NCT04978506已完成1 期
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Rising Oral Doses of BI 1569912 (Single-blind, Partially Randomized Within Dose Groups, Placebo-controlled, Parallel Group Design) With an Optional Posology (Uptitration) Part (Single-blind, Partially Randomized Within Dose Groups, Placebo-controlled, Parallel Group Design) in Healthy Male Subjects
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- Percentage of subjects with drug-related adverse events
研究概览
简要总结
The main objectives of this trial are to investigate (1) safety, tolerability, pharmacokinetics and pharmacodynamics following multiple rising doses of BI 1569912; (2) tolerability of BI 1569912 in an up-titrating dosing scheme.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older 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
- •MRD- and POSO-part: Age of 18 to 45 years (inclusive); ELDERLY-part: Age of 65 to 80 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, e.g. any of the following methods (of female partners) plus condom: implants, injectables, combined oral or vaginal contraceptives, intrauterine device
- •Sexually abstinent
- •Surgically sterilised (including hysterectomy of female partner)
- •Postmenopausal female partner, defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with 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 millimetres of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 beats per minute (bpm)
- •Any laboratory value outside the reference range that the investigator considers to be of clinical relevance, in particular, hepatic parameters (alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin) or renal parameters (creatinine) exceeding the upper limit of normal (ULN) after repeated measurements
- •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/ convulsions or stroke), and other relevant neurological or psychiatric disorders
- •History of relevant orthostatic hypotension, fainting spells, or unexplained blackouts
结局指标
主要结局
Percentage of subjects with drug-related adverse events
时间窗: Up to Day 27
Number of Subjects With Drug-related Adverse Events
时间窗: Up to Day 27
Number of subjects with drug-related adverse events is reported.
次要结局
- Maximum measured concentration of the analyte in plasma after the first dose (Cmax)(At Day 1)
- Area under the concentration-time curve of the analyte in plasma over a uniform dosing interval of 24 h after administration of the first dose (AUC0-24)(At Day 1)
- Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmax,ss)(Up to Day 17)
- Minimum concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmin,ss)(Up to Day 17)
- Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ (AUCτ,ss)(Up to Day 17)
- Accumulation ratio based on Cmax,ss (RA,Cmax)(Up to Day 17)
- Accumulation ratio based on AUC0-τ (RA,AUC)(Up to Day 17)
- Area Under the Concentration-time Curve of BI 1569912 in Plasma Over a Uniform Dosing Interval of 24 h After Administration of the First Dose (AUC0-24)(Within 3 hours before first drug administration and at 15 minutes (min), 30 min, 45 min, 1 hour, 1 hour 15 min, 1 hour 30 min, 2 hours (hrs), 2 hrs 30 min, 3 hrs, 4 hrs, 6 hrs, 8 hrs, 10 hrs, 12 hrs, and 23 hrs after the first drug administration.)
- Maximum Measured Concentration of BI 1569912 in Plasma After the First Dose (Cmax)(Within 3 hours before first drug administration and at 15 minutes (min), 30 min, 45 min, 1 hour, 1 hour 15 min, 1 hour 30 min, 2 hours (hrs), 2 hrs 30 min, 3 hrs, 4 hrs, 6 hrs, 8 hrs, 10 hrs, 12 hrs, and 23 hrs after the first drug administration.)
- Area Under the Concentration-time Curve of BI 1569912 in Plasma at Steady State Over a Uniform Dosing Interval τ (AUCτ,ss) After the Last Dose(Within 1 hour before last drug administration and at 15 minutes (min), 30 min, 45 min, 1 hour, 1 hour 30 min, 2 hours (hrs), 2 hrs 30 min, 3 hrs, 4 hrs, 6 hrs, 8 hrs, 10 hrs, 12 hrs, 23 hrs, 47 hrs and 71 hrs after the last drug administration.)
- Maximum Measured Concentration of BI 1569912 in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmax,ss) After the Last Dose(Within 1 hour before last drug administration and at 15 minutes (min), 30 min, 45 min, 1 hour, 1 hour 30 min, 2 hours (hrs), 2 hrs 30 min, 3 hrs, 4 hrs, 6 hrs, 8 hrs, 10 hrs, 12 hrs, 23 hrs, 47 hrs and 71 hrs after the last drug administration.)
- Minimum Concentration of BI 1569912 in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmin,ss) After the Last Dose(Within 1 hour before last drug administration and at 15 minutes (min), 30 min, 45 min, 1 hour, 1 hour 30 min, 2 hours (hrs), 2 hrs 30 min, 3 hrs, 4 hrs, 6 hrs, 8 hrs, 10 hrs, 12 hrs, 23 hrs, 47 hrs and 71 hrs after the last drug administration.)
- Accumulation Ratio Based on Cmax,ss (RA,Cmax) After the Last Dose(Within 1 hour before last drug administration and at 15 minutes (min), 30 min, 45 min, 1 hour, 1 hour 30 min, 2 hours (hrs), 2 hrs 30 min, 3 hrs, 4 hrs, 6 hrs, 8 hrs, 10 hrs, 12 hrs, 23 hrs after the last administration on Day 1 and Day 14.)
- Accumulation Ratio Based on AUC0-τ (RA,AUC) After the Last Dose(Within 1 hour before last drug administration and at 15 minutes (min), 30 min, 45 min, 1 hour, 1 hour 30 min, 2 hours (hrs), 2 hrs 30 min, 3 hrs, 4 hrs, 6 hrs, 8 hrs, 10 hrs, 12 hrs, 23 hrs after the last administration on Day 1 and Day 14.)
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