Chronic Kidney Disease
Conditions
Brief summary
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.
Interventions
DRUGNNC0537-1482
NNC0537-1482 will be administered subcutaneously.
OTHERPlacebo (for dilution only)
A placebo was used for dilution of the investigational medicinal product.
Sponsors
Novo Nordisk A/S
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | From pre-dose (Day 1) until Day 36 | Measured as hour per nanomoles per liter (h\*nmol/L). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum observed NNC0537-1482 plasma concentration (Cmax) in participant with normal function and mild, moderate and severe impairment | From pre-dose (Day 1) until Day 36 | Measured as nanomoles per liter (nmol/L). |
| Time to maximum observed NNC0537-1482 plasma concentration (tmax) in participant with normal function and mild, moderate and severe impairment | From pre-dose (Day 1) until Day 36 | Measured as hours. |
| 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) | From pre-dose (Day 1) until Day 36 | Measured as h\*nmol/L. |
| Maximum observed NNC0537-1482 plasma concentration (Cmax) in participant with end-stage renal disease (ESRD) | From pre-dose (Day 1) until Day 36 | Measured as nmol/L. |
| Time to maximum observed NNC0537-1482 plasma concentration (tmax) in participant with end-stage renal disease (ESRD) | From pre-dose (Day 1) until Day 36 | Measured as hours. |
| Number of treatment emergent adverse events (TEAEs) | From time of trial product administration (Day 1) until Day 36 | Measured as Events. |
Countries
Germany
Contacts
CONTACTNovo Nordisk
STUDY_DIRECTORClinical Transparency dept. 2834
Organizational Affiliation Enter 'Novo Nordisk A/S
Outcome results
None listed