A Trial Investigating the Pharmacokinetic Properties of Insulin Icodec in Subjects With Various Degrees of Hepatic Impairment
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- AUC,Ico,0-inf,SD, Area under the serum insulin icodec concentration-time curve after a single dose
研究概览
简要总结
Participants will receive one insulin icodec dose, which will be administered in the morning of the day of dosing.
The study will last for about 8 weeks. Participants will have 8 visits with the study doctor in the clinical research unit.
Insulin icodec will be injected into a skin fold with a small needle (subcutaneous application) using a pen injector prefilled with a volume of 3 mL (about a spoonful).
Participants must not participate if they meet certain conditions called exclusion criteria, such as an age of below 18 years or above 70 years, if participants are over- or underweight, using certain medicines, or have serious health conditions (other than impaired liver function ).
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
- 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female
- •Aged 18-70 years (both inclusive) at the time of signing informed consent
- •Body mass index between 18.5 and 39.9 kg/m^2 (both inclusive) Specific inclusion criterion only for subjects with hepatic impairment
- •Subjects with stable hepatic impairment classified as Child-Pugh grade A, B or C as assessed by the investigator. Stable hepatic impairment is defined as no clinically significant change in disease status, as judged by the investigator.
排除标准
- •Known or suspected hypersensitivity to trial product or related products
- •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 measures as required by local regulation or practice)
- •Diagnosis of diabetes mellitus
研究组 & 干预措施
Subjects with moderate hepatic impairment, child-pugh grade B
The participants will be allocated into four groups. Receiving one insulin icodec dose, administered subcutaneously.
干预措施: Insulin icodec (Drug)
Subjects with normal hepatic function
The participants will be allocated into four groups. Receiving one insulin icodec dose, administered subcutaneously.
干预措施: Insulin icodec (Drug)
Subjects with mild hepatic impairment, child-pugh grade A
The participants will be allocated into four groups. Receiving one insulin icodec dose, administered subcutaneously.
干预措施: Insulin icodec (Drug)
Subjects with severe hepatic impairment, child-pugh grade C
The participants will be allocated into four groups. Receiving one insulin icodec dose, administered subcutaneously.
干预措施: Insulin icodec (Drug)
结局指标
主要结局
AUC,Ico,0-inf,SD, Area under the serum insulin icodec concentration-time curve after a single dose
时间窗: Day 1
From 0 hours until infinity after trial product administration (pmol\*h/L)
次要结局
- tmax,Ico,SD, Time to maximum observed serum insulin icodec concentration after a single dose(Day 1)
- Cmax,Ico,SD, Maximum observed serum insulin icodec concentration after a single dose(Day 1)