<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/NCT02233751</url>
  </required_header>
  <id_info>
    <org_study_id>QST-14-004</org_study_id>
    <nct_id>NCT02233751</nct_id>
  </id_info>
  <brief_title>Pharmacokinetic Study of Subcutaneous Testosterone Enanthate</brief_title>
  <official_title>An Open-Label Study to Evaluate the Pharmacokinetics of Testosterone Enanthate After Single-Dose Injection Via QuickShot® Testosterone in Healthy Male Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Antares Pharma Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Antares Pharma Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Evaluation of pharmacokinetics of subcutaneous testosterone enanthate&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Evaluation of pharmacokinetics and safety profile of testosterone enanthate injected&#xD;
      subcutaneously via auto-injector in healthy male volunteers&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">October 2014</completion_date>
  <primary_completion_date type="Actual">October 2014</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>The dose assignment was random among the enrolled participants.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Maximum Concentration (Cmax) for Serum Testosterone and Testosterone Enanthate</measure>
    <time_frame>Maximum serum concentrations occurring during an 8 days study window</time_frame>
    <description>Cmax = Maximum blood concentration (ng/dL) of TT=Total Testosterone and TE=Testosterone Enanthate</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Concentration-time Curve From Time Zero to Time t</measure>
    <time_frame>168 hrs</time_frame>
    <description>AUC(0-168h) (ng⋅hr/dL) = area under the concentration-time curve from time zero to Day 8 (1 week);</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Concentration-time Curve From Time Zero to Infinity</measure>
    <time_frame>time zero to infinity</time_frame>
    <description>AUC(0-inf) (ng⋅hr/dL) = area under the concentration-time curve from time zero to infinity</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to Maximum Concentration (Tmax)(hr)</measure>
    <time_frame>The sample time of Cmax during a 168 hour sampling interval</time_frame>
    <description>tmax = Time to reach maximum concentration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Half-life (t 1/2)(hr)</measure>
    <time_frame>168 hours</time_frame>
    <description>t 1/2 = Half-life is the time required for a concentration to reduce to half its initial value</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clearance CL/F (L/hr)</measure>
    <time_frame>168 hours</time_frame>
    <description>Clearance - volume of plasma from which TT/TE is completely removed per unit time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vd/F (L)</measure>
    <time_frame>168 hours</time_frame>
    <description>Vd/F (L) = Apparent volume of distribution</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Hypogonadism</condition>
  <arm_group>
    <arm_group_label>Testosterone enanthate auto-injector - 50 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Testosterone enanthate auto-injector - 50 mg (SC injection)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Testosterone enanthate auto-injector - 200 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Testosterone enanthate auto-injector- 200 mg (SC injection)</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Testosterone enanthate auto-injector</intervention_name>
    <description>Randomization then administration of combination product study medication according to group assignment</description>
    <arm_group_label>Testosterone enanthate auto-injector - 200 mg</arm_group_label>
    <arm_group_label>Testosterone enanthate auto-injector - 50 mg</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy adult male subjects, 18-55 years of age, inclusive, at the time of signing the&#xD;
             informed consent;&#xD;
&#xD;
          -  Body weight ≥50 kg and body mass index within the range 19-30 kg/m2, inclusive, at&#xD;
             screening;&#xD;
&#xD;
          -  Medically healthy subjects with clinically insignificant screening and check-in&#xD;
             results (medical history, 12-lead electrocardiogram [ECG], physical examination, and&#xD;
             laboratory tests); and&#xD;
&#xD;
          -  Subjects who are able to understand and are willing and able to give their signed&#xD;
             informed consent before any trial-related procedures are performed.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Currently diagnosed or a history of asthma, urticarial, angioedema, anaphylaxis,&#xD;
             atopic dermatitis, clinically significant abnormality of skin of the abdomen, cancer,&#xD;
