About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Body Mass Index (BMI) between 18.5 and 39.9 Kilogram per meter square (kg/m²) (both inclusive) at screening.
All participants in the renal impairment groups should have had chronic kidney disease for at least 3 months prior to screening.
Disqualifiers
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.
Trial design
Single group
Treatments tested in this trial
NNC0537-1482
DrugNNC0537-1482 will be administered subcutaneously.
Placebo (for dilution only)
Other interventionA placebo was used for dilution of the investigational medicinal product.
Treatment groups
Trial outcomes
Primary outcomes
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
Measured as hour per nanomoles per liter (h\*nmol/L).
Secondary outcomes
Maximum observed NNC0537-1482 plasma concentration (Cmax) in participant with normal function and mild, moderate and severe impairment
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
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)
Measured as h\*nmol/L.
Maximum observed NNC0537-1482 plasma concentration (Cmax) in participant with end-stage renal disease (ESRD)
Measured as nmol/L.
Sponsors and contacts
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