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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
54
NNC0537-1482 will be administered subcutaneously.
A placebo was used for dilution of the investigational medicinal product.
Charité - Campus Charité Mitte - Charité Research Organisation GmbH
Berlin, Germany
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).
Time frame: From pre-dose (Day 1) until Day 36
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 frame: From pre-dose (Day 1) until Day 36
Time to maximum observed NNC0537-1482 plasma concentration (tmax) in participant with normal function and mild, moderate and severe impairment
Measured as hours.
Time frame: From pre-dose (Day 1) until Day 36
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.
Time frame: From pre-dose (Day 1) until Day 36
Maximum observed NNC0537-1482 plasma concentration (Cmax) in participant with end-stage renal disease (ESRD)
Measured as nmol/L.
Time frame: From pre-dose (Day 1) until Day 36
Time to maximum observed NNC0537-1482 plasma concentration (tmax) in participant with end-stage renal disease (ESRD)
Measured as hours.
Time frame: From pre-dose (Day 1) until Day 36
Number of treatment emergent adverse events (TEAEs)
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Measured as Events.
Time frame: From time of trial product administration (Day 1) until Day 36