NCT02254538已完成1 期
A Double-blind (at Each Dose Level), Randomised, Placebo-controlled Single Increasing Dose Safety, Tolerability and Preliminary Pharmacokinetics Study in Healthy Male Volunteers After Oral Administration of BILR 355 BS Solved in PEG 400 (Dosage: 1 - 200 mg)
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
- 54
- 主要终点
- Number of participants with clinically significant changes in vital functions
研究概览
简要总结
Assessment of safety, tolerability and preliminary pharmacokinetics in healthy male volunteers after oral administration of BILR 355 BS
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
- 21 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •All participants in the study should be healthy males, ranging from 21 to 50 years of age and their body mass index (BMI) be within 18.5 to 29.9 kg/m2 (BMI calculation: weight in kilograms divided by the square of height in meters).
- •In accordance with Good clinical practice (GCP) and the local legislation all volunteers will have given their written informed consent prior to admission to the study
排除标准
- •Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
- •Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- •Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- •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) within at least one month or less than ten half-lives of the respective drug before enrolment in the study or during the study
- •Use of any drugs which might influence the results of the trial up to 7 days prior to enrolment in the study or during the study
- •Participation in another trial with an investigational drug (≤ two months prior to administration or during the trial)
- •Smoker (> 10 cigarettes or > 3 cigars of > 3 pipes/day)
- •Inability to refrain from smoking on trial days
- •Alcohol abuse (> 60 g/day)
- •Drug abuse
- •Blood donation (≥ 100 mL within four weeks prior to administration or during the trial)
- •Any laboratory value outside the clinically accepted reference range
- •Excessive physical activities within the last week before the trial or during the trial
- •Following exclusion criteria are of special interest for this study:
- •Erythema, exanthema and comparable skin alterations
研究组 & 干预措施
BILR 355 BS
Experimental
escalating doses
干预措施: BILR 355 BS (Drug)
BILR 355 BS
Experimental
escalating doses
干预措施: PEG 400 (Drug)
Placebo
Placebo Comparator
干预措施: PEG 400 (Drug)
结局指标
主要结局
Number of participants with clinically significant changes in vital functions
时间窗: Up to 10 days after drug administration
Number of participants with abnormal findings in skin inspections
时间窗: Up to 10 days after drug administration
Number of participants with abnormal neurological finding
时间窗: Up to 10 days after drug administration
Number of participants with abnormal findings in ECG (electrocardiogram)
时间窗: Up to 10 days after drug administration
Number of participants with abnormal changes in laboratory parameters
时间窗: Up to 10 days after drug administration
Number of participants with positive faecal occult blood testing
时间窗: Up to 10 days after drug administration
Number of participants with adverse events
时间窗: Up to 10 days after drug administration
次要结局
- Time to attain maximum plasma concentration (tmax)(Up to 144 hours after drug administration)
- Terminal half life (t½)(Up to 144 hours after drug administration)
- Apparent clearance of the analyte in plasma following extravascular administration (CL/F)(Up to 144 hours after drug administration)
- Maximum plasma concentration (Cmax)(Up to 144 hours after drug administration)
- Area under the concentration-time curve of the analyte in plasma from zero time to infinity (AUC0-∞)(Up to 144 hours after drug administration)
- Apparent volume of distribution during the terminal elimination phase (Vz/F)(Up to 144 hours after drug administration)
- Amount of drug excreted in the urine (Ae)(Up to 72 hours after drug administration)
- Total mean residence time (MRTtot)(Up to 144 hours after drug administration)
- Area under the concentration-time curve of the analyte in plasma from zero time to the time of the last quantifiable drug concentration (AUC0-tz)(Up to 144 hours after drug administration)
- Renal clearance of the analyte (CLR)(Up to 72 hours after drug administration)
研究者
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