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

A Phase 1, Single-Center, Randomized, Cross-Over, Clinical Study Investigating the Comparability of Somatrogon in Two Different Drug Product Presentations

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.

Study Overview

• Status: Completed
• Conditions: Healthy Male Volunteers
• Intervention / Treatment: Drug: Somatrogon

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 Type: Interventional
• Enrollment (Actual): 49
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33143
      • QPS Miami Research Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 53 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Somatrogon pre-filled PEN	Drug: Somatrogon; 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).
Active Comparator: Somatrogon frozen liquid formulation	Drug: Somatrogon; 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).

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Time Frame
AUCt of IGF-1 and IGFBP-3 levels	30 days
AUC∞ of IGF-1 and IGFBP-3 levels	30 days
Cmax 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

Collaborators and Investigators

• Sponsor: OPKO Health, Inc.
• Investigators: Principal Investigator: Sandra Pagnusset, MD, QPS Miami Research Associates

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2019
• Primary Completion (Actual): April 19, 2019
• Study Completion (Actual): April 19, 2019

Study Registration Dates

• First Submitted: January 8, 2019
• First Submitted That Met QC Criteria: January 17, 2019
• First Posted (Actual): January 22, 2019

Study Record Updates

• Last Update Posted (Actual): April 28, 2020
• Last Update Submitted That Met QC Criteria: April 27, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: CP-4-011

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No