The Effect of BI 730357 on the Pharmacokinetics of Rosuvastatin, Digoxin, Metformin and Furosemide Given as a Cocktail - an Open-label, Non-randomised, 2-period Fixed-sequence Trial in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Area Under the Concentration-time Curve of Metformin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞, Metformin)
研究概览
简要总结
The main objective of this trial is to investigate the effect of BI 730357 under steady state conditions on the pharmacokinetics of digoxin, furosemide, metformin and rosuvastatin given as a cocktail (Reference, R: cocktail alone; Test T: cocktail given under steady state conditions of BI 730357).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (Blood pressure (BP), Pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory Tests
- •Age of 18 to 55 years (inclusive)
- •BMI of 18.5 to 29.9 kilogram per square meter (kg/m2) (inclusive)
- •Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation
- •Male subjects, or female subjects who meet any of the following criteria from at least 30 days before the first administration of trial medication until 30 days after trial completion: -- Use of adequate contraception, e.g. any of the following methods plus condom: implants, injectables, combined oral or vaginal contraceptives, intrauterine device
- •Sexually abstinent
- •A vasectomised sexual partner (vasectomy at least 1 year prior to enrolment)
- •Surgically sterilised (including hysterectomy or bilateral tubal occlusion)
- •Postmenopausal, defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with levels of Follicle-stimulating hormone (FSH) above 40 units per liter (U/L) and estradiol below 30 nanograms per liter (ng/L) is confirmatory)
排除标准
- •Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
- •Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetres of Mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 beats per minute (bpm)
- •Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
- •Any evidence of a concomitant disease assessed as clinically relevant by the investigator
- •Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- •Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
- •Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
- •During COVID-19 pandemic: laboratory test indicative of an ongoing SARS-CoV-2 infection
- •further exclusion criteria apply
研究组 & 干预措施
Cocktail/ Cocktail + BI 730357
Cocktail treatment will be followed by the Test treatment in a fixed sequence. The treatment periods are separated by a wash-out phase of at least 14 days between the two cocktail administrations.
干预措施: BI 730357 (Drug)
Cocktail/ Cocktail + BI 730357
Cocktail treatment will be followed by the Test treatment in a fixed sequence. The treatment periods are separated by a wash-out phase of at least 14 days between the two cocktail administrations.
干预措施: CRESTOR® (Drug)
Cocktail/ Cocktail + BI 730357
Cocktail treatment will be followed by the Test treatment in a fixed sequence. The treatment periods are separated by a wash-out phase of at least 14 days between the two cocktail administrations.
干预措施: Lenoxin® (Drug)
Cocktail/ Cocktail + BI 730357
Cocktail treatment will be followed by the Test treatment in a fixed sequence. The treatment periods are separated by a wash-out phase of at least 14 days between the two cocktail administrations.
干预措施: MetfoLiquid GeriaSan® (Drug)
Cocktail/ Cocktail + BI 730357
Cocktail treatment will be followed by the Test treatment in a fixed sequence. The treatment periods are separated by a wash-out phase of at least 14 days between the two cocktail administrations.
干预措施: Lasix® (Drug)
结局指标
主要结局
Area Under the Concentration-time Curve of Metformin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞, Metformin)
时间窗: 2 hours (h) before and at 20 minutes (min), 40min, 1h, 1h30min, 2h, 2h30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 71h, 95h after administration of Metformin in both periods plus at 143h in period 1 and at 119h and 167h in period 2.
Area under the concentration-time curve of Metformin in plasma over the time interval from 0 extrapolated to infinity is reported. The geometric mean is actually adjusted geometric mean.
Area Under the Concentration-time Curve of Rosuvastatin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞, Rosuvastatin)
时间窗: 2 hours (h) before and at 20 minutes (min), 40min, 1h, 1h30min, 2h, 2h30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 71h, 95h after administration of Rosuvastatin in both periods plus at 143h in period 1 and at 119h and 167h in period 2.
Area under the concentration-time curve of Rosuvastatin in plasma over the time interval from 0 extrapolated to infinity is reported. The geometric mean is actually adjusted geometric mean.
