NCT03186495已完成1 期
Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Doses of Somapacitan in Subjects With Various Degrees of Impaired Renal Function Compared to Subjects With Normal Renal Function
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
- 44
- 试验地点
- 1
- 主要终点
- Area under the somapacitan serum concentration time curve
研究概览
简要总结
The trial is conducted in Europe. The aim of the trial is to investigate the steady state exposure of somapacitan in subjects with various degrees of renal impairment (mild, moderate, severe renal impairment, requiring haemodialysis treatment) compared to subjects with normal renal function
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged 18-75 years (both inclusive) at the time of signing informed consent
- •Body mass index between 18.5-34.9 kg/sqm (both inclusive)
- •Meeting the pre-defined glomerular filtration rate for any of the renal function groups 1-4 (based on the measured glomerular filtration rate using exogenous sinistrin (Inutest®) as a filtration marker) or being in treatment with haemodialysis
排除标准
- •Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measure as required by local regulation or practice). Male of reproductive age who or whose partner(s) is not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice) or male who is not willing to refrain from donating semen for at least 16 days after last trial product administration
- •Any disorder, except for conditions associated with renal impairment in the groups of subjects with reduced renal function, which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol. For example, arterial hypertension, anaemia, impaired glucose tolerance or type 2 diabetes are accepted in the group of subjects with renal impairment
研究组 & 干预措施
Normal renal function
Experimental
Subjects with normal renal function
干预措施: Somapacitan (Drug)
Mild renal impairment
Experimental
Subjects with mild renal impairment
干预措施: Somapacitan (Drug)
Moderate renal impairment
Experimental
Subjects with moderate renal impairment
干预措施: Somapacitan (Drug)
Severe renal impairment
Experimental
Subjects with severe renal impairment
干预措施: Somapacitan (Drug)
Requiring haemodialysis treatment
Experimental
Subjects requiring haemodialysis treatment
干预措施: Somapacitan (Drug)
结局指标
主要结局
Area under the somapacitan serum concentration time curve
时间窗: From time 0 to 168 hours after the last dosing on Day 15.
Calculated based on the serum concentrations measured in ug/l
次要结局
- Incidence of adverse events(Day 0 - 43)
- Maximum serum concentration of somapacitan(After the last dosing on Day 15 up until Day 43)
- Time to maximum serum concentration of somapacitan(After the last dosing on Day 15 up until Day 43)
- Occurrence of anti-somapacitan antibodies(Day 0 - 43)
研究者
研究点 (1)
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