<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/NCT02205099</url>
  </required_header>
  <id_info>
    <org_study_id>SKL15508C003</org_study_id>
    <nct_id>NCT02205099</nct_id>
  </id_info>
  <brief_title>A Safety, Tolerability, PK and PD Study of Multiple Oral Doses of SKL15508 in Subjects With Stable Schizophrenia</brief_title>
  <official_title>A Single-center, Randomized, Double-blind, Flexible-dosage, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of Multiple Oral Doses of SKL15508 in Subjects With Stable Schizophrenia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>SK Life Science, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>SK Life Science, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a single-site, randomized, double-blind, placebo-controlled, multiple dose, flexible&#xD;
      dosage range, PK and PD study of SKL15508 as monotherapy in subjects with stable&#xD;
      schizophrenia.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</primary_completion_date>
  <phase>Phase 1/Phase 2</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number and percent of subjects experiencing an adverse event.</measure>
    <time_frame>10 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in event-related potentials (ERP) following multiple oral doses of SKL15508.</measure>
    <time_frame>During the course of 10 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in clinical laboratory assessments.</measure>
    <time_frame>10 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in vital signs.</measure>
    <time_frame>10 days</time_frame>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">39</enrollment>
  <condition>Schizophrenia</condition>
  <arm_group>
    <arm_group_label>SKL15508 High Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SKL15508 High Dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SKL15508 Medium Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SKL15508 Medium Dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SKL15508 Low Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SKL15508 Low Dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SKL15508</intervention_name>
    <arm_group_label>SKL15508 High Dose</arm_group_label>
    <arm_group_label>SKL15508 Low Dose</arm_group_label>
    <arm_group_label>SKL15508 Medium Dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. The subject or, when applicable, the subject's legally acceptable representative signs&#xD;
             and dates a written, informed consent form and any required privacy authorization&#xD;
             prior to the initiation of any study procedures.&#xD;
&#xD;
          2. Participants who are nonsterile and sexually active agree to use a double-barrier&#xD;
             method of contraception (must be used regardless of any other contraception in use)&#xD;
             from the time of providing informed consent throughout the duration of the study and&#xD;
             for 12 weeks after the last dose of study drug. Nonsterile males must be advised not&#xD;
             to donate sperm and women should not donate ova throughout the duration of the study&#xD;
             and for 12 weeks after the last dose of study drug.&#xD;
&#xD;
          3. Must be male or non-pregnant, non-lactating female subjects, 18 to 60 years of age,&#xD;
             inclusive&#xD;
&#xD;
          4. Has a body mass index (BMI) between 18.0 and 38.0 kg/m2, inclusive&#xD;
&#xD;
          5. Has a clinical diagnosis of schizophrenia and, in the opinion of the Investigator, is&#xD;
             able to safely be off his or her prescribed antipsychotic medications while&#xD;
             participating in the study and has a very high likelihood of not deteriorating over a&#xD;
             3-week timeframe when off standard of care as outpatients during the Screening Period&#xD;
&#xD;
          6. Has been receiving a stable dose of antipsychotic medication for at least 1 month&#xD;
             before Screening&#xD;
&#xD;
          7. Has not had an acute exacerbation of psychosis or hospitalization for the treatment of&#xD;
             schizophrenia for at least 3 months before Screening&#xD;
&#xD;
          8. By history, has not had a marked change in smoking or tobacco/nicotine use from 30&#xD;
             days before Screening.&#xD;
&#xD;
          9. Must reside in a stable residence for at least 8 weeks before the Screening Visit&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. At risk of suicide (e.g., per Columbia Suicide Severity Rating Scale [C-SSRS]) or have&#xD;
             made a suicide attempt in the 6 months before Screening&#xD;
&#xD;
          2. Has a known sensitivity to sulfur-containing drugs or sulfates in food&#xD;
&#xD;
          3. Taking any medication known to influence coagulation, such as acetylsalicylic acid&#xD;
             (aspirin), and including prescription, herbal remedies, vitamin supplements and&#xD;
             over-the-counter products&#xD;
&#xD;
          4. Has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary,&#xD;
             hepatic, renal, metabolic, gastrointestinal or endocrine disease or other abnormality&#xD;
             (other than the disease being studied), which may impact the ability of the subject to&#xD;
             participate or potentially confound the study results&#xD;
&#xD;
          5. Has a positive urine drug result for drugs of abuse (i.e., illicit, illegal or without&#xD;
             valid prescription or medical need) at Screening or Admission&#xD;
&#xD;
          6. Has donated or lost 450 mL or more of his or her blood volume (including&#xD;
             plasmapheresis), or had a transfusion of any blood product within 45 days before Day 1&#xD;
&#xD;
          7. Has an abnormal (clinically significant) electrocardiogram (ECG) at Screening or unit&#xD;
             admission day&#xD;
&#xD;
          8. Has a blood pressure and pulse rate outside the protocol defined ranges&#xD;
&#xD;
          9. Has a QT interval or PR outside of the protocol defined ranges&#xD;
&#xD;
         10. Has abnormal laboratory values that suggest a clinically significant underlying&#xD;
             disease&#xD;
&#xD;
         11. Has a history of a primary DSM-IV axis I diagnosis other than schizophrenia&#xD;
&#xD;
         12. Has a medical condition other than schizophrenia (e.g., dementia, antisocial&#xD;
             personality, borderline personality disorders) that can cause cognitive impairment or&#xD;
             interfere with the performance or completion of study-defined procedures&#xD;
&#xD;
         13. Has been taking medication for a medical condition for less than 2 months even if at a&#xD;
             stable dose or regimen&#xD;
&#xD;
         14. Currently taking lithium or any psychotropic medication that cannot be discontinued&#xD;
             for safety reasons&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Glendale Adventist Medical Center</name>
      <address>
        <city>Glendale</city>
        <state>California</state>
        <zip>91206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2015</verification_date>
  <study_first_submitted>July 22, 2014</study_first_submitted>
  <study_first_submitted_qc>July 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 31, 2014</study_first_posted>
  <disposition_first_submitted>October 12, 2016</disposition_first_submitted>
  <disposition_first_submitted_qc>October 12, 2016</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">October 13, 2016</disposition_first_posted>
  <last_update_submitted>October 12, 2016</last_update_submitted>
  <last_update_submitted_qc>October 12, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 13, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Schizophrenia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Schizophrenia</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</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/NCT02205099
org study id: SKL15508C003
nct id: NCT02205099
lead sponsor: 
has dmc: No
This is a single-site, randomized, double-blind, placebo-controlled, multiple dose, flexible
      dosage range, PK and PD study of SKL15508 as monotherapy in subjects with stable
      schizophrenia.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Number and percent of subjects experiencing an adverse event.
time frame: 10 days
measure: Change from baseline in event-related potentials (ERP) following multiple oral doses of SKL15508.
time frame: During the course of 10 days
measure: Change from baseline in clinical laboratory assessments.
time frame: 10 days
measure: Change from baseline in vital signs.
time frame: 10 days
arm group label: SKL15508 High Dose
arm group type: Experimental
description: SKL15508 High Dose
arm group label: SKL15508 Medium Dose
arm group type: Experimental
description: SKL15508 Medium Dose
arm group label: SKL15508 Low Dose
arm group type: Experimental
description: SKL15508 Low Dose
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo
intervention type: Drug
intervention name: SKL15508
arm group label: SKL15508 High Dose
arm group label: SKL15508 Low Dose
arm group label: SKL15508 Medium Dose
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Schizophrenia