<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03810664</url>
  </required_header>
  <id_info>
    <org_study_id>CP-4-011</org_study_id>
    <nct_id>NCT03810664</nct_id>
  </id_info>
  <brief_title>A Clinical Study Investigating the Comparability of Somatrogon in Two Different Drug Product Presentations</brief_title>
  <official_title>A Phase 1, Single-Center, Randomized, Cross-Over, Clinical Study Investigating the Comparability of Somatrogon in Two Different Drug Product Presentations</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>OPKO Health, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>OPKO Health, Inc.</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a Phase 1, single-center, open-label randomized, 2×2 crossover (Ref Test | Test Ref)&#xD;
      study with a washout of two weeks to establish bioequivalence between single dose of&#xD;
      somatrogon in a PEN to somatrogon in VIAL administered sc in healthy male volunteers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The subjects will undergo a screening period (Day -28 to -1), and when eligible for study&#xD;
      participation will be randomized to receive one sc injection of one of two somatrogon drug&#xD;
      product presentations on Day 0, either the PEN or VIAL presentation. A series of blood draws&#xD;
      and study procedures will be carried out over the course of the next 10 days to evaluate the&#xD;
      subjects. Following a two week washout period, the subjects will be brought back to the&#xD;
      clinic to receive the other somatrogon drug product presentation, and once again followed for&#xD;
      the next 14 days to study completion.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 18, 2019</start_date>
  <completion_date type="Actual">April 19, 2019</completion_date>
  <primary_completion_date type="Actual">April 19, 2019</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <intervention_model_description>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.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area under the curve (AUC) of the serum concentration-time from time 0 to a specific time (AUCt)</measure>
    <time_frame>30 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the curve (AUC) of the serum concentration-time from time 0 to infinity (AUC∞)</measure>
    <time_frame>30 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Serum concentration from of maximum concentration (Cmax) of somatrogon levels in serum</measure>
    <time_frame>30 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>AUCt of IGF-1 and IGFBP-3 levels</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC∞ of IGF-1 and IGFBP-3 levels</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax of IGF-1 and IGFBP-3 levels</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to maximum concentration (Tmax)</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent Terminal Rate Constant (λz) and t½</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">49</enrollment>
  <condition>Healthy Male Volunteers</condition>
  <arm_group>
    <arm_group_label>Somatrogon pre-filled PEN</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Somatrogon frozen liquid formulation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Somatrogon</intervention_name>
    <description>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).</description>
    <arm_group_label>Somatrogon frozen liquid formulation</arm_group_label>
    <arm_group_label>Somatrogon pre-filled PEN</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male volunteers aged 18-55 (inclusive) years&#xD;
&#xD;
          -  Body Mass Index (BMI) 19 to 32 kg/m2 (inclusive) and weighing at least 55 kg&#xD;
&#xD;
          -  Non-smoking (by declaration) for a period of at least six months prior to screening&#xD;
             visit&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Healthy male volunteers</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sandra Pagnusset, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>QPS Miami Research Associates</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>QPS Miami Research Associates</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>January 8, 2019</study_first_submitted>
  <study_first_submitted_qc>January 17, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 22, 2019</study_first_posted>
  <last_update_submitted>April 27, 2020</last_update_submitted>
  <last_update_submitted_qc>April 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03810664
org study id: CP-4-011
nct id: NCT03810664
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
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.
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.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: 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.
primary purpose: Other
masking: None (Open Label)
measure: Area under the curve (AUC) of the serum concentration-time from time 0 to a specific time (AUCt)
time frame: 30 days
measure: Area under the curve (AUC) of the serum concentration-time from time 0 to infinity (AUC∞)
time frame: 30 days
measure: Serum concentration from of maximum concentration (Cmax) of somatrogon levels in serum
time frame: 30 days
measure: AUCt of IGF-1 and IGFBP-3 levels
time frame: 30 days
measure: AUC∞ of IGF-1 and IGFBP-3 levels
time frame: 30 days
measure: Cmax of IGF-1 and IGFBP-3 levels
time frame: 30 days
measure: Time to maximum concentration (Tmax)
time frame: 30 days
measure: Apparent Terminal Rate Constant (λz) and t½
time frame: 30 days
arm group label: Somatrogon pre-filled PEN
arm group type: Experimental
arm group label: Somatrogon frozen liquid formulation
arm group type: Active Comparator
intervention type: Drug
intervention name: Somatrogon
description: 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).
arm group label: Somatrogon frozen liquid formulation
arm group label: Somatrogon pre-filled PEN
criteria: 
gender: Male
gender based: Yes
gender description: Healthy male volunteers
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sandra Pagnusset, MD
role: Principal Investigator
affiliation: QPS Miami Research Associates
facility: 
country: United States
responsible party type: Sponsor