Participants will receive one insulin icodec dose, which will be administered in the morning of the day of dosing. The study will last for about 8 weeks. Participants will have 8 visits with the study doctor in the clinical research unit. Insulin icodec will be injected into a skin fold with a small needle (subcutaneous application) using a pen injector prefilled with a volume of 3 mL (about a spoonful). Participants must not participate if they meet certain conditions called exclusion criteria, such as an age of below 18 years or above 70 years, if participants are over- or underweight, using certain medicines, or have serious health conditions (other than impaired liver function ). Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Insulin icodec will be investigated in participants with impaired liver function and subjects with normal liver function. Administered as a single dose subcutaneously (under the skin) The study will last for about 8 weeks.
Pharmaceutical Research Associates CZ, s.r.o.
Prague, Czechia
Summit Clinical Research s.r.o.
Bratislava, Slovakia
AUC,Ico,0-inf,SD, Area under the serum insulin icodec concentration-time curve after a single dose
From 0 hours until infinity after trial product administration (pmol\*h/L)
Time frame: Day 1
Cmax,Ico,SD, Maximum observed serum insulin icodec concentration after a single dose
From 0 hours until last measurement time after trial product administration (pmol/L)
Time frame: Day 1
tmax,Ico,SD, Time to maximum observed serum insulin icodec concentration after a single dose
From 0 hours until last measurement time after trial product administration (hours)
Time frame: Day 1
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