A Research Study Looking Into Blood Levels of the Medicine NNC0487-0111 in the Body and How Well it is Tolerated in Participants With Reduced Kidney Function and Normal Kidney Function
- Registration Number
- NCT06559527
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
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Male or female, aged 18-80 years (both inclusive) at the time of signing the informed consent
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Body mass index (BMI) between 20.0 and 39.9 kilogram per square meter (kg/m^2) (both inclusive) at screening.
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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
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For ESRD: Participants requiring dialysis treatment should be on current treatment with haemodialysis.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description End-Stage Renal Disease (ESRD) NNC0487-0111 Participants with ESRD (requiring dialysis treatment) will administer a single dose of NNC0487-0111 on Day 1. Normal Renal Function NNC0487-0111 Participants with normal renal function (eGFR - greater than or equals 90) will administer a single dose of NNC0487-0111 on Day 1. Mild Renal Impairment NNC0487-0111 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. Moderate Renal Impairment NNC0487-0111 Participants with moderate renal impairment (eGFR - 30 - 59 mL/min) will administer a single dose of NNC0487-0111 on Day 1. Severe Renal Impairment NNC0487-0111 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.
- Primary Outcome Measures
Name Time Method AUC0111,0-∞,SD: Area under the NNC0487-0111 plasma concentration-time curve from time 0 to infinity after a single dose 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).
- Secondary Outcome Measures
Name Time Method 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) Measured as nanomole per liter (nmol/L).
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) Measured as hours.
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) Measured as hours.
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) Measured as liter (L)
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) Measured as liter per hour (L/h).
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) Measured as number of events.
Trial Locations
- Locations (1)
Charité Research Organisation GmbH
🇩🇪Berlin, Germany