Investigation of Pharmacokinetics, Safety and Tolerability of a Single Subcutaneous Dose of NNC0487-0111 in Participants With Various Degrees of Renal Impairment and Normal Renal Function
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- AUC0111,0-∞,SD: Area under the NNC0487-0111 plasma concentration-time curve from time 0 to infinity after a single dose
研究概览
简要总结
Novo Nordisk is developing the study medicine NNC0487-0111 to treat people living with type 2 diabetes and/or people living with overweight or obesity. The aim of this study is to see if blood levels of NNC0487-0111 are the same in people living with various degrees of reduced kidney function as for people with normal kidney function. Participants will be given one single injection by the study staff in a skinfold in their stomach using a pen device (NovoPen®4).
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
- 否
入选标准
- •Male or female, aged 18-80 years (both inclusive) at the time of signing the informed consent
- •Body mass index (BMI) between 20.0 and 39.9 kilogram per square meter (kg/m^2) (both inclusive) at screening.
- •Meeting the pre-defined eGFR values based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation (2021) adjusted for the estimated individual body surface area (BSA);
- •Normal renal function - greater than or equal to 90 mL/min
- •Mild renal impairment - 60 - 89 (mL/min)
- •Moderate renal impairment - 30 - 59 (mL/min)
- •Severe renal impairment - less than 30 (mL/min) not requiring dialysis
- •End-stage renal disease (ESRD) - Requiring dialysis treatment
- •For ESRD: Participants requiring dialysis treatment should be on current treatment with haemodialysis.
排除标准
- •Any disorder, unwillingness, or inability which in the investigator's opinion might jeopardize participant's safety or compliance with the protocol.
- •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 dosing the investigational medicinal product (IMP).
- •Presence or history of any clinically relevant respiratory, metabolic, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions(except conditions associated with renal impairment or ESRD).
研究组 & 干预措施
Mild Renal Impairment
Participants with mild renal impairment (estimated glomerular filtration rate [eGFR] - 60 - 89 milliliter per min [mL/min]) will administer a single dose of NNC0487-0111 on Day 1.
干预措施: NNC0487-0111 (Drug)
Moderate Renal Impairment
Participants with moderate renal impairment (eGFR - 30 - 59 mL/min) will administer a single dose of NNC0487-0111 on Day 1.
干预措施: NNC0487-0111 (Drug)
Severe Renal Impairment
Participants with severe renal impairment (eGFR - less than 30 mL/min not requiring dialysis) will administer a single dose of NNC0487-0111 on Day 1.
干预措施: NNC0487-0111 (Drug)
End-Stage Renal Disease (ESRD)
Participants with ESRD (requiring dialysis treatment) will administer a single dose of NNC0487-0111 on Day 1.
干预措施: NNC0487-0111 (Drug)
Normal Renal Function
Participants with normal renal function (eGFR - greater than or equals 90) will administer a single dose of NNC0487-0111 on Day 1.
干预措施: NNC0487-0111 (Drug)
结局指标
主要结局
AUC0111,0-∞,SD: Area under the NNC0487-0111 plasma concentration-time curve from time 0 to infinity after a single dose
时间窗: From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 28)
Measured as hours\*nanomole per liter (h\*nmol/L).
次要结局
- Cmax,0111,SD: Maximum observed plasma NNC0487-0111concentration after a single dose(From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 28))
- tmax,0111,SD: Time to maximum observed plasma NNC0487-0111 concentration after a single dose(From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 28))
- t½,0111,SD: Terminal half-life of NNC0487-0111 after a single dose(From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 28))
- Vz/F0111,SD: Apparent volume of distribution of NNC0487-0111 after a single dose(From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 28))
- CL/F0111,SD: Apparent clearance of NNC0487-0111 after a single dose(From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 28))
- Number of treatment emergent adverse events (TEAEs)(From time of trial product administration (Visit 2, Day 1) until completion of the end of study visit (Visit 9, Day 28))