<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/NCT02202408</url>
  </required_header>
  <id_info>
    <org_study_id>SKI2670_EMSD_I_2013</org_study_id>
    <nct_id>NCT02202408</nct_id>
  </id_info>
  <brief_title>Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of SKI2670</brief_title>
  <official_title>A Phase I, Double-blind, Randomized, Placebo-controlled, Single-Dose Escalation, First-in-human Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SKI2670</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>SK Chemicals Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>SK Chemicals Co., Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this Phase I study, the primary objective is to investigate the safety and tolerability of&#xD;
      SKI2670 after oral administration in healthy female subjects. And secondary objective is to&#xD;
      investigate the pharmacokinetics and pharmacodynamics of SKI2670 after oral administration in&#xD;
      healthy female subjects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this Phase I study, the primary objective is to investigate the safety and tolerability of&#xD;
      SKI2670 after oral administration in healthy female subjects.&#xD;
&#xD;
      Secondary objective is to investigate the pharmacokinetics and pharmacodynamics of SKI2670&#xD;
      after oral administration in healthy female subjects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">August 2016</completion_date>
  <primary_completion_date type="Actual">August 2016</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants with Adverse Events as a Measure of Safety and Tolerability</measure>
    <time_frame>From day 1 to day 16~26D after a single oral dose.</time_frame>
    <description>All participants who ever were administered with investigational product are assessed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Peak Plasma Concentration (Cmax) of SKI2670</measure>
    <time_frame>0h(pre-dose), 10min, 20min, 30min, 45min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h</time_frame>
    <description>Peak Plasma Concentration (Cmax) of SKI2670</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under Curve (AUC) of SKI2670</measure>
    <time_frame>0h(pre-dose), 10min, 20min, 30min, 45min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h</time_frame>
    <description>Area Under Curve (AUC) of SKI2670</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concentration Change from Baseline(%) of Luteinizing Hormone (LH)</measure>
    <time_frame>day -1, 0h(pre-dose), 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 30h, 36h, 48h, 72h, day 7~12D, 16~26D</time_frame>
    <description>Concentration Change from Baseline(%) of Luteinizing Hormone (LH)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Endometriosis</condition>
  <arm_group>
    <arm_group_label>SKI2670</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single-dose escalation/ Subjects received an oral single dose of SKI2670 capsule by dosing group&#xD;
-Dosing Group 1, Dosing Group 2, Dosing Group 3, Dosing Group 4</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subjects received an oral single dose of placebo capsule matched to the SKI2670 dose (Placebo for SKI2670)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SKI2670</intervention_name>
    <description>Oral, Single Dose</description>
    <arm_group_label>SKI2670</arm_group_label>
    <other_name>N/A(only SKI2670)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Same shape as the experimental drug</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>N/A(only 1 Placebo)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Female, 20 years of age and older&#xD;
&#xD;
          2. Weight between 40kg~70kg&#xD;
&#xD;
          3. Women who agreed using double contraception method and spermicide, avoiding&#xD;
             breast-feeding for at least 30days after IP(investigational product) dosing&#xD;
&#xD;
          4. A history of regular menstrual cycles (cycle: 28±7day, duration: 2~7day) for at least&#xD;
             2 years and a positive ovulation test between day 11 and 21 in the preceding menstrual&#xD;
             cycle of IP(investigational product) dosing&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Women who are pregnant or serum/urine hCG(human chorionic gonadotropin) positive or&#xD;
             breast-feeding&#xD;
&#xD;
          2. A history of breast cancer, genital cancer or any estrogen dependent tumor&#xD;
&#xD;
          3. Specified or unspecified diagnosed infertility or history of natural abortion over&#xD;
             three times&#xD;
&#xD;
          4. A history of taking other Investigational product within 60days before screening visit&#xD;
             or taking ETC drug(Ethical drugs), oriental medicine or OTC drugs(Over-the-Counter&#xD;
             drugs) within 14days before screening visit&#xD;
&#xD;
          5. Clinically significant Gynecological disease identified by ultrasonography including&#xD;
             estrogen dependent tumor or lesion, sever inflammation or synechia&#xD;
&#xD;
          6. AST(Aspartate aminotransferase), ALT(Alanine aminotransferase) ≥ 2.5 times the upper&#xD;
             limit of normal&#xD;
&#xD;
          7. QTc &gt; 450ms on electrocardiogram result&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kyun-Seop Bae, MD,PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Asan Medical Center Department of Clinical Pharmacology and Therapeutics</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>138-736</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>July 16, 2014</study_first_submitted>
  <study_first_submitted_qc>July 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 29, 2014</study_first_posted>
  <last_update_submitted>October 18, 2017</last_update_submitted>
  <last_update_submitted_qc>October 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 20, 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>Endometriosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02202408
org study id: SKI2670_EMSD_I_2013
nct id: NCT02202408
lead sponsor: 
has dmc: No
In this Phase I study, the primary objective is to investigate the safety and tolerability of
      SKI2670 after oral administration in healthy female subjects. And secondary objective is to
      investigate the pharmacokinetics and pharmacodynamics of SKI2670 after oral administration in
      healthy female subjects.
In this Phase I study, the primary objective is to investigate the safety and tolerability of
      SKI2670 after oral administration in healthy female subjects.

      Secondary objective is to investigate the pharmacokinetics and pharmacodynamics of SKI2670
      after oral administration in healthy female subjects.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
time frame: From day 1 to day 16~26D after a single oral dose.
description: All participants who ever were administered with investigational product are assessed.
measure: Peak Plasma Concentration (Cmax) of SKI2670
time frame: 0h(pre-dose), 10min, 20min, 30min, 45min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h
description: Peak Plasma Concentration (Cmax) of SKI2670
measure: Area Under Curve (AUC) of SKI2670
time frame: 0h(pre-dose), 10min, 20min, 30min, 45min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h
description: Area Under Curve (AUC) of SKI2670
measure: Concentration Change from Baseline(%) of Luteinizing Hormone (LH)
time frame: day -1, 0h(pre-dose), 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 30h, 36h, 48h, 72h, day 7~12D, 16~26D
description: Concentration Change from Baseline(%) of Luteinizing Hormone (LH)
arm group label: SKI2670
arm group type: Experimental
description: Single-dose escalation/ Subjects received an oral single dose of SKI2670 capsule by dosing group
-Dosing Group 1, Dosing Group 2, Dosing Group 3, Dosing Group 4
arm group label: Placebo
arm group type: Placebo Comparator
description: Subjects received an oral single dose of placebo capsule matched to the SKI2670 dose (Placebo for SKI2670)
intervention type: Drug
intervention name: SKI2670
description: Oral, Single Dose
arm group label: SKI2670
other name: N/A(only SKI2670)
intervention type: Drug
intervention name: Placebo
description: Same shape as the experimental drug
arm group label: Placebo
other name: N/A(only 1 Placebo)
criteria: 
gender: Female
minimum age: 20 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Kyun-Seop Bae, MD,PhD
role: Study Chair
affiliation: Asan Medical Center Department of Clinical Pharmacology and Therapeutics
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Endometriosis
sharing ipd: Undecided