             diabetes, or any other clinically significant cardiovascular, respiratory, metabolic,&#xD;
             renal, hepatic, gastrointestinal, hematological, dermatological, venereal,&#xD;
             neurological, psychiatric, or other major disorders;&#xD;
&#xD;
          -  History of benign prostate hypertrophy (BPH), prostate cancer, or abnormal prostate&#xD;
             specific antigen (PSA) values;&#xD;
&#xD;
          -  PSA level &gt; 3 ng/ml at screening;&#xD;
&#xD;
          -  Presence or history of gastrointestinal, hepatic or renal disease, or any other&#xD;
             condition (including surgery) known to interfere with the absorption, distribution,&#xD;
             metabolism, or excretion of medicines;&#xD;
&#xD;
          -  Systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure&#xD;
             outside the range of 40 to 90 mmHg, and/or pulse rate outside the range of 40 to 100&#xD;
             beats per minute after one repeat at screening or check-in;&#xD;
&#xD;
          -  Abnormal ECG at screening as judged by the Investigator;&#xD;
&#xD;
          -  History of clinically significant drug and/or food allergies as determined by the&#xD;
             Investigator;&#xD;
&#xD;
          -  Allergy to sesame, sesame oil, or a history of hypersensitivity or idiosyncratic&#xD;
             reaction to compounds related to the study drug&#xD;
&#xD;
          -  Subjects undergoing current treatment with other androgens (i.e.&#xD;
             dehydroepiandrosterone [DHEA]), anabolic steroids, other sex hormones, or drugs that&#xD;
             interfere with the metabolism of testosterone (i.e. opioids, anastrozole, clomiphene,&#xD;
             dutasteride, finasteride, flutamide, ketoconazole, spironolactone, and testolactone);&#xD;
&#xD;
          -  Subjects treated within the past 12 months with estrogens, gonadotropin releasing&#xD;
             hormone (GnRH) agonists, or growth hormone;&#xD;
&#xD;
          -  Prescription, over the counter medications, vitamins, herbal and dietary supplements&#xD;
             taken within 7 days or 5 half-lives (whichever is longer) prior to the dose of study&#xD;
             medication and duration of the study;&#xD;
&#xD;
          -  Positive screen for human immunodeficiency virus (HIV), hepatitis B, and/or hepatitis&#xD;
             C at screening;&#xD;
&#xD;
          -  Positive urine screen for drugs of abuse (amphetamine, barbiturates, benzodiazepines,&#xD;
             cocaine, marijuana, methadone, methamphetamines, oxycodone, and opiates) or positive&#xD;
             breath alcohol test at screening and check-in&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Male</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>Jonathan Jaffe, MD</last_name>
    <role>Study Director</role>
    <affiliation>Antares Pharma Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medpace Clinical Pharmacology Unit</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45227</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>September 2, 2014</study_first_submitted>
  <study_first_submitted_qc>September 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 8, 2014</study_first_posted>
  <results_first_submitted>December 19, 2017</results_first_submitted>
  <results_first_submitted_qc>January 18, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">April 19, 2019</results_first_posted>
  <last_update_submitted>January 18, 2019</last_update_submitted>
  <last_update_submitted_qc>January 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 19, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Healthy Adult Males</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypogonadism</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Methyltestosterone</mesh_term>
    <mesh_term>Testosterone</mesh_term>
    <mesh_term>Testosterone undecanoate</mesh_term>
    <mesh_term>Testosterone enanthate</mesh_term>
    <mesh_term>Testosterone 17 beta-cypionate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Pharmacokinetics of single doses of Testosterone Enanthate administered via a drug-auto injector combination product in Healthy Male Subjects</recruitment_details>
      <pre_assignment_details>Two dose groups, Testosterone Enanthate 50 mg and Testosterone Enanthate 200 mg , were evaluated in parallel with 6 subjects in each dose group.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Testosterone Enanthate 50 mg</title>
          <description>Testosterone enanthate auto-injector&#xD;
50 mg SC injection</description>
        </group>
        <group group_id="P2">
          <title>Testosterone Enanthate 200 mg</title>
          <description>Testosterone enanthate auto-injector&#xD;
