NCT02183441已完成1 期
Relative Bioavailability of a Single Oral Dose of BI 1356 (5 mg) After Co-administration With Multiple Oral Doses of Ritonavir (200 mg Bid for 3 Days) Compared to the Bioavailability of a Single Oral Dose of BI 1356 (5 mg) Alone in Healthy Male Volunteers (an Open-label, Randomized, Two-way Crossover, 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
- 12
- 主要终点
- AUC0-24 (Area under the concentration-time curve of BI 1356 in plasma over the time interval from 0 to 24 hours)
研究概览
简要总结
Study to investigate the effect of the P-gp and cytochrome P450 (CYP) 3A4 inhibitor ritonavir on the pharmacokinetics of BI 1356
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 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
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 (e.g. HIV)
- •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 five 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 (especially unspecific inducing agents like St.John´s wort (Hypericum perforatum) or drugs which 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) or inability to stop alcoholic beverages for 24 hours prior to dosing and up to the last sampling time point
- •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 (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
- •Exclusion criteria specific for this study:
- •Galactose intolerance
- •Lactase deficiency
- •Glucose-galactose-malabsorption
研究组 & 干预措施
BI 1356 plus ritonavir
Experimental
Treatment A: 3 days of ritonavir, 1 day BI 1356
干预措施: BI 1356 (Drug)
BI 1356 plus ritonavir
Experimental
Treatment A: 3 days of ritonavir, 1 day BI 1356
干预措施: Ritonavir (Drug)
BI 1356
Active Comparator
Treatment B: BI 1356 alone
干预措施: BI 1356 (Drug)
结局指标
主要结局
AUC0-24 (Area under the concentration-time curve of BI 1356 in plasma over the time interval from 0 to 24 hours)
时间窗: up to 24 hours after start of treatment
Cmax (Maximum measured concentration of BI 1356 in plasma)
时间窗: up to 96 hours after start of treatment
次要结局
- AUC (Area under the concentration time curve of the analytes in plasma at different time points)(up to 96 hours after start of treatment)
- λz (Terminal rate constant of the analytes in plasma)(up to 96 hours after start of treatment)
- CL/F (Apparent clearance of BI 1356 in plasma after extravascular administration )(up to 96 hours after start of treatment)
- Number of patients with adverse events(up to 53 days)
- %AUCtz-∞ (Percentage of the extrapolated part of the area under the concentration time curve of the analytes in plasma from 0 to infinity)(up to 96 hours after start of treatment)
- tmax (Time from dosing to the maximum concentration of the analytes in plasma)(up to 96 hours after start of treatment)
- t1/2 (Terminal half-life of the analytes in plasma)(up to 96 hours after start of treatment)
- Aet1-t2 (Amount of the analytes that is eliminated in urine from the time interval t1 to t2)(up to 24 hours after start of treatment)
- Cmax (Maximum measured concentration of CD 1750 in Plasma)(up to 96 hours after start of treatment)
- MRTpo (Mean residence time in the body after po administration of the analytes in plasma)(up to 96 hours after start of treatment)
- Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose) of BI 1356(up to 96 hours after start of treatment)
- fet1-t2 (Fraction of BI 1356 excreted unchanged in urine from time point t1 to t2)(up to 24 hours after start of treatment)
- CLR,t1-t2 (Renal clearance of the analytes in plasma)(up to 24 hours after start of treatment)
研究者
相似试验
已完成
1 期
Relative Bioavailability of a Single-dose Administration of BIBW 2992 and Multiple-dose Administration of Ritonavir in Healthy VolunteersHealthyNCT02171754Boehringer Ingelheim22
已完成
1 期
Investigation of Ritonavir Effects on Afatinib Exposure in Healthy SubjectsHealthyNCT01426958Boehringer Ingelheim24
已完成
1 期
Relative Bioavailability Study of PF-07321332/Ritonavir Oral Powder Relative to the Commercial Tablets in Healthy ParticipantsBioavailabilityNCT05263921Pfizer12
已完成
1 期
Bioavailability of Tipranavir/Ritonavir Paediatric Solution Compared to Tipranavir/Ritonavir Capsules in Healthy Female and Male SubjectsHealthyNCT02251158Boehringer Ingelheim30
已完成
1 期
Relative Bioavailability Study of Nirmatrelvir/Ritonavir 4 Different Fixed Dose Combination Tablets Relative to the Commercial Tablets in Healthy ParticipantsBiological AvailabilityHealthy ParticipantsNCT05525910Pfizer15