NCT03082183已完成1 期
Effects of Rifampicin on the Pharmacokinetics of BI 425809 Following Oral Administration in Healthy Male Subjects (an Open-label, Two-period, Fixed-sequence Trial)
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
- 16
- 试验地点
- 1
- 主要终点
- Cmax (maximum measured concentration of BI 425809 in plasma)
研究概览
简要总结
The primary objective of this trial is to investigate the relative bioavailability of a single dose of BI 425809 when given alone (Reference, B) compared with co-administration (Test, A) on the 7th day of a 10-day treatment with rifampicin following oral administration in healthy male volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 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, based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests
- •Age of 18 to 55 years (incl.)
- •BMI of 18.5 to 29.9 kg/m2 (incl.)
- •Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation
排除标准
- •Any finding in the medical examination (including BP, PR or 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 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 judged as clinically relevant by the investigator
- •Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- •Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy and 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
- •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)
- •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 or during the trial
- •Inability to comply with dietary regimen of trial site
- •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
- •In addition, the following trial-specific exclusion criteria apply:
- •History of relevant liver diseases such as disturbance of liver function, jaundice, drug induced liver injury, Dubin-Johnson syndrome, Rotor syndrome, or liver tumours
- •Thrombocytes below lower limit of normal or liver enzymes (ALT, AST, GGT, AP) above upper limit of normal at the screening examination
研究组 & 干预措施
All participants
Experimental
BI 425809 given alone in first period, then in combination with Rifampicin in second period
干预措施: Rifampicin (Drug)
All participants
Experimental
BI 425809 given alone in first period, then in combination with Rifampicin in second period
干预措施: BI 425809 (Drug)
结局指标
主要结局
Cmax (maximum measured concentration of BI 425809 in plasma)
时间窗: up to 51 days
Cmax (maximum measured concentration of BI 425809 in plasma)
AUC0-168 (area under the concentration-time curve of BI 425809 in plasma over the time interval from 0 to 168 h)
时间窗: up to 168 hours
AUC0-168 (area under the concentration-time curve of BI 425809 in plasma over the time interval from 0 to 168 h)
次要结局
- AUC0-∞ (area under the concentration-time curve of BI 425809 in plasma over the time interval from 0 extrapolated to infinity)(up to 51 days)
- t1/2 (terminal half-life of BI 761036 in plasma)(up to 51 days)
研究者
研究点 (1)
Loading locations...
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