Adult Growth Hormone Deficiency, Growth Hormone Deficiency in Children, Growth Hormone Disorder
Conditions
Brief summary
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
Interventions
DRUGSomapacitan
All subjects will receive three (0.08 mg/kg) consecutive once-weekly s.c. (under the skin) administrations of somapacitan
Sponsors
Novo Nordisk A/S
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Male or female, aged 18-75 years (both inclusive) at the time of signing informed consent * Body mass index between 18.5-34.9 kg/sqm (both inclusive) * Meeting the pre-defined glomerular filtration rate for any of the renal function groups 1-4 (based on the measured glomerular filtration rate using exogenous sinistrin (Inutest®) as a filtration marker) or being in treatment with haemodialysis
Exclusion criteria
* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measure as required by local regulation or practice). Male of reproductive age who or whose partner(s) is not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice) or male who is not willing to refrain from donating semen for at least 16 days after last trial product administration * Any disorder, except for conditions associated with renal impairment in the groups of subjects with reduced renal function, which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol. For example, arterial hypertension, anaemia, impaired glucose tolerance or type 2 diabetes are accepted in the group of subjects with renal impairment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area under the somapacitan serum concentration time curve | From time 0 to 168 hours after the last dosing on Day 15. | Calculated based on the serum concentrations measured in ug/l |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum serum concentration of somapacitan | After the last dosing on Day 15 up until Day 43 | Measured in ng/ml |
| Time to maximum serum concentration of somapacitan | After the last dosing on Day 15 up until Day 43 | Calculated based on the serum concentrations measured in ug/l |
| Incidence of adverse events | Day 0 - 43 | Count and % of events |
| Occurrence of anti-somapacitan antibodies | Day 0 - 43 | Count or % of events |
Countries
Germany
Outcome results
None listed