200 mg SC injection</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>In total, 12 subjects were administered study drug: 6 subjects received 50 mg SC QST and 6 subjects received 200 mg SC QST. There were no discontinuations in the study.</population>
      <group_list>
        <group group_id="B1">
          <title>Testosterone Enanthate 50 mg</title>
          <description>Testosterone enanthate auto-injector 50 mg</description>
        </group>
        <group group_id="B2">
          <title>Testosterone Enanthate 200 mg</title>
          <description>Testosterone enanthate auto-injector 200 mg</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="6"/>
            <count group_id="B2" value="6"/>
            <count group_id="B3" value="12"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="38.0" spread="11.54"/>
                    <measurement group_id="B2" value="37.5" spread="10.84"/>
                    <measurement group_id="B3" value="37.8" spread="10.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Maximum Concentration (Cmax) for Serum Testosterone and Testosterone Enanthate</title>
        <description>Cmax = Maximum blood concentration (ng/dL) of TT=Total Testosterone and TE=Testosterone Enanthate</description>
        <time_frame>Maximum serum concentrations occurring during an 8 days study window</time_frame>
        <population>Healthy normal male volunteers</population>
        <group_list>
          <group group_id="O1">
            <title>Testosterone Enanthate 50 mg</title>
            <description>Testosterone enanthate auto-injector 50 mg</description>
          </group>
          <group group_id="O2">
            <title>Testosterone Enanthate 200 mg</title>
            <description>Testosterone enanthate auto-injector 200 mg</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Concentration (Cmax) for Serum Testosterone and Testosterone Enanthate</title>
          <description>Cmax = Maximum blood concentration (ng/dL) of TT=Total Testosterone and TE=Testosterone Enanthate</description>
          <population>Healthy normal male volunteers</population>
          <units>ng/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Serum testosterone</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="773.7" spread="121.26"/>
                    <measurement group_id="O2" value="1487.0" spread="405.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serum testosterone enanthate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49.25" spread="6.90"/>
                    <measurement group_id="O2" value="267.33" spread="75.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Area Under the Concentration-time Curve From Time Zero to Time t</title>
        <description>AUC(0-168h) (ng⋅hr/dL) = area under the concentration-time curve from time zero to Day 8 (1 week);</description>
        <time_frame>168 hrs</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Testosterone Enanthate 50 mg</title>
            <description>Testosterone enanthate auto-injector 50 mg</description>
          </group>
          <group group_id="O2">
            <title>Testosterone Enanthate 200 mg</title>
            <description>Testosterone enanthate auto-injector 200 mg</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Concentration-time Curve From Time Zero to Time t</title>
          <description>AUC(0-168h) (ng⋅hr/dL) = area under the concentration-time curve from time zero to Day 8 (1 week);</description>
          <units>(ng⋅hr/dL)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>TT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="103731.5" spread="12591.81"/>
                    <measurement group_id="O2" value="176112.8" spread="47349.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6122.2" spread="929.12"/>
                    <measurement group_id="O2" value="33535.5" spread="9977.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Area Under the Concentration-time Curve From Time Zero to Infinity</title>
        <description>AUC(0-inf) (ng⋅hr/dL) = area under the concentration-time curve from time zero to infinity</description>
        <time_frame>time zero to infinity</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Testosterone Enanthate 50 mg</title>
            <description>Testosterone enanthate auto-injector 50 mg</description>
          </group>
          <group group_id="O2">
            <title>Testosterone Enanthate 200 mg</title>
            <description>Testosterone enanthate auto-injector 200 mg</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Concentration-time Curve From Time Zero to Infinity</title>
          <description>AUC(0-inf) (ng⋅hr/dL) = area under the concentration-time curve from time zero to infinity</description>
          <units>(ng⋅hr/dL)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>TT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="279062.2" spread="35973.32"/>
