<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/NCT02970019</url>
  </required_header>
  <id_info>
    <org_study_id>CLR_16_27</org_study_id>
    <nct_id>NCT02970019</nct_id>
  </id_info>
  <brief_title>Safety and Tolerability Study of K0706 in Subjects With Parkinson's Disease</brief_title>
  <official_title>A Double-blind, Placebo-controlled Study to Determine Safety, Tolerability, Pharmacokinetic of K0706.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sun Pharma Advanced Research Company Limited</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sun Pharma Advanced Research Company Limited</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a safety, tolerability and pharmacokinetic study in subjects with Parkinson's disease&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 30, 2017</start_date>
  <completion_date type="Actual">May 28, 2019</completion_date>
  <primary_completion_date type="Actual">May 28, 2019</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adverse events</measure>
    <time_frame>4 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Peak plasma concentration</measure>
    <time_frame>4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the plasma concentration versus time curve</measure>
    <time_frame>4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time of observed peak plasma concentration</measure>
    <time_frame>4 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Parkinson Disease</condition>
  <arm_group>
    <arm_group_label>K0706</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>K0706 will be administered once a day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Placebo will be administered once a day</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>K0706</intervention_name>
    <description>Once a day administration after fast</description>
    <arm_group_label>K0706</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Once a day administration after fast</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Willing and able to give written, and dated, informed consent (or legally acceptable&#xD;
             representative/impartial witness when applicable) and is available for the entire&#xD;
             study&#xD;
&#xD;
          2. Willing and able to comply with the scheduled visits, treatment plan, laboratory&#xD;
             testing, study procedures, and restrictions (in the Investigator's opinion), and be&#xD;
             accessible for follow-up&#xD;
&#xD;
          3. Male or female aged 18 to 65 years (both inclusive)&#xD;
&#xD;
          4. Diagnosed with Parkinson's disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Clinical diagnosis of genetic form of Parkinson's disease, or drug-induced&#xD;
             parkinsonism&#xD;
&#xD;
          2. Diagnosis of Parkinson's disease Dementia (probable, possible)&#xD;
&#xD;
          3. Presence of severe dyskinesias&#xD;
&#xD;
          4. History of brain surgery for Parkinson's disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>SPARC Site 03</name>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <zip>90806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SPARC Site 05</name>
      <address>
        <city>Panorama City</city>
        <state>California</state>
        <zip>91402</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SPARC Site 01</name>
      <address>
        <city>DeLand</city>
        <state>Florida</state>
        <zip>32720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SPARC Site 02</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SPARC Site 04</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>November 18, 2016</study_first_submitted>
  <study_first_submitted_qc>November 18, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2016</study_first_posted>
  <last_update_submitted>March 29, 2020</last_update_submitted>
  <last_update_submitted_qc>March 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 31, 2020</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>Parkinson Disease</mesh_term>
  </condition_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/NCT02970019
org study id: CLR_16_27
nct id: NCT02970019
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This is a safety, tolerability and pharmacokinetic study in subjects with Parkinson's disease
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Adverse events
time frame: 4 weeks
measure: Peak plasma concentration
time frame: 4 weeks
measure: Area under the plasma concentration versus time curve
time frame: 4 weeks
measure: Time of observed peak plasma concentration
time frame: 4 weeks
arm group label: K0706
arm group type: Experimental
description: K0706 will be administered once a day
arm group label: Placebo
arm group type: Experimental
description: Placebo will be administered once a day
intervention type: Drug
intervention name: K0706
description: Once a day administration after fast
arm group label: K0706
intervention type: Drug
intervention name: Placebo
description: Once a day administration after fast
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Parkinson Disease