Healthy Male Volunteers
Conditions
Brief summary
This is a Phase 1, single-center, open-label randomized, 2×2 crossover (Ref Test \| Test Ref) study with a washout of two weeks to establish bioequivalence between single dose of somatrogon in a PEN to somatrogon in VIAL administered sc in healthy male volunteers.
Detailed description
The subjects will undergo a screening period (Day -28 to -1), and when eligible for study participation will be randomized to receive one sc injection of one of two somatrogon drug product presentations on Day 0, either the PEN or VIAL presentation. A series of blood draws and study procedures will be carried out over the course of the next 10 days to evaluate the subjects. Following a two week washout period, the subjects will be brought back to the clinic to receive the other somatrogon drug product presentation, and once again followed for the next 14 days to study completion.
Interventions
DRUGSomatrogon
A single dose of 12 mg of somatrogon will be injected as one sc injection to the arm on each dosing day (Day 0 and Day 14).
Sponsors
OPKO Health, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Intervention model description
This is a Phase 1, single-center, open-label randomized, 2×2 crossover (Ref Test \| Test Ref) study with a washout of two weeks to establish bioequivalence between single dose of somatrogon in a PEN to somatrogon in VIAL administered sc in healthy male volunteers.
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male volunteers aged 18-55 (inclusive) years * Body Mass Index (BMI) 19 to 32 kg/m2 (inclusive) and weighing at least 55 kg * Non-smoking (by declaration) for a period of at least six months prior to screening visit
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the curve (AUC) of the serum concentration-time from time 0 to a specific time (AUCt) | 30 days |
| Area under the curve (AUC) of the serum concentration-time from time 0 to infinity (AUC∞) | 30 days |
| Serum concentration from of maximum concentration (Cmax) of somatrogon levels in serum | 30 days |
Secondary
| Measure | Time frame |
|---|---|
| Time to maximum concentration (Tmax) | 30 days |
| AUCt of IGF-1 and IGFBP-3 levels | 30 days |
| Apparent Terminal Rate Constant (λz) and t½ | 30 days |
| AUC∞ of IGF-1 and IGFBP-3 levels | 30 days |
| Cmax of IGF-1 and IGFBP-3 levels | 30 days |
Countries
United States
Outcome results
None listed