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).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
42
Participants will administer a single dose of NNC0487-0111 subcutaneously using NovoPen®4 by injection into a skinfold on the abdomen.
Charité Research Organisation GmbH
Berlin, Germany
AUC0111,0-∞,SD: Area under the NNC0487-0111 plasma concentration-time curve from time 0 to infinity after a single dose
Measured as hours\*nanomole per liter (h\*nmol/L).
Time frame: From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 28)
Cmax,0111,SD: Maximum observed plasma NNC0487-0111concentration after a single dose
Measured as nanomole per liter (nmol/L).
Time frame: From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 28)
tmax,0111,SD: Time to maximum observed plasma NNC0487-0111 concentration after a single dose
Measured as hours.
Time frame: From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 28)
t½,0111,SD: Terminal half-life of NNC0487-0111 after a single dose
Measured as hours.
Time frame: From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 28)
Vz/F0111,SD: Apparent volume of distribution of NNC0487-0111 after a single dose
Measured as liter (L)
Time frame: From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 28)
CL/F0111,SD: Apparent clearance of NNC0487-0111 after a single dose
Measured as liter per hour (L/h).
Time frame: From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 28)
Number of treatment emergent adverse events (TEAEs)
Measured as number of events.
Time frame: From time of trial product administration (Visit 2, Day 1) until completion of the end of study visit (Visit 9, Day 28)
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