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NCT Number: NCT03810664

A 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.

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Key information

Conditions

Healthy Male Volunteers

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

QPS Miami Research Associates

Miami, Florida, 33143, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

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).

Primary outcomes

  1. Area under the curve (AUC) of the serum concentration-time from time 0 to a specific time (AUCt)

    Time frame: 30 days

  2. Area under the curve (AUC) of the serum concentration-time from time 0 to infinity (AUC∞)

    Time frame: 30 days

  3. Serum concentration from of maximum concentration (Cmax) of somatrogon levels in serum

    Time frame: 30 days

Secondary outcomes

  1. AUCt of IGF-1 and IGFBP-3 levels

    Time frame: 30 days

  2. AUC∞ of IGF-1 and IGFBP-3 levels

    Time frame: 30 days

  3. Cmax of IGF-1 and IGFBP-3 levels

    Time frame: 30 days

  4. Time to maximum concentration (Tmax)

    Time frame: 30 days

  5. Apparent Terminal Rate Constant (λz) and t½

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

OPKO Health, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 22, 2019
Registry last updated
Apr 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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