This study will compare two strengths of the new long-acting growth hormone somapacitan. The aim of this study is to test if both strengths are taken up in the blood in the same way. During three separate dosing visits participants will get a total of 3 injections of the study medicine. Somapacitan is not yet approved and therefore cannot be prescribed by a doctor outside of this study. The study duration is between 10 and 15 weeks. Participants will have 17 visits with the study doctor. Three visits will each comprise 6 in-house days with overnight stays. In total, at least 15 overnight stays at the clinic. There will be blood samplings during the study. Participants must come to the clinic regularly for these blood samplings. People who have already received growth hormones in the past or who are growth hormone deficient cannot be in the study. People cannot be in the study if the study doctor thinks that there are risks for their health. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
33
5 mg/1.5 ml and 10 mg/1.5 ml doses administered s.c. (subcutaneously, under the skin)
Novo Nordisk Investigational Site
Neuss, Germany
Area under the somapacitan serum concentration time curve from time 0 to the time of the last quantifiable concentration after dosing
ng\*h/mL
Time frame: 0 to 504 hours after trial product administration
Maximum serum concentration of somapacitan
ng/mL
Time frame: 0 to 504 hours after trial product administration
Area under the somapacitan serum concentration time curve from time 0 to 168 hours after dosing
ng\*h/mL
Time frame: 0 to 168 hours after trial product administration
Area under the somapacitan serum concentration time curve from time 0 to infinity
ng\*h/mL
Time frame: 0 to 504 hours after trial product administration
Time to maximum serum concentration of somapacitan
Hours
Time frame: 0 to 504 hours after trial product administration
Terminal half-life of somapacitan
Hours
Time frame: 0 to 504 hours after trial product administration
Area under the insulin-like growth factor I (IGF-I) serum concentration time curve from time 0 to 168 hours after dosing
ng\*h/mL
Time frame: 0 to 168 hours after trial product administration
Maximum serum concentration of IGF-I after dosing
ng/mL
Time frame: 0 to 504 hours after trial product administration
Time to maximum serum concentration of IGF-I after dosing
Hours
Time frame: 0 to 504 hours after trial product administration
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