A Research Study Looking Into How a Single Dose of the Medicine NNC0537-1482 Moves Through the Body of Participants With Normal or Reduced Kidney Function
2026年9月2日 更新者:Novo Nordisk A/S
Investigation of Pharmacokinetics of a Single Subcutaneous Dose of NNC0537-1482 in Participants With Various Degrees of Renal Function
The purpose of the study to find out how the study medicine NNC0537-1482 moves through the body in people living with reduced kidney function compared to people with normal kidney function.
All participants will get a single dose of the new medicine.
The data for how much medicine is in the blood over time and compare levels between people with reduced and normal kidney function.
研究概览
研究类型
介入性
注册 (估计的)
54
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习联系方式
- 姓名:Novo Nordisk
- 电话号码:(+1) 866-867-7178
- 邮箱:clinicaltrials@novonordisk.com
学习地点
-
-
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Berlin、德国、10117
- Charité - Campus Charité Mitte - Charité Research Organisation GmbH
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Body Mass Index (BMI) between 18.5 and 39.9 Kilogram per meter square (kg/m^2) (both inclusive) at screening.
- Meeting the pre-defined estimated glomerular filtration rate (eGFR) values based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation (2021) adjusted for the estimated individual body surface area for any of the below renal function groups at screening (Note: The participant must be/have been in their usual health condition at the time of sample collection used for inclusion, as evaluated by the investigator. This will indicate that the participant does not have an acute kidney dysfunction):
Normal renal function: greater than or equal to (≥) 90, Mild renal impairment: 60-89, Moderate renal impairment: 30-59, Severe renal impairment: 15-29 not requiring dialysis, ESRD: less than (<)15 and requiring dialysis treatment.
- All participants in the renal impairment groups should have had chronic kidney disease for at least 3 months prior to screening.
- For participants with ESRD requiring dialysis treatment:
Current treatment with haemodialysis for at least 3 months prior to screening.
Exclusion Criteria:
- Any condition 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, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions (except conditions associated with renal impairment or ESRD).
- Use of medicinal products 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 with the investigational medicinal product (IMP).
- Ongoing treatment with nitrates or nitric oxide (NO) donors (for any route; including isosorbide dinitrate, isosorbide 5 mononitrate, pentaerythritol tetranitrate, nicorandil, nitroglycerin , molsidomine), neprilysin inhibitors (including angiotensin receptor/neprilysin inhibitors), phosphodiesterase (PDE) inhibitors (including PDE3, PDE4, PDE5 inhibitors), or soluble guanylate cyclase (sGC) stimulators.
- Note for participants on dialysis: short-term use of nitroglycerin spray for acute hypertensive episodes or emergencies may be permitted at the investigator's discretion if nitroglycerin is administered as single, short acting dose to treat an acute event (i.e., not scheduled, not for chronic/continuous use); dose, time of administration and reason should be documented in the source documents.
- Specific exclusion criterion for participants with normal renal function:
- Blood pressure at screening outside the range of 100-145 millimetres of mercury (mmHg) for systolic or outside the range of 50-99 mmHg for diastolic.
- Specific exclusion criterion for participants with renal impairment or ESRD:
- Blood pressure at screening outside the range of 100-160 mmHg for systolic and/or ≥100 mmHg for diastolic.
- Unstable renal function within the last 3 months before screening as judged by the investigator, or acute exacerbation of renal disease within 14 days before screening.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:NNC0537-1482
Participants will be administered NNC0537-1482 single dose subcutaneously.
|
NNC0537-1482 将皮下注射。
A placebo was used for dilution of the investigational medicinal product.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Area under the NNC0537-1482 plasma concentration-time curve from 0 hours to the time of the last quantifiable concentration (AUC0-tz) in participant with normal function and mild, moderate and severe impairment
大体时间:From pre-dose (Day 1) until Day 36
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Measured as hour per nanomoles per liter (h*nmol/L).
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From pre-dose (Day 1) until Day 36
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Maximum observed NNC0537-1482 plasma concentration (Cmax) in participant with normal function and mild, moderate and severe impairment
大体时间:From pre-dose (Day 1) until Day 36
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Measured as nanomoles per liter (nmol/L).
|
From pre-dose (Day 1) until Day 36
|
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Time to maximum observed NNC0537-1482 plasma concentration (tmax) in participant with normal function and mild, moderate and severe impairment
大体时间:From pre-dose (Day 1) until Day 36
|
Measured as hours.
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From pre-dose (Day 1) until Day 36
|
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Area under the NNC0537-1482 plasma concentration-time curve from 0 hours to the time of the last quantifiable concentration (AUC0-tz) in participant with end-stage renal disease (ESRD)
大体时间:From pre-dose (Day 1) until Day 36
|
Measured as h*nmol/L.
|
From pre-dose (Day 1) until Day 36
|
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Maximum observed NNC0537-1482 plasma concentration (Cmax) in participant with end-stage renal disease (ESRD)
大体时间:From pre-dose (Day 1) until Day 36
|
Measured as nmol/L.
|
From pre-dose (Day 1) until Day 36
|
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Time to maximum observed NNC0537-1482 plasma concentration (tmax) in participant with end-stage renal disease (ESRD)
大体时间:From pre-dose (Day 1) until Day 36
|
Measured as hours.
|
From pre-dose (Day 1) until Day 36
|
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Number of treatment emergent adverse events (TEAEs)
大体时间:From time of trial product administration (Day 1) until Day 36
|
Measured as Events.
|
From time of trial product administration (Day 1) until Day 36
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任:Clinical Transparency dept. 2834、Organizational Affiliation Enter 'Novo Nordisk A/S
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年9月4日
初级完成 (估计的)
2027年7月6日
研究完成 (估计的)
2027年7月6日
研究注册日期
首次提交
2026年9月2日
首先提交符合 QC 标准的
2026年9月2日
首次发布 (实际的)
2026年9月9日
研究记录更新
最后更新发布 (实际的)
2026年9月9日
上次提交的符合 QC 标准的更新
2026年9月2日
最后验证
2026年9月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- NN6537-8759
- U1111-1335-3619 (其他标识符:World Health Organization (WHO))
- 2026-525271-57 (其他标识符:EU CT number)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
是的
IPD 计划说明
According to the Novo Nordisk disclosure commitment on novonordisktrials.com
药物和器械信息、研究文件
研究美国 FDA 监管的药品
是的
研究美国 FDA 监管的设备产品
不
在美国制造并从美国出口的产品
是的
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