                    <measurement group_id="O2" value="362627.4" spread="138773.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">AUC(0-inf) is not calculated when the constant lambda z is not assigned, which occurs if the terminal elimination phase is not linear, if the tmax is one of the 3 last data points, or if the regression coefficient is &lt;0.8.</measurement>
                    <measurement group_id="O2" value="62497.5" spread="24618.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Maximum Concentration (Tmax)(hr)</title>
        <description>tmax = Time to reach maximum concentration</description>
        <time_frame>The sample time of Cmax during a 168 hour sampling interval</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Testosterone Enanthate 50 mg</title>
            <description>Testosterone enanthate auto-injector 50 mg</description>
          </group>
          <group group_id="O2">
            <title>Testosterone Enanthate 200 mg</title>
            <description>Testosterone enanthate auto-injector 200 mg</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Maximum Concentration (Tmax)(hr)</title>
          <description>tmax = Time to reach maximum concentration</description>
          <units>hours</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>TT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.51" spread="52.95"/>
                    <measurement group_id="O2" value="19.00" spread="7.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.01" spread="53.88"/>
                    <measurement group_id="O2" value="74.00" spread="57.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Half-life (t 1/2)(hr)</title>
        <description>t 1/2 = Half-life is the time required for a concentration to reduce to half its initial value</description>
        <time_frame>168 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Testosterone Enanthate 50 mg</title>
            <description>Testosterone enanthate auto-injector 50 mg</description>
          </group>
          <group group_id="O2">
            <title>Testosterone Enanthate 200 mg</title>
            <description>Testosterone enanthate auto-injector 200 mg</description>
          </group>
        </group_list>
        <measure>
          <title>Half-life (t 1/2)(hr)</title>
          <description>t 1/2 = Half-life is the time required for a concentration to reduce to half its initial value</description>
          <units>hours</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>TT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="261.73" spread="99.04"/>
                    <measurement group_id="O2" value="131.75" spread="28.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Half-life (t 1/2) is not calculated when the constant lambda z is not assigned, which occurs if the terminal elimination phase is not linear, if the tmax is one of the 3 last data points, or if the regression coefficient is &lt;0.8.</measurement>
                    <measurement group_id="O2" value="133.00" spread="67.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Clearance CL/F (L/hr)</title>
        <description>Clearance - volume of plasma from which TT/TE is completely removed per unit time</description>
        <time_frame>168 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Testosterone Enanthate 50 mg</title>
            <description>Testosterone enanthate auto-injector 50 mg</description>
          </group>
          <group group_id="O2">
            <title>Testosterone Enanthate 200 mg</title>
            <description>Testosterone enanthate auto-injector 200 mg</description>
          </group>
        </group_list>
        <measure>
          <title>Clearance CL/F (L/hr)</title>
          <description>Clearance - volume of plasma from which TT/TE is completely removed per unit time</description>
          <units>L/hr</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>TT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.07" spread="2.33"/>
                    <measurement group_id="O2" value="60.46" spread="21.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Clearance - CL/F is not calculated when the constant lambda z is not assigned, which occurs if the terminal elimination phase is not linear, if the tmax is one of the 3 last data points, or if the regression coefficient is &lt;0.8.</measurement>
                    <measurement group_id="O2" value="352.84" spread="127.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Vd/F (L)</title>
        <description>Vd/F (L) = Apparent volume of distribution</description>
        <time_frame>168 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Testosterone Enanthate 50 mg</title>
            <description>Testosterone enanthate auto-injector 50 mg</description>
          </group>
