A Randomised, Open-label, Single-dose, Two-way Cross-over Relative Bioavailability Comparison of BI 1595043 as Tablets With and Without Food in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Maximum Measured Concentration of BI 1595043 in Plasma (Cmax)
研究概览
简要总结
The main objective of this trial is to investigate the relative bioavailability of BI 1595043 under fed state (Test, T) and under fasted state (Reference, R).
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 male 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), body temperature), 12-lead electrocardiogram (ECG), and clinical laboratory tests
- •Age of 18 to 50 years (inclusive)
- •Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
- •Signed and dated written informed consent prior to admission to the study, in accordance with GCP and local legislation
- •Male 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, i.e. use of condom (male subjects) plus any of the following methods (female partners): intrauterine device, hormonal contraception (e.g. implants, injectables, combined oral or vaginal contraceptives) that started at least 2 months prior to first drug administration to the male subject, or barrier method (e.g. diaphragm with spermicide), or surgically sterilised (including bilateral tubal occlusion, hysterectomy or bilateral oophorectomy), or postmenopausal, defined as at least 1 year of spontaneous amenorrhea
- •Sexually abstinent
- •Vasectomised (vasectomy at least 1 year prior to enrolment) in combination with a barrier method (i.e. condom) Unprotected sexual intercourse (i.e. without use of condom) with a pregnant female partner and sperm donation is not allowed throughout the study and until 30 days after trial completion
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 millimetre 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
- •History of relevant orthostatic hypotension, fainting spells, or blackouts
- •Further exclusion criteria apply
研究组 & 干预措施
BI 1595043 fasted (Reference (R)) / BI 1595043 fed (Test (T))
Two period crossover separated by a wash-out of at least 8 days:
Period 1: Healthy subjects received a single dose of 30 milligram (mg) BI 1595043 as film coated tablets (1x 5mg tablet and 1x 25mg tablet) following an overnight fast of at least 10 hours.
Period 2: Healthy subjects received a single dose of 30 milligram (mg) BI 1595043 as film coated tablets (1x 5mg tablet and 1x 25mg tablet) following an following a high fat/high calorie breakfast.
干预措施: BI 1595043 (Drug)
BI 1595043 fed (Test (T)) / BI 1595043 fasted (Reference (R))
Two period crossover separated by a wash-out of at least 8 days:
Period 1: Healthy subjects received a single dose of 30 milligram (mg) BI 1595043 as film coated tablets (1x 5mg tablet and 1x 25mg tablet) following an following a high fat/high calorie breakfast.
Period 2: Healthy subjects received a single dose of 30 milligram (mg) BI 1595043 as film coated tablets (1x 5mg tablet and 1x 25mg tablet) following an overnight fast of at least 10 hours.
干预措施: BI 1595043 (Drug)
结局指标
主要结局
Maximum Measured Concentration of BI 1595043 in Plasma (Cmax)
时间窗: Within 3 hours before drug administration and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 34, 48, 72, 96, 120, 144 and 168 hours following drug administration.
Maximum measured concentration of BI 1595043 in plasma (Cmax) is reported. The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. Data was logtransformed (natural logarithm) prior to fitting the ANOVA model.This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.
Area Under the Concentration-time Curve of BI 1595043 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
时间窗: Within 3 hours before drug administration and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 34, 48, 72, 96, 120, 144 and 168 hours following drug administration.
Area under the concentration-time curve of BI 1595043 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is reported. The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. Data was logtransformed (natural logarithm) prior to fitting the ANOVA model.This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.
次要结局
- Area Under the Concentration-time Curve of BI 1595043 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)(Within 3 hours before drug administration and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 34, 48, 72, 96, 120, 144 and 168 hours following drug administration.)