Relative Bioavailability, Safety, and Tolerability Following Subcutaneous Injection of Different Doses of BI 655130 and Different Injection Sites in Healthy Male and Female Subjects (a Single Dose, Mono-centric, Open-label Study in Matched-group Design).
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Area Under the Concentration-time Curve of BI 655130 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
研究概览
简要总结
The primary objective of this trial is to investigate the relative bioavailability of BI 655130 administered as two subcutaneous injections in the left and right periumbilical region compared to a single subcutaneous periumbilical injection of BI 655130.
The secondary objective is to investigate the relative bioavailability of a single subcutaneous injection of BI 655130 into the thigh compared to a single subcutaneous periumbilical injection of BI 655130.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 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 investigator's assessment, 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 50 years (incl.)
- •Body mass index (BMI) of 19.0 to 29.9 kg/m2 (incl.)
- •Signed and dated written informed consent prior to admission to the study in accordance with International Conference on Harmonisation - Good Clinical Practice (ICH-GCP) and local legislation
- •Male subjects, or female subjects who meet any of the following criteria starting from at least 30 days before the first administration of trial medication and 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)
- •Postmenopausal, defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous levels of FSH above 40 IU/L and estradiol below 30 ng/L is confirmatory)
排除标准
- •Any finding in the medical examination (including Blood pressure (BP), Pulse rate (PR) or Electrocardiogram (ECG)) is deviating from normal and judged 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 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 judged as clinically relevant by the investigator
- •Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- •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
- •Chronic or relevant acute infections
- •History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients)
- •Use of drugs within 30 days prior to administration of trial medication if that might reasonably influence the results of the trial (incl. QT/QTc interval prolongation)
- •Participation in another trial where an investigational drug has been administered within 60 days prior to planned administration of trial medication, or current participation in another trial involving administration of investigational drug
- •Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)
- •Inability to refrain from smoking on specified trial days
- •Alcohol abuse (consumption of more than 20 g per day for females and 30 g per day for males)
- •Drug abuse or positive drug screening
- •Blood donation of more than 100 mL within 30 days prior to administration of trial medication or intended donation during the trial
- •Intention to perform excessive physical activities within one week prior to administration of trial medication up to 4 weeks after administration
- •Inability to comply with dietary regimen of trial site
- •A marked baseline prolongation of QT/QTc interval (such as QTc intervals that are repeatedly greater than 450 ms in males or repeatedly greater than 470 ms in females) or any other relevant ECG finding at screening
- •A history of additional risk factors for Torsades de Pointes (such as heart failure, hypokalemia, or family history of Long QT Syndrome)
- •Subject is assessed as unsuitable for inclusion by the investigator, for instance, because considered not able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study
- •Female subjects will not be allowed to participate if any of the following applies:
- •Positive pregnancy test, pregnancy or plans to become pregnant up to study completion
- •Lactation
- •In addition, the following trial-specific exclusion criterion applies:
- •- Previous use of the trial medication
研究组 & 干预措施
R - Low dose of BI 655130 Periumbilical
Single low dose of BI 655130 administered as one single subcutaneous injection (given as 1 x 2 milliliter (mL)) in the periumbilical region following an overnight fast of at least 10 hours.
干预措施: R - Low dose of BI 655130 (Drug)
T1 - Low dose of BI 655130 Periumbilical (left and right)
Single low dose of BI 655130 administered as two single subcutaneous injections (given as 2 x 1 milliliter (mL)) in the periumbilical region (left and right) following an overnight fast of at least 10 hours.
干预措施: T1 - Low dose of BI 655130 (Drug)
T2 - Low dose of BI 655130 Thigh
Single low dose of BI 655130 administered as one single subcutaneous injection (given as 1 x 2 milliliter (mL)) in the thigh region following an overnight fast of at least 10 hours.
干预措施: T2 - Low dose of BI 655130 (Drug)
T3 - High dose of BI 655130 Periumbilical (left and right)
Single high dose of BI 655130 administered as two single subcutaneous injections (given as 2 x 2 milliliter (mL)) in the periumbilical region (left and right) following an overnight fast of at least 10 hours.
干预措施: T3 - High dose of BI 655130 (Drug)
结局指标
主要结局
Area Under the Concentration-time Curve of BI 655130 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
时间窗: Within 3 hours (h) before and 2, 3, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2184, 2856, 3528 and 4200 hours following administration of the trial drug.
Area under the concentration-time curve of BI 655130 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). Participants assigned to the Test Treatment Groups T1 and T2 were matched for gender and body weight (±10%) to participants assigned to Reference Treatment Group R.
Area Under the Concentration-time Curve of BI 655130 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz), Dose-Normalized
时间窗: Within 3 hours (h) before and 2, 3, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2184, 2856, 3528 and 4200 hours following administration of the trial drug.
Area under the concentration-time curve of BI 655130 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz), dose-normalized. Participants assigned to the Test Treatment Group T3 were matched for gender and body weight (±10%) to participants assigned to Reference Treatment Group R. mL = milliliter, mg = milligram.
Maximum Measured Concentration of BI 655130 in Plasma (Cmax)
时间窗: Within 3 hours (h) before and 2, 3, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2184, 2856, 3528 and 4200 hours following administration of the trial drug.
Maximum measured concentration of BI 655130 in plasma (Cmax). Participants assigned to the Test Treatment Groups T1 and T2 were matched for gender and body weight (±10%) to participants assigned to Reference Treatment Group R.
Maximum Measured Concentration of BI 655130 in Plasma (Cmax), Dose-Normalized
时间窗: Within 3 hours (h) before and 2, 3, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2184, 2856, 3528 and 4200 hours following administration of the trial drug.
Maximum measured concentration of BI 655130 in plasma (Cmax), dose-normalized. Participants assigned to the Test Treatment Group T3 were matched for gender and body weight (±10%) to participants assigned to Reference Treatment Group R.
次要结局
- Area Under the Concentration-time Curve of BI 655130 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)(Within 3 hours (h) before and 2, 3, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2184, 2856, 3528 and 4200 hours following administration of the trial drug.)
- Area Under the Concentration-time Curve of BI 655130 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞), Dose-Normalized(Within 3 hours (h) before and 2, 3, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2184, 2856, 3528 and 4200 hours following administration of the trial drug.)