NCT02962440已完成1 期
A Single Centre, Open Label Trial Investigating the Absorption, Metabolism and Excretion of Somapacitan After Single Subcutaneous Dosing in Healthy Male Subjects
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
- 7
- 试验地点
- 1
- 主要终点
- Total amount of [3H]-somapacitan related material excreted in urine (% of dose)
研究概览
简要总结
This trial is conducted in Europe. The aim of the trial is to investigate the absorption, metabolism and excretion of somapacitan after single subcutaneous dosing in healthy male subjects.
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
- 45 Years 至 64 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male, aged 45-64 years (both inclusive) at the time of signing informed consent
- •Body mass index (BMI) 20.0-29.9 kg/m^2 (both inclusive)
- •Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator
排除标准
- •Male of reproductive age who or whose partner(s) is not willing to use adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice) for at least 4 months after dosing or male who is not willing to refrain from donating semen for at least 4 months after dosing. Acceptable forms of prevention include complete sexual abstinence, surgically sterilisation, that the subject uses a condom during intercourse or that the partner practices adequate contraception (risk of pregnancy must be lower than 1%).
- •Use of prescription or non-prescription products, including herbal products and non-routine vitamins, within 14 days prior to screening. Occasional use of paracetamol is permitted.
- •Any blood draw in excess of 25 mL in the past 30 days, or donation of blood or plasma in excess of 400 mL within the 90 days preceding screening.
研究组 & 干预措施
Somapacitan
Experimental
干预措施: somapacitan (Drug)
结局指标
主要结局
Total amount of [3H]-somapacitan related material excreted in urine (% of dose)
时间窗: Assessed up to 35 days after trial product administration
Total amount of [3H]-somapacitan related material excreted in faeces (% of dose)
时间窗: Assessed up to 35 days after trial product administration
Total amount of [3H]-somapacitan related material excreted in expired air (% of dose)
时间窗: Assessed up to 35 days after trial product administration
次要结局
- Total recovery of administered 3H label (sum of urine, faeces and expired air)(Assessed up to 36 days after trial product administration)
- Blood to plasma ratio of [3H]-somapacitan related material(Assessed up to 36 days after trial product administration)
研究者
研究点 (1)
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