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

Healthy Male Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03810664
• Other study ID #: CP-4-011
• Status: Completed
• Phase: Phase 1
• Start date: January 18, 2019
• Est. completion date: April 19, 2019

Study information

• Verified date: April 2020
• Source: OPKO Health, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: April 19, 2019
• Est. primary completion date: April 19, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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:

-

Related Conditions & MeSH terms

• Healthy Male Volunteers

Intervention

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).

Locations

Country	Name	City	State
United States	QPS Miami Research Associates	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
OPKO Health, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the curve (AUC) of the serum concentration-time from time 0 to a specific time (AUCt)		30 days
Primary	Area under the curve (AUC) of the serum concentration-time from time 0 to infinity (AUC8)		30 days
Primary	Serum concentration from of maximum concentration (Cmax) of somatrogon levels in serum		30 days
Secondary	AUCt of IGF-1 and IGFBP-3 levels		30 days
Secondary	AUC8 of IGF-1 and IGFBP-3 levels		30 days
Secondary	Cmax of IGF-1 and IGFBP-3 levels		30 days
Secondary	Time to maximum concentration (Tmax)		30 days
Secondary	Apparent Terminal Rate Constant (?z) and t½		30 days