Adult Growth Hormone Deficiency, Growth Hormone Deficiency in Children, Growth Hormone Disorder
Conditions
Brief summary
This trial is conducted in Europe. The aim of this trial is to investigate the effect of abnormal liver (hepatic) function on the amount of trial drug getting into the body and removal of the drug from the body (this is called pharmacokinetics). In this trial the participants will receive three subcutaneous (under the skin) injections of the trial drug somapacitan. Somapacitan is a long-acting growth hormone analogue (a drug similar to human growth hormone) intended for once-weekly subcutaneous administration.
Interventions
DRUGSomapacitan
3 once-weekly subcutaneous administrations (s.c., under the skin) of somapacitan with a dose of 0.08 mg/kg
Sponsors
Novo Nordisk A/S
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Sponsor staff involved in the clinical trial is masked according to company standard procedures
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female aged 18-75 years (both inclusive) * Body mass index of 18.5-39.9 kg/sqm (both inclusive) * Subjects with normal hepatic function or hepatic impairment (mild or moderate)
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) for at least 16 days after the last trial product administration * 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 blood draw in excess of 25 mL in the past 30 days, or donation of blood or plasma in excess of 400 mL within the 90 days preceding screening * Any disorder, except for conditions associated with hepatic impairment in the group of subjects with compromised hepatic function, which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol
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 somapacitan measured in blood |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to maximum serum concentration of somapacitan | After the last dosing on Day 15 until Day 43 | Calculated based on plasma somapacitan activity measured in blood |
| Incidence of adverse events | From first dosing to Day 43 | Count |
| Occurrence of anti-somapacitan antibodies | From Day 0 to Day 43 | Count |
| Maximum serum concentration of somapacitan | After the last dosing on Day 15 until Day 43 | Calculated based on plasma somapacitan activity measured in blood |
Countries
Slovakia
Outcome results
None listed