Adult Growth Hormone Deficiency, Growth Hormone Disorder, Healthy
Conditions
Brief summary
This trial was conducted in the United States of America (USA). The aim of this clinical trial was to investigate the pharmacokinetics of somatropin in healthy Japanese and Caucasian subjects, and to identify somatostatin-related adverse events.
Interventions
DRUGsomatropin
DRUGplacebo
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
20 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Signed informed consent before any trial related activities * Japanese and Caucasian males respectively * Healthy subjects based upon medical history, physical examination, vital signs, ECG, serum biochemistry and haematology and urinalysis * Body Mass Index (BMI) between 17 and 30 m2/kg, inclusive
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the hGH concentration-time curve (GH AUC0-24h) | from 0 to 24 hours following injection |
| Maximum hGH concentration (GH Cmax) | from 0 to 24 hours following injection |
| Treatment Emergent Adverse Events | from 0 to 24 hours following injection |
Secondary
| Measure | Time frame |
|---|---|
| Growth Factors (IGF-I and IGFBP-3) | — |
| Time to maximum hGH concentration (GH tmax) | — |
| Non-treatment Emergent Adverse Events | — |
| Area under the hGH concentration-time curve GH AUC0-∞) | — |
| Elimination half-life (GH t½) | — |
Countries
United States
Outcome results
None listed