<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/NCT03233932</url>
  </required_header>
  <id_info>
    <org_study_id>155HPS14022</org_study_id>
    <nct_id>NCT03233932</nct_id>
  </id_info>
  <brief_title>CKD-841 Pharmacokinetic/Pharmacodynamic Study</brief_title>
  <official_title>Clinical Trial to Investigate the Safety and Pharmacokinetics/Pharmacodynamics of CKD-841 After Subcutaneous Injection in Postmenopausal Female</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chong Kun Dang Pharmaceutical</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Severance Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Chong Kun Dang Pharmaceutical</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A randomized, open-label, single dose, parallel design phase I clinical trial to investigate&#xD;
      the safety and pharmacokinetic/pharmacodynamics of CKD-841 or Leuplin Inj. 3.75mg after&#xD;
      subcutaneous injection in postmenopausal female.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To investigate the safety and pharmacokinetic/pharmacodynamics of CKD-841 or Leuplinⓡ Inj.&#xD;
      3.75mg after subcutaneous injection in postmenopausal female is the purpose of this trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 2016</start_date>
  <completion_date type="Actual">July 2017</completion_date>
  <primary_completion_date type="Actual">July 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) of Leuprorelin</measure>
    <time_frame>From before injection to up to 1008 hours post injection</time_frame>
    <description>Peak Plasma Concentration (Cmax) in ng/mL</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the plasma drug Concentration-time curve to last measurement (AUClast ) of Leuprorelin</measure>
    <time_frame>From before injection to up to 1008 hours post injection</time_frame>
    <description>Area Under the plasma drug Concentration-time curve to last measurement (AUClast ) in ng•hr/mL</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the plasma drug Concentration-time curve extrapolated to infinity (AUCinf) of Leuprorelin</measure>
    <time_frame>From before injection to up to 1008 hours post injection</time_frame>
    <description>Area Under the plasma drug Concentration-time curve extrapolated to infinity (AUCinf) in ng•hr/mL</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the plasma drug Concentration-time curve from 7 day to last measurement (AUC7-t) of Leuprorelin</measure>
    <time_frame>From before injection to up to 1008 hours post injection</time_frame>
    <description>Area Under the plasma drug Concentration-time curve from 7 day to last measurement (AUC7-t) in ng•hr/mL</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The time -to-maximal serum or plasma concentrations (Tmax) of Leuprorelin</measure>
    <time_frame>From before injection to up to 1008 hours post injection</time_frame>
    <description>The time -to-maximal serum or plasma concentrations (Tmax) in hr</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Terminal half-life (t1/2) Luteinizing Hormone(LH) of Leuprorelin</measure>
    <time_frame>From before injection to up to 1008 hours post injection</time_frame>
    <description>Terminal half-life (t1/2) Luteinizing Hormone(LH) in IU/L</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Follicular Stimulating Hormone(FSH) of Leuprorelin</measure>
    <time_frame>From before injection to up to 1008 hours post injection</time_frame>
    <description>Follicular Stimulating Hormone(FSH) in IU/L</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Estradiol of Leuprorelin</measure>
    <time_frame>From before injection to up to 1008 hours post injection</time_frame>
    <description>Estradiol in pg/ml</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety Assessment by evaluating adverse events(AEs).</measure>
    <time_frame>From day1 to day 56</time_frame>
    <description>Assessment of the safety of subjects by evaluating adverse events(AEs).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">13</enrollment>
  <condition>Postmenopausal Disorder</condition>
  <arm_group>
    <arm_group_label>LeuplinⓡInj</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>LeuplinⓡInj(=leuprorelin acetate 3.75mg)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CKD-841</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CKD-841(=leuprorelin acetate 3.75mg)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LeuplinⓡInj</intervention_name>
    <description>Investigational drug(=LeuplinⓡInj)is prescribed single injection dose by subcutaneous to 6 of randomized subjects once.</description>
    <arm_group_label>LeuplinⓡInj</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CKD-841</intervention_name>
    <description>Investigational drug(=CDK-841) is prescribed single injection dose by subcutaneous to 6 of randomized subjects once.</description>
    <arm_group_label>CKD-841</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy menopausal female&#xD;
&#xD;
          -  β-hCG is negative at screening and before administration of investigational drug&#xD;
&#xD;
          -  Infertility by sterilization operation before 5 months from screening excluding&#xD;
             ovarian cancer, uterine cancer etc...&#xD;
&#xD;