          <group group_id="O2">
            <title>Testosterone Enanthate 200 mg</title>
            <description>Testosterone enanthate auto-injector 200 mg</description>
          </group>
        </group_list>
        <measure>
          <title>Vd/F (L)</title>
          <description>Vd/F (L) = Apparent volume of distribution</description>
          <units>Liters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>TT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6655.8" spread="1702.04"/>
                    <measurement group_id="O2" value="10959.5" spread="2040.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Vd/F is not calculated when the constant lambda z is not assigned, which occurs if the terminal elimination phase is not linear, if the tmax is one of the 3 last data points, or if the regression coefficient is &lt;0.8.</measurement>
                    <measurement group_id="O2" value="62366.4" spread="23950.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>14 days</time_frame>
      <desc>Safety assessments included adverse events and injection site assessments.</desc>
      <group_list>
        <group group_id="E1">
          <title>Treatment A</title>
          <description>Testosterone enanthate auto-injector (SC injection) Treatment A</description>
        </group>
        <group group_id="E2">
          <title>Treatment B</title>
          <description>Testosterone enanthate auto-injector (SC injections) Treatment B</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>2</frequency_threshold>
        <default_vocab>MedDRA 10.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Injection site pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Jonathan Jaffe, MD</name_or_title>
      <organization>Antares Pharma, Inc.</organization>
      <phone>609-359-3020</phone>
      <email>jjaffe@antarespharma.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02233751
org study id: QST-14-004
nct id: NCT02233751
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: Yes
is unapproved device: Yes
Evaluation of pharmacokinetics of subcutaneous testosterone enanthate
Evaluation of pharmacokinetics and safety profile of testosterone enanthate injected
      subcutaneously via auto-injector in healthy male volunteers
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
masking description: The dose assignment was random among the enrolled participants.
measure: Maximum Concentration (Cmax) for Serum Testosterone and Testosterone Enanthate
time frame: Maximum serum concentrations occurring during an 8 days study window
description: Cmax = Maximum blood concentration (ng/dL) of TT=Total Testosterone and TE=Testosterone Enanthate
measure: Area Under the Concentration-time Curve From Time Zero to Time t
time frame: 168 hrs
description: AUC(0-168h) (ng⋅hr/dL) = area under the concentration-time curve from time zero to Day 8 (1 week);
measure: Area Under the Concentration-time Curve From Time Zero to Infinity
time frame: time zero to infinity
description: AUC(0-inf) (ng⋅hr/dL) = area under the concentration-time curve from time zero to infinity
measure: Time to Maximum Concentration (Tmax)(hr)
time frame: The sample time of Cmax during a 168 hour sampling interval
description: tmax = Time to reach maximum concentration
measure: Half-life (t 1/2)(hr)
time frame: 168 hours
description: t 1/2 = Half-life is the time required for a concentration to reduce to half its initial value
measure: Clearance CL/F (L/hr)
time frame: 168 hours
description: Clearance - volume of plasma from which TT/TE is completely removed per unit time
measure: Vd/F (L)
time frame: 168 hours
description: Vd/F (L) = Apparent volume of distribution
arm group label: Testosterone enanthate auto-injector - 50 mg
arm group type: Experimental
description: Testosterone enanthate auto-injector - 50 mg (SC injection)
arm group label: Testosterone enanthate auto-injector - 200 mg
arm group type: Experimental
description: Testosterone enanthate auto-injector- 200 mg (SC injection)
intervention type: Combination Product
intervention name: Testosterone enanthate auto-injector
description: Randomization then administration of combination product study medication according to group assignment
arm group label: Testosterone enanthate auto-injector - 200 mg
arm group label: Testosterone enanthate auto-injector - 50 mg
criteria: 
gender: Male
gender based: Yes
gender description: Male
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jonathan Jaffe, MD
role: Study Director
affiliation: Antares Pharma Inc.
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hypogonadism
mesh term: Methyltestosterone
mesh term: Testosterone
mesh term: Testosterone undecanoate
mesh term: Testosterone enanthate
mesh term: Testosterone 17 beta-cypionate
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 