An Open-label Trial Investigating the Pharmacokinetics and the Tolerability of NNC0174-0833 in Subjects With Normal Renal Function and Impaired Renal Function
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 plasma NNC0174-0833 concentration-time curve after a single dose
研究概览
简要总结
The study looks at the blood levels of a new study medicine in people with normal and impaired kidney function. Participants will get the study medicine called NNC0174-0833. This is an experimental medicine and has not been approved by the US FDA. It is being developed as a new medicine for weight management. Participants will get 1 injection of the study medicine by a study nurse at the clinic. The injection will be with a needle in a skin fold in the stomach area. The study will last for about 9 weeks. Participants will have about 7 visits with the study staff or the doctor. At the visits, participants will have clinical checks done and blood samples taken. Participants will be collecting their urine several times during the study. Participants will be asked about their health, medical history and habits. People who are already in another research study cannot take part. Only women who are not able to become pregnant can take part in the study. Only men who do not plan to father a child during the study or 6 weeks following the dose administration can take part in the study.
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 80 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 18-80 years (both inclusive) at the time of signing informed consent.
- •Meeting the pre-defined GFR criteria using estimated GFR (eGFR) based on serum creatinine for any of the renal function groups:
- •For subjects with normal renal function: eGFR of equal to or above 90 mL/min
- •For patients with mild renal impairment: eGFR of 60-89 mL/min
- •For patients with moderate renal impairment: eGFR of 30-59 mL/min
- •For patients with severe renal impairment: eGFR of <30 mL/min not requiring dialysis
排除标准
- •Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.
- •Use of prescription or non-prescription drugs, or non-routine vitamins, which at the investigators judgement may affect subject safety or the results of the trial.
研究组 & 干预措施
Normal renal function
All subjects will receive one dose of NNC0174-0833.
干预措施: NNC0174-0833 (Drug)
Mild renal impairment
All subjects will receive one dose of NNC0174-0833.
干预措施: NNC0174-0833 (Drug)
Moderate renal impairment
All subjects will receive one dose of NNC0174-0833.
干预措施: NNC0174-0833 (Drug)
Severe renal impairment
All subjects will receive one dose of NNC0174-0833.
干预措施: NNC0174-0833 (Drug)
结局指标
主要结局
Area under the plasma NNC0174-0833 concentration-time curve after a single dose
时间窗: From baseline (Visit 2, Day 1, pre-dose) until completion of the end of trial visit (Visit 7, Day 36)
nmol\*h/L
次要结局
- Maximum observed plasma NNC0174-0833 concentration after a single dose(From baseline (Visit 2, Day 1, pre-dose) until completion of the end of trial visit (visit 7, Day 36))
- Time to maximum observed plasma NNC0174-0833 concentration after a single dose(From baseline (Visit 2, Day 1, pre-dose) until completion of the end of trial visit (Visit 7, Day 36))
- Number of treatment emergent adverse events (TEAEs)(From time of trial product administration (Visit 2, Day 1) until completion of the end of trial visit (Visit 7, Day 36))