A Randomised, Double-blind, Single Dose, Three Period, Complete Cross Over Trial in Healthy Subjects Investigating the Pharmacokinetics of Subcutaneous Injections of Somapacitan 5 mg/1.5 mL and 10 mg/1.5 mL
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Area under the somapacitan serum concentration time curve from time 0 to the time of the last quantifiable concentration after dosing
研究概览
简要总结
This study will compare two strengths of the new long-acting growth hormone somapacitan. The aim of this study is to test if both strengths are taken up in the blood in the same way. During three separate dosing visits participants will get a total of 3 injections of the study medicine. Somapacitan is not yet approved and therefore cannot be prescribed by a doctor outside of this study. The study duration is between 10 and 15 weeks. Participants will have 17 visits with the study doctor. Three visits will each comprise 6 in-house days with overnight stays. In total, at least 15 overnight stays at the clinic. There will be blood samplings during the study. Participants must come to the clinic regularly for these blood samplings. People who have already received growth hormones in the past or who are growth hormone deficient cannot be in the study. People cannot be in the study if the study doctor thinks that there are risks for their health. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female, aged 18-45 years (both inclusive) at the time of signing informed consent.
- •Body mass index (BMI) between 18.5 and 24.9 kg/m^2 (both inclusive).
- •Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG) and clinical laboratory tests performed during the screening visit, as judged by the investigator.
排除标准
- •Participation in any clinical trial of an approved or non-approved investigational medicinal product within 45 days or 5 times the half-life of the previous investigational medicinal product, whichever is longer, before screening.
- •Body weight above 100.0 kg
- •Subject with any known history of growth hormone deficiency as declared by the subject.
- •Subject who is non-naïve to growth hormone treatment as declared by the subject.
研究组 & 干预措施
Somapacitan 5/10/10 mg
One dose of somapacitan 5 mg/1.5 ml followed by two doses of somapacitan 10 mg/1.5 ml. Each dose will be followed by a 3 week observation period.
干预措施: somapacitan (Drug)
Somapacitan 10/5/10 mg
One dose of somapacitan 10 mg/1.5 ml followed by a 5 mg/1.5 ml dose followed by a 10 mg/1.5 ml dose. Each dose will be followed by a 3 week observation period.
干预措施: somapacitan (Drug)
Somapacitan 10/10/5 mg
Two doses of 10 mg/1.5 ml somapacitan followed by a 5 mg/1.5 ml dose. Each dose will be followed by a 3 week observation period.
干预措施: somapacitan (Drug)
结局指标
主要结局
Area under the somapacitan serum concentration time curve from time 0 to the time of the last quantifiable concentration after dosing
时间窗: 0 to 504 hours after trial product administration
ng\*h/mL
Maximum serum concentration of somapacitan
时间窗: 0 to 504 hours after trial product administration
ng/mL
次要结局
- Area under the somapacitan serum concentration time curve from time 0 to 168 hours after dosing(0 to 168 hours after trial product administration)
- Area under the somapacitan serum concentration time curve from time 0 to infinity(0 to 504 hours after trial product administration)
- Time to maximum serum concentration of somapacitan(0 to 504 hours after trial product administration)
- Terminal half-life of somapacitan(0 to 504 hours after trial product administration)
- Area under the insulin-like growth factor I (IGF-I) serum concentration time curve from time 0 to 168 hours after dosing(0 to 168 hours after trial product administration)
- Maximum serum concentration of IGF-I after dosing(0 to 504 hours after trial product administration)
- Time to maximum serum concentration of IGF-I after dosing(0 to 504 hours after trial product administration)