Relative Bioavailability of BI 1810631 as Two Different Oral Formulations Given as Single Doses and Investigation of the Effects of Food and Multiple-dose Rabeprazole on the Pharmacokinetics of Single-dose BI 1810631 Following Oral Administration in Healthy Male Subjects (an Open-label, Randomised, Four-way Crossover Trial)
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 1810631 in Plasma (Cmax)
研究概览
简要总结
BI 1810631 trial formulation 1 (TF1) is currently used in clinical trials, but is planned to be replaced by another formulation (principle) in future clinical trials and on the market. This trial intends to bridge pharmacokinetics (PK) between the two formulation principles. For this, relative bioavailability of TF1 and new formulation (NF) is assessed. Moreover the trial intends to inform on the effect of food and of the proton pump inhibitor rabeprazole on the PK of BI 1810631 after administration as NF in order to inform management of food and concomitant medications.
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 45 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)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests
- •Age of 18 to 45 years (inclusive)
- •Body mass index (BMI) of 18.5 to 29.9 weight divided by height squared (kg/m2) (inclusive)
- •Signed and dated written informed consent in accordance with International Council on Harmonisation - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
排除标准
- •Any finding in the medical examination (including blood pressure (BP), pulse rate (PR) or electrocardiogram (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
Treatment sequence 1: R - T1 - T2 - T3
Treatments:
R: TF1 fasted T1: NF fasted T2: NF fed T3: NF fasted + rabeprazole
干预措施: BI 1810631 - trial formulation 1 (TF1) (Drug)
Treatment sequence 1: R - T1 - T2 - T3
Treatments:
R: TF1 fasted T1: NF fasted T2: NF fed T3: NF fasted + rabeprazole
干预措施: BI 1810631 - new formulation (NF) (Drug)
Treatment sequence 1: R - T1 - T2 - T3
Treatments:
R: TF1 fasted T1: NF fasted T2: NF fed T3: NF fasted + rabeprazole
干预措施: Rabeprazole sodium (Drug)
Treatment sequence 2: T1 - T3 - R - T2
干预措施: BI 1810631 - trial formulation 1 (TF1) (Drug)
Treatment sequence 2: T1 - T3 - R - T2
干预措施: BI 1810631 - new formulation (NF) (Drug)
Treatment sequence 2: T1 - T3 - R - T2
干预措施: Rabeprazole sodium (Drug)
Treatment sequence 3: T2 - R - T3 - T1
干预措施: BI 1810631 - trial formulation 1 (TF1) (Drug)
Treatment sequence 3: T2 - R - T3 - T1
干预措施: BI 1810631 - new formulation (NF) (Drug)
Treatment sequence 3: T2 - R - T3 - T1
干预措施: Rabeprazole sodium (Drug)
Treatment sequence 4: T3 - T2 - T1 - R
干预措施: BI 1810631 - trial formulation 1 (TF1) (Drug)
Treatment sequence 4: T3 - T2 - T1 - R
干预措施: BI 1810631 - new formulation (NF) (Drug)
Treatment sequence 4: T3 - T2 - T1 - R
干预措施: Rabeprazole sodium (Drug)
结局指标
主要结局
Maximum Measured Concentration of BI 1810631 in Plasma (Cmax)
时间窗: Within 3 hours prior and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 34, 46, 70, 94 and 118 hours after BI 1810631 administration.
The maximum measured concentration of BI 1810631 in plasma (Cmax) was reported. Unit of geometric coefficient of variation (gCV) is %.
Area Under the Concentration-time Curve of BI 1810631 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
时间窗: Within 3 hours prior and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 34, 46, 70, 94 and 118 hours after BI 1810631 administration.
The area under the concentration-time curve of BI 1810631 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) was reported. Unit of geometric coefficient of variation (gCV) is %.
次要结局
- Area Under the Concentration-time Curve of BI 1810631 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)(Within 3 hours prior and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 34, 46, 70, 94 and 118 hours after BI 1810631 administration.)