The trial is conducted in Europe. The aim of the trial is to investigate the steady state exposure of somapacitan in subjects with various degrees of renal impairment (mild, moderate, severe renal impairment, requiring haemodialysis treatment) compared to subjects with normal renal function
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
44
All subjects will receive three (0.08 mg/kg) consecutive once-weekly s.c. (under the skin) administrations of somapacitan
Novo Nordisk Investigational Site
Berlin, Germany
Area under the somapacitan serum concentration time curve
Calculated based on the serum concentrations measured in ug/l
Time frame: From time 0 to 168 hours after the last dosing on Day 15.
Maximum serum concentration of somapacitan
Measured in ng/ml
Time frame: After the last dosing on Day 15 up until Day 43
Time to maximum serum concentration of somapacitan
Calculated based on the serum concentrations measured in ug/l
Time frame: After the last dosing on Day 15 up until Day 43
Incidence of adverse events
Count and % of events
Time frame: Day 0 - 43
Occurrence of anti-somapacitan antibodies
Count or % of events
Time frame: Day 0 - 43
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