingelheim12