Single Center, Open-label, Non-randomized, Non-placebo-controlled Study to Investigate the Metabolism, Excretion Pattern, Mass Balance, Safety, Tolerability and Pharmacokinetics After Single Intravenous Administration of 12 mg [14C]Copanlisib (BAY 80-6946) in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 6
- 主要终点
- Metabolite profile in feces
研究概览
简要总结
The study aims to provide understanding of the relative relevance of the different excretion pathways of Copanlisib in humans, as well as to characterize its metabolite profile.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subject
- •Age: 45 to 65 years
- •Body weight greater or equal to 60 kg and body mass index (BMI): above/equal 18 and below/equal 30 kg/m²
排除标准
- •Regular use of medicines
- •Known recent (last 2 years) abuse of recreational drugs, suspicion of drug or alcohol abuse, or positive results of the drug and alcohol screen tests at screening or baseline
- •Use of strong inhibitors of cytochrome P450 (CYP)3A4, as well as use of St John's Wort or strong inducers of CYP3A4 prohibited from 14 days before the administration of study drug until discharge from the clinic
- •Average intake of more than 24 units of alcohol per week; Regular daily consumption of more than 1 L of methylxanthine-containing beverages
- •Any condition, which may result in longer than usual retention of urine or feces in the body, such as pronounced (less than one defecation in 2 days) constipation or symptomatic prostatic hypertrophy.
- •Participation in another mass balance study with a radiation burden > 0.1 mSv in the period of 1 year before screening
研究组 & 干预措施
[14C]Copanlisib
干预措施: Copanlisib (BAY80-6946) (Drug)
结局指标
主要结局
Metabolite profile in feces
时间窗: Multiple time points up to 336 hours
Pharmacokinetics of copanlisib in plasma by area under the measured matrix concentration versus time curve from the first time point (t=0) extrapolated to infinity (AUC)
时间窗: Multiple time points up to 336 hours
Pharmacokinetics of total radioactivity in whole blood by Cmax
时间窗: Multiple time points up to 336 hours
Pharmacokinetics of total radioactivity in whole blood by AUC(0-tlast)
时间窗: Multiple time points up to 336 hours
Pharmacokinetics of copanlisib in plasma by maximum concentration (Cmax)
时间窗: Multiple time points up to 336 hours
Pharmacokinetics of total radioactivity in whole blood by AUC
时间窗: Multiple time points up to 336 hours
Pharmacokinetics of copanlisib in plasma by area under the measured matrix concentration versus time curve to the last data point above the lower limit of quantitation (AUC(0-tlast))
时间窗: Multiple time points up to 336 hours
Pharmacokinetics of total radioactivity in plasma by Cmax
时间窗: Multiple time points up to 336 hours
Pharmacokinetics of total radioactivity in plasma by AUC
时间窗: Multiple time points up to 336 hours
Pharmacokinetics of total radioactivity in plasma by AUC(0-tlast)
时间窗: Multiple time points up to 336 hours
Radioactivity excreted in urine as a percentage of the dose (AE,ur)
时间窗: Multiple time points up to 336 hours
Radioactivity excreted in feces as a percentage of the dose (AE,fec)
时间窗: Multiple time points up to 336 hours
Metabolite profile in plasma
时间窗: Multiple time points up to 336 hours
Metabolite profile in urine
时间窗: Multiple time points up to 336 hours
次要结局
- Number of participants with adverse events as a measure of safety and tolerability(Until 30 days after study drug administration)