NCT06006598已完成1 期
Safety, Tolerability, and Pharmacokinetics of Multiple Rising Oral Doses of BI 1584862 in Healthy Subjects (Single-blind, Randomised, Placebo-controlled, Parallel Group Design)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator
研究概览
简要总结
The main objectives of this trial are to investigate safety, tolerability, and pharmacokinetics of BI 1584862 in healthy male subjects following administration of multiple rising doses.
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 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)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
- •Age of 18 to 50 years (inclusive)
- •Body mass indey (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
- •Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
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 50 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 1584862 treatment arm
Experimental
干预措施: BI 1584862 (Drug)
Placebo arm
Placebo Comparator
干预措施: Placebo matching BI 1584862 (Drug)
BI 1584862 + midazolam treatment arm
Experimental
干预措施: midazolam (Drug)
结局指标
主要结局
Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator
时间窗: Up to 27 days
expressed as the percentage of subjects treated with investigational drug who experience such an event
次要结局
- Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmax,ss)(Up to 15 days)
- Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ (AUCτ,ss)(Up to 15 days)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Study in Healthy Men to Test How the Body Takes up and Tolerates Different Doses of BI 765080HealthyNCT04666922Boehringer Ingelheim48
已完成
1 期
A Study to Test How Well Healthy Men and Women Tolerate Different Doses of BI 706321NCT04241458Boehringer Ingelheim39
已完成
1 期
A Study to Test How Well Men Tolerate Different Doses of BI 3006337HealthyNCT05076422Boehringer Ingelheim80
终止
1 期
Single Rising Dose Study of BI 201335 ZW in Healthy Male SubjectsHealthyNCT02182271Boehringer Ingelheim8
已完成
1 期
A Study to Test How Well Multiple Doses of BI 765423 Are Tolerated by Healthy MenHealthyNCT06232252Boehringer Ingelheim38