          -  Bwt ≥ 50Kg and Body Mass Index (BMI) ≥ 18.5 and &lt; 25&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History or current condition of disease related to Hepato-biliary system, renal&#xD;
             system, nervous system, mental illness, immune system, respiratory system, endocrine&#xD;
             system, hemato-oncology, circulatory system, musculoskeletal system or except for&#xD;
             that, significant clinical disease&#xD;
&#xD;
          -  Uncontrolled diabetes mellitus&#xD;
&#xD;
          -  Pregnancy or breast feeding&#xD;
&#xD;
          -  History of taking medicine such as Leuprorelin acetate or similar affiliation drug&#xD;
             within 12 weeks before administration of investigational drug&#xD;
&#xD;
          -  Has hypersensitivity to the active ingredient or excipients or same affiliation drug&#xD;
             of the investigational drug, hypersensitivity of a medicine contained gelatin&#xD;
             especially&#xD;
&#xD;
          -  Has abnormal function of liver and kidney at screening&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Min Soo Park, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Severance Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Severance Hospital</name>
      <address>
        <city>Seoul</city>
        <state>Yonsei-ro, Seodaemun-gu 50-1</state>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>May 23, 2016</study_first_submitted>
  <study_first_submitted_qc>July 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2017</study_first_posted>
  <last_update_submitted>July 26, 2017</last_update_submitted>
  <last_update_submitted_qc>July 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 31, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>CKD-841</keyword>
  <keyword>Leuplin</keyword>
  <keyword>Postmenopausal</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leuprolide</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03233932
org study id: 155HPS14022
nct id: NCT03233932
lead sponsor: 
collaborator: 
has dmc: No
A randomized, open-label, single dose, parallel design phase I clinical trial to investigate
      the safety and pharmacokinetic/pharmacodynamics of CKD-841 or Leuplin Inj. 3.75mg after
      subcutaneous injection in postmenopausal female.
To investigate the safety and pharmacokinetic/pharmacodynamics of CKD-841 or Leuplinⓡ Inj.
      3.75mg after subcutaneous injection in postmenopausal female is the purpose of this trial.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Peak Plasma Concentration (Cmax) of Leuprorelin
time frame: From before injection to up to 1008 hours post injection
description: Peak Plasma Concentration (Cmax) in ng/mL
measure: Area Under the plasma drug Concentration-time curve to last measurement (AUClast ) of Leuprorelin
time frame: From before injection to up to 1008 hours post injection
description: Area Under the plasma drug Concentration-time curve to last measurement (AUClast ) in ng•hr/mL
measure: Area Under the plasma drug Concentration-time curve extrapolated to infinity (AUCinf) of Leuprorelin
time frame: From before injection to up to 1008 hours post injection
description: Area Under the plasma drug Concentration-time curve extrapolated to infinity (AUCinf) in ng•hr/mL
measure: Area Under the plasma drug Concentration-time curve from 7 day to last measurement (AUC7-t) of Leuprorelin
time frame: From before injection to up to 1008 hours post injection
description: Area Under the plasma drug Concentration-time curve from 7 day to last measurement (AUC7-t) in ng•hr/mL
measure: The time -to-maximal serum or plasma concentrations (Tmax) of Leuprorelin
time frame: From before injection to up to 1008 hours post injection
description: The time -to-maximal serum or plasma concentrations (Tmax) in hr
measure: Terminal half-life (t1/2) Luteinizing Hormone(LH) of Leuprorelin
time frame: From before injection to up to 1008 hours post injection
description: Terminal half-life (t1/2) Luteinizing Hormone(LH) in IU/L
measure: Follicular Stimulating Hormone(FSH) of Leuprorelin
time frame: From before injection to up to 1008 hours post injection
description: Follicular Stimulating Hormone(FSH) in IU/L
measure: Estradiol of Leuprorelin
time frame: From before injection to up to 1008 hours post injection
description: Estradiol in pg/ml
measure: Safety Assessment by evaluating adverse events(AEs).
time frame: From day1 to day 56
description: Assessment of the safety of subjects by evaluating adverse events(AEs).
arm group label: LeuplinⓡInj
arm group type: Active Comparator
description: LeuplinⓡInj(=leuprorelin acetate 3.75mg)
arm group label: CKD-841
arm group type: Experimental
description: CKD-841(=leuprorelin acetate 3.75mg)
intervention type: Drug
intervention name: LeuplinⓡInj
description: Investigational drug(=LeuplinⓡInj)is prescribed single injection dose by subcutaneous to 6 of randomized subjects once.
arm group label: LeuplinⓡInj
intervention type: Drug
intervention name: CKD-841
description: Investigational drug(=CDK-841) is prescribed single injection dose by subcutaneous to 6 of randomized subjects once.
arm group label: CKD-841
criteria: 
gender: Female
minimum age: 40 Years
maximum age: 65 Years
healthy volunteers: No
last name: Min Soo Park, Ph.D
role: Principal Investigator
affiliation: Severance Hospital
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Leuprolide
sharing ipd: No