<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/NCT03029533</url>
  </required_header>
  <id_info>
    <org_study_id>DW_LP3M002</org_study_id>
    <nct_id>NCT03029533</nct_id>
  </id_info>
  <brief_title>Phase 1 Study to Evaluate the Pharmacokinetics and Safety Following SC Administration of DWJ108J in Patients With Prostate Cancer</brief_title>
  <official_title>An Open Label, Randomized, Single Dose, Parallel-group, Phase 1 Study to Evaluate the Pharmacokinetics and Safety Following Subcutaneous Administration of DWJ108J in Patients With Prostate Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Daewoong Pharmaceutical Co. LTD.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Daewoong Pharmaceutical Co. LTD.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the pharmacokinetic characteristics and safety of&#xD;
      DWJ108J (leuprolide acetate) and Leuplin DPS Inj administered subcutaneously in patients with&#xD;
      prostate cancer&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>February 2017</start_date>
  <primary_completion_date type="Anticipated">November 2017</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>
  </study_design_info>
  <primary_outcome>
    <measure>Peak Plasma Concentration (Cmax)</measure>
    <time_frame>Day 99</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the plasma concentration versus time curve (AUC)</measure>
    <time_frame>Day 99</time_frame>
    <description>AUC0-7, AUC7-28, AUC 0-42, AUCt, AUCinf</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">44</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>DWJ108J (leuprolide acetate)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>DWJ108J (leuprolide acetate)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Leuplin DPS Inj</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Leuplin DPS Inj</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Leuprolide Acetate</intervention_name>
    <description>DWJ108J, SC injection, once(Day1)</description>
    <arm_group_label>DWJ108J (leuprolide acetate)</arm_group_label>
    <other_name>DWJ108J</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Leuprolide Acetate</intervention_name>
    <description>Leuplin DPS Inj, SC injection, once(Day1)</description>
    <arm_group_label>Leuplin DPS Inj</arm_group_label>
    <other_name>Leuplin DPS Inj</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Males ≥19 and ≤80 years of age at Screening.&#xD;
&#xD;
          2. Subject with histologically proven adenocarcinoma of the prostate requiring androgen&#xD;
             deprivation therapy&#xD;
&#xD;
          3. An ECOG performance status grade of 0 to 2,&#xD;
&#xD;
          4. 19kg/m2≤ Body Mass Index (BMI) ≤30kg/m2 at Screening.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Confirmed Hormone refractory prostate cancer(HRPC)&#xD;
&#xD;
          2. Has had history of bilateral orchiectomy, suprarenalectomy or hypophysectomy.&#xD;
&#xD;
          3. Diagnosed pituitary adenoma&#xD;
&#xD;
          4. Has a history of depression&#xD;
&#xD;
          5. Has a risk of spinal cor d compression due to metastatic spinal cord injury.&#xD;
&#xD;
          6. Has a severe urethratresia.&#xD;
&#xD;
          7. Confirmed uncontrolled Congestive heart failure (CHF) within 6 months of Screening.&#xD;
&#xD;
          8. Has a history of MI or any procedure with regard to coronary artery disease within 6&#xD;
             months of Screening. (e.g., balloon angioplasty, coronary artery bypass graft)&#xD;
&#xD;
          9. Has any severe concomitant disease that would interfere with the conduct of the study&#xD;
             except for prostate cancer&#xD;
&#xD;
         10. Has allergy history of leuprolide acetate, similar GnRH drugs or other medications&#xD;
             (e.g., Aspirin, antibiotics) and/or has any allergic disease requiring treatment.&#xD;
&#xD;
         11. Has received an investigational drug within 9 0days of Screening.&#xD;
&#xD;
         12. Drug releasing is expected after administration of study drug, if subject received&#xD;
             GnRH agonist for treatment of prostate cancer.&#xD;
&#xD;
         13. Has other chemotherapy planned within 14weeks from administration of study drug,&#xD;
             except for androgen deprivation therapy.&#xD;
&#xD;
         14. Has no willing of using method of contraception throughout the study period.&#xD;
&#xD;
         15. Systolic Blood Pressure &lt; 90mmHg and/or ≥160mmHg or Diastolic Blood Pressure &lt; 60mmHg&#xD;
             and/or ≥100mmHg at Screening&#xD;
&#xD;
         16. QTcF &gt;450msec at Screening ECG.&#xD;
&#xD;
         17. HbA1c level is high the upper limit of normal of reference range.&#xD;
&#xD;
         18. Serum AST, ALT or Creatinine &gt; 1.5times the upper limit of normal at Screening.&#xD;
&#xD;
         19. Positive results of tests for hepatitis B, hepatitis C, HIV or syphilis.&#xD;
&#xD;
         20. Has any condition that, in the opinion of the investigator, would make participation&#xD;
             not be in the best interest of the subject.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 12, 2017</study_first_submitted>
  <study_first_submitted_qc>January 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 24, 2017</study_first_posted>
  <last_update_submitted>January 20, 2017</last_update_submitted>
  <last_update_submitted_qc>January 20, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leuprolide</mesh_term>
  </intervention_browse>
  <!-- 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/NCT03029533
org study id: DW_LP3M002
nct id: NCT03029533
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the pharmacokinetic characteristics and safety of
      DWJ108J (leuprolide acetate) and Leuplin DPS Inj administered subcutaneously in patients with
      prostate cancer
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Peak Plasma Concentration (Cmax)
time frame: Day 99
measure: Area under the plasma concentration versus time curve (AUC)
time frame: Day 99
description: AUC0-7, AUC7-28, AUC 0-42, AUCt, AUCinf
arm group label: DWJ108J (leuprolide acetate)
arm group type: Experimental
description: DWJ108J (leuprolide acetate)
arm group label: Leuplin DPS Inj
arm group type: Active Comparator
description: Leuplin DPS Inj
intervention type: Drug
intervention name: Leuprolide Acetate
description: DWJ108J, SC injection, once(Day1)
arm group label: DWJ108J (leuprolide acetate)
other name: DWJ108J
intervention type: Drug
intervention name: Leuprolide Acetate
description: Leuplin DPS Inj, SC injection, once(Day1)
arm group label: Leuplin DPS Inj
other name: Leuplin DPS Inj
criteria: 
gender: Male
minimum age: 19 Years
maximum age: 80 Years
healthy volunteers: No
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
mesh term: Leuprolide