Charité - Campus Charité Mitte - Charité Research Organisation GmbH
Berlin, 10117, Germany
NCT Number: NCT07808788
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.
Trial opening soon.
Get Notified18 year–75 year
All sexes
Interventional
Phase 1
Berlin, 10117, Germany
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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.
Current treatment with haemodialysis for at least 3 months prior to screening.
Exclusion criteria
NNC0537-1482 will be administered subcutaneously.
A placebo was used for dilution of the investigational medicinal product.
Time frame: From pre-dose (Day 1) until Day 36
Measured as hour per nanomoles per liter (h*nmol/L).
Time frame: From pre-dose (Day 1) until Day 36
Measured as nanomoles per liter (nmol/L).
Time frame: From pre-dose (Day 1) until Day 36
Measured as hours.
Time frame: From pre-dose (Day 1) until Day 36
Measured as h*nmol/L.
Time frame: From pre-dose (Day 1) until Day 36
Measured as nmol/L.
Time frame: From pre-dose (Day 1) until Day 36
Measured as hours.
Time frame: From time of trial product administration (Day 1) until Day 36
Measured as Events.
Contact information is provided by the study sponsor or research team.
Novo Nordisk A/S
Industry
Investigation of Pharmacokinetics of a Single Subcutaneous Dose of NNC0537-1482 in Participants With Various Degrees of Renal Function
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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