A Clinical Study Investigating the Comparability of Somatrogon in Two Different Drug Product Presentations

Phase 1

Completed

• Conditions: Healthy Male Volunteers
• Interventions: Drug: Somatrogon

• Registration Number: NCT03810664
• Lead Sponsor: OPKO Health, Inc.

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.

Study Timeline

• Study First Submitted: 2019-01-08
• Study First Submitted QC: 2019-01-17
• Study Start: 2019-01-18
• Study First Posted: 2019-01-22
• Primary Completion: 2019-04-19
• Study Completion: 2019-04-19
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-27
• Last Update Posted: 2020-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 49

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Somatrogon pre-filled PEN	Somatrogon	-
Somatrogon frozen liquid formulation	Somatrogon	-

Primary Outcome Measures

Name	Time	Method
Area under the curve (AUC) of the serum concentration-time from time 0 to a specific time (AUCt)	30 days
Serum concentration from of maximum concentration (Cmax) of somatrogon levels in serum	30 days
Area under the curve (AUC) of the serum concentration-time from time 0 to infinity (AUC∞)	30 days

Secondary Outcome Measures

Name	Time	Method
AUCt of IGF-1 and IGFBP-3 levels	30 days
AUC∞ of IGF-1 and IGFBP-3 levels	30 days
Time to maximum concentration (Tmax)	30 days
Apparent Terminal Rate Constant (λz) and t½	30 days
Cmax of IGF-1 and IGFBP-3 levels	30 days

Trial Locations

Locations (1)

QPS Miami Research Associates; 🇺🇸 Miami, Florida, United States