NCT06370819已完成1 期
Investigation of the Effect of Impaired Renal Function on the Pharmacokinetics of Subcutaneously Administered NNC0519-0130 in Participants With Various Degrees of 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
- 36
- 试验地点
- 1
- 主要终点
- Area under the curve (AUC)0-∞,NNC0519-0130,SD: Area under the NNC0519-0130 plasma concentration-time curve after a single dose in participants with normal function, and mild, moderate and severe impairment
研究概览
简要总结
NNC0519-0130 is a new medicine to improve the treatment options for people living with type 2 diabetes and people with overweight. In this study one dose of NNC0519-0130 will be given and blood levels of NNC0519-0130 will be compared between people with reduced kidney function and people with normal kidney function. The study will last up to 52 days including a screening phase of up to 28 days prior to dosing.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female of non-childbearing potential, aged 18-75 years (both inclusive) at the time of signing the informed consent.
- •Body mass index (BMI) between 20.0 and 39.9 kilogram per square metre (kg/m^2) (both inclusive) at screening.
- •Meeting the pre-defined glomerular filtration rate (GFR) criteria using estimated GFR (eGFR) based on the chronic kidney disease epidemiology collaboration (CKD-EPI) Creatinine Equation (2021) adjusted for estimated individual body surface area (BSA) for any of the renal function groups:
- •For participants with normal renal function: eGFR of greater than or equal to 90 millilitres per minute (mL/min)
- •Stage 2: For participants with mild renal impairment: eGFR of 60-89 mL/min
- •Stage 3: For participants with moderate renal impairment: eGFR of 30-59 mL/min
- •Stage 4: For participants with severe renal impairment: eGFR of 15-29 mL/min not requiring dialysis
- •Stage 5: For participants with kidney failure: eGFR of less than 15 mL/min and requiring dialysis treatment
排除标准
- •Any disorder which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
- •Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions (except conditions associated with renal impairment or kidney failure) as judged by the investigator.
- •Use of drugs known to affect creatinine clearance including cephalosporin and aminoglycoside, antibiotics, flucytosine, cisplatin, cimetidine, trimethoprim, cibenzoline and nitrofurantoin within 14 days or 5 half-lives, whichever is greater, before planned dosing of the investigational medicinal product (IMP).
研究组 & 干预措施
NNC0519-0130
Experimental
Participants will receive single subcutaneous (s.c.) dose of NNC0519-0130.
干预措施: NNC0519-0130 (Drug)
结局指标
主要结局
Area under the curve (AUC)0-∞,NNC0519-0130,SD: Area under the NNC0519-0130 plasma concentration-time curve after a single dose in participants with normal function, and mild, moderate and severe impairment
时间窗: From baseline (visit 2, day 1) until completion of the end-of-study visit (visit 9, day 22)
Measured in hours\* nanomoles per litre (h\*nmol/L).
次要结局
- Maximum concentration (Cmax),NNC0519-0130,SD: Maximum observed NNC0519-0130 plasma concentration after a single dose in participants with normal function, and mild, moderate and severe impairment(From baseline (visit 2, day 1) until completion of the end-of-study visit (visit 9, day 22))
- AUC0-∞,NNC0519-0130,SD: Area under the NNC0519-0130 plasma concentration-time curve after a single dose in participants with kidney failure(From baseline (visit 2, day 1) until completion of the end-of-study visit (visit 9, day 22))
- Cmax,NNC0519-0130,SD: Maximum observed NNC0519-0130 plasma concentration after a single dose in participants with kidney failure(From baseline (visit 2, day 1) until completion of the end-of-study visit (visit 9, day 22))
- Number of adverse events(From time of dosing (visit 2, day 1) until end of study (visit 9, day 22))
研究者
研究点 (1)
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