Area Under the Concentration-time Curve of Furosemide in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞, Furosemide)
时间窗: 2 hours (h) before and at 20 minutes (min), 40min, 1h, 1h30min, 2h, 2h30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 71h, 95h after administration of Furosemide in both periods plus at 143h in period 1 and at 119h and 167h in period 2.
Area under the concentration-time curve of Furosemide in plasma over the time interval from 0 extrapolated to infinity is reported. The geometric mean is actually adjusted geometric mean.
Area Under the Concentration-time Curve of Digoxin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞, Digoxin)
时间窗: 2 hours (h) before and at 20 minutes (min), 40min, 1h, 1h30min, 2h, 2h30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 71h, 95h after administration of Digoxin in both periods plus at 143h in period 1 and at 119h and 167h in period 2.
Area under the concentration-time curve of Digoxin in plasma over the time interval from 0 extrapolated to infinity is reported. The geometric mean is actually adjusted geometric mean.
Maximum Measured Concentration of Metformin in Plasma (Cmax, Metformin)
时间窗: 2 hours (h) before and at 20 minutes (min), 40min, 1h, 1h30min, 2h, 2h30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 71h, 95h after administration of Metformin in both periods plus at 143h in period 1 and at 119h and 167h in period 2.
Maximum measured concentration of Metformin in plasma is reported. The geometric mean is actually adjusted geometric mean.
Maximum Measured Concentration of Rosuvastatin in Plasma (Cmax, Rosuvastatin)
时间窗: 2 hours (h) before and at 20 minutes (min), 40min, 1h, 1h30min, 2h, 2h30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 71h, 95h after administration of Rosuvastatin in both periods plus at 143h in period 1 and at 119h and 167h in period 2.
Maximum measured concentration of Rosuvastatin in plasma is reported. The geometric mean is actually adjusted geometric mean.
Maximum Measured Concentration of Furosemide in Plasma (Cmax, Furosemide)
时间窗: 2 hours (h) before and at 20 minutes (min), 40min, 1h, 1h30min, 2h, 2h30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 71h, 95h after administration of Furosemide in both periods plus at 143h in period 1 and at 119h and 167h in period 2.
Maximum measured concentration of Furosemide in plasma is reported. The geometric mean is actually adjusted geometric mean.
Maximum Measured Concentration of Digoxin in Plasma (Cmax, Digoxin)
时间窗: 2 hours (h) before and at 20 minutes (min), 40min, 1h, 1h30min, 2h, 2h30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 71h, 95h after administration of Digoxin in both periods plus at 143h in period 1 and at 119h and 167h in period 2.
Maximum measured concentration of Digoxin in plasma is reported. The geometric mean is actually adjusted geometric mean.
次要结局
- Area Under the Concentration-time Curve of Metformin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz, Metformin)(2 hours (h) before and at 20 minutes (min), 40min, 1h, 1h30min, 2h, 2h30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 71h, 95h after administration of Metformin in both periods plus at 143h in period 1 and at 119h and 167h in period 2.)
- Area Under the Concentration-time Curve of Rosuvastatin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz, Rosuvastatin)(2 hours (h) before and at 20 minutes (min), 40min, 1h, 1h30min, 2h, 2h30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 71h, 95h after administration of Rosuvastatin in both periods plus at 143h in period 1 and at 119h and 167h in period 2.)
- Area Under the Concentration-time Curve of Furosemide in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz, Furosemide)(2 hours (h) before and at 20 minutes (min), 40min, 1h, 1h30min, 2h, 2h30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 71h, 95h after administration of Furosemide in both periods plus at 143h in period 1 and at 119h and 167h in period 2.)
- Area Under the Concentration-time Curve of Digoxin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz, Digoxin)(2 hours (h) before and at 20 minutes (min), 40min, 1h, 1h30min, 2h, 2h30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 71h, 95h after administration of Digoxin in both periods plus at 143h in period 1 and at 119h and 167h in period 2.)