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

NCT03810664 | Completed Phase 1 FDA Drug

• 1 other identifier: CP-4-011
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Male Volunteers

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• 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

Study Arms (2)

Somatrogon pre-filled PEN

EXPERIMENTAL

Drug: Somatrogon

Somatrogon frozen liquid formulation

ACTIVE COMPARATOR

Drug: Somatrogon

Interventions

Somatrogon DRUG

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).

Somatrogon frozen liquid formulation; Somatrogon pre-filled PEN

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: Healthy male volunteers
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

Sponsors & Collaborators

• OPKO Health, Inc.: lead

Study Sites (1)

QPS Miami Research Associates

Miami, Florida, 33143, United States

Location

MeSH Terms

Interventions

somatrogon

Study Officials

• Sandra Pagnusset, MD

  QPS Miami Research Associates

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: January 8, 2019
• First Posted: January 22, 2019
• Study Start: January 18, 2019
• Primary Completion: April 19, 2019
• Study Completion: April 19, 2019
• Last Updated: April 28, 2020

Record last verified: 2020-04

Locations

US (1)