NCT02259894已完成1 期
Safety, Pharmacokinetics, and Pharmacodynamics of Single Rising Oral Doses of BIRT 2584 XX (5, 30, 100, 200, 350, 500, and 700 mg) as a Solution in PEG 400 Administered to Healthy Male Volunteers. Placebo Controlled and Blinded at Each Dose Level.
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
- 55
- 主要终点
- Number of participants with adverse events
研究概览
简要总结
To assess safety, tolerability, pharmacokinetics, and pharmacodynamics of BIRT 2584 XX in single rising oral doses of 5 mg to 700 mg in a polyethylene glycol 400 (PEG 400) solution in healthy subjects
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
- Double
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 as determined by results of screening
- •Signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
- •Age >=18 and <=50 years
- •BMI >=18.5 and <=29.9 kg/m2
排除标准
- •Any finding of the medical examination (including blood pressure, pulse rate, and electrocardiogram) deviating from normal and of clinical relevance
- •Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, haematological, oncological or hormonal disorders
- •Surgery of gastrointestinal tract (except appendectomy)
- •Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- •Relevant history of orthostatic hypotension, fainting spells or blackouts
- •Chronic or relevant acute infections
- •History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- •Intake of drugs with a long half-life (> 24 hours) (< 1 month prior to administration or during the trial)
- •Use of any drugs, which might influence the results of the trial, (< 10 days prior to study drug administration or expected during the trial)
- •Participation in another trial with an investigational drug (< 2 months prior to administration or expected during trial)
- •Smoker (> 10 cigarettes or >3 cigars or >3 pipes/day)
- •Alcohol abuse (> 60 g/day)
- •Drug abuse
- •Blood donation or loss > 400 mL, < 1 month prior to administration or expected during the trial
- •Clinically relevant laboratory abnormalities
- •Any ECG value outside of the reference range and of clinical relevance including, but not limited to QRS interval > 110 ms or QT interval, Bazett correction (QTcB) > 450 ms or QT interval >500 ms
- •Inability to comply with dietary regimen of study centre
- •Inability to comply with investigator's instructions
研究组 & 干预措施
BIRT 2584
Experimental
single rising doses
干预措施: BIRT 2584 XX (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Number of participants with adverse events
时间窗: Up to 16 days after drug administration
Number of participants with clinically significant changes in vital signs
时间窗: Up to 16 days after drug administration
Number of participants with abnormal changes in clinical laboratory parameters
时间窗: Up to 16 days after drug administration
Number of participants with abnormal findings in 12-lead ECG (electrocardiogram)
时间窗: Up to 16 days after drug administration
Number of participants with abnormal findings in physical examination
时间窗: Screening and up to 16 days after drug administration
次要结局
- Ae0-48 (amount of analyte that is eliminated in urine from 0-48 hours)(Up to 48 hours after drug administration)
- fe0-48 (fraction of analyte eliminated in urine from 0-48 hours)(Up to 48 hours after drug administration)
- CLR,0-48 (renal clearance of the analyte from 0-48 hours)(Up to 48 hours after drug administration)
- Cmax (maximum concentration in plasma)(Up to 360 hours after drug administration)
- tmax (time from dosing to maximum concentration)(Up to 360 hours after drug administration)
- AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time) interval from 0 extrapolated to infinity)(Up to 360 hours after drug administration)
- AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time) interval from 0 to the last quantifiable analyte plasma concentration)(Up to 360 hours after drug administration)
- λz (terminal rate constant in plasma)(Up to 360 hours after drug administration)
- t1/2 (terminal half-life of the analyte in plasma)(Up to 360 hours after drug administration)
- MRT(mean residence time of the analyte in the body)(Up to 360 hours after drug administration)
- CL/F (apparent oral clearance in plasma after oral administration)(Up to 360 hours after drug administration)
- Vz/F (apparent volume of distribution during the terminal phase λz) dose)(Up to 360 hours after drug administration)
- Receptor occupancy as determined by binding of anti-LFA-1 antibody fragment (Fab)(Up to 360 hours after drug administration)
- Inhibition of IL-2 production(Up to 360 hours after drug administration)
研究者
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