Relative Bioavailability of Two Different Tablet Formulations of BI 1358894 Administered in Healthy Subjects in Fasted and Fed State (an Open-label, Randomised, Single-dose, Four-period, Four-sequence Crossover Study)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Area Under the Concentration-time Curve of BI 1358894 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
研究概览
简要总结
To investigate the relative bioavailability of the intended Commercial Formulation (iCF) (Test, T) compared with Trial Formulation 2 (TFII) (Reference, R) and to assess potential food effects following oral administration of BI 1358894.
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
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female 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)
- •Body mass index (BMI) of 18.5 to 29.9 kg/m^2 (inclusive)
- •Signed and dated written informed consent in accordance with International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
- •Either male subject, or female subject who meet any of the following criteria for a highly effective contraception from at least 30 days before administration of trial medication until 30 days after trial completion:
- •Use of combined (estrogen and progestogen containing) hormonal contraception that prevents ovulation (oral, intravaginal or transdermal), plus one additional barrier
- •Use of progestogen-only hormonal contraception that inhibits ovulation (only injectables or implants), plus one additional barrier
- •Use of intrauterine device (IUD) or intrauterine hormone-releasing system (IUS), plus one additional barrier
- •Sexually abstinent
- •A vasectomised sexual partner who received medical assessment of the surgical success (documented absence of sperm) and provided that partner is the sole sexual partner of the trial participant plus one additional barrier
- •Bilateral tubal ligation plus one additional barrier
- •Surgically sterilised (including hysterectomy, bilateral salpingectomy, bilateral oophorectomy)
- •Postmenopausal, defined as no menses for 1 year without an alternative medical cause (in questionable cases a blood sample with levels of Follicle-stimulating hormone (FSH) above 40 U/L and estradiol below 30 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 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 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 1358894 - test - fasted
A single dose of 100 mg (milligram) BI 1358894 given orally as a film-coated tablet in the morning following an overnight fast of at least 10 hours.
干预措施: BI 1358894, intended Commercial Formulation (iCF) (T) (Drug)
BI 1358894 - test - fed
A single dose of 100 mg (milligram) BI 1358894 given orally as a film-coated tablet in the morning following a high-fat, high-calorie meal.
干预措施: BI 1358894, intended Commercial Formulation (iCF) (T) (Drug)
BI 1358894 - reference - fasted
A single dose of 100 mg (milligram) BI 1358894 given orally as two 50 mg film-coated tablets in the morning following an overnight fast of at least 10 hours.
干预措施: BI 1358894, Trial Formulation 2 (TFII) (R) (Drug)
BI 1358894 - reference - fed
A single dose of 00 mg (milligram) BI 1358894 given orally as two 50 mg film-coated tablets in the morning following a high-fat, high-calorie meal.
干预措施: BI 1358894, Trial Formulation 2 (TFII) (R) (Drug)
结局指标
主要结局
Area Under the Concentration-time Curve of BI 1358894 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
时间窗: Within 3 hours before and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 34, 48, 72, 96, 120, 144, 240 and 312 hours following drug administration in each treatment period.
Area under the concentration-time curve of BI 1358894 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz).
Maximum Measured Concentration of BI 1358894 in Plasma (Cmax)
时间窗: Within 3 hours before and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 34, 48, 72, 96, 120, 144, 240 and 312 hours following drug administration in each treatment period.
Maximum measured concentration of BI 1358894 in plasma (Cmax).
次要结局
- Area Under the Concentration-time Curve of BI 1358894 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)(Within 3 hours before and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 34, 48, 72, 96, 120, 144, 240 and 312 hours following drug administration in each treatment period.)