<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/NCT02215499</url>
  </required_header>
  <id_info>
    <org_study_id>CP386.1001</org_study_id>
    <nct_id>NCT02215499</nct_id>
  </id_info>
  <brief_title>A Phase 1, Single Dose Study of JZP-386 to Evaluate Safety, Pharmacokinetics and Pharmacodynamics</brief_title>
  <official_title>A Double-Blind, Phase 1, Single-Center, Single-Ascending Dose Study of JZP-386 Compared to Xyrem® vs. Placebo to Evaluate the Safety and Pharmacokinetics</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Concert Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Concert Pharmaceuticals</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is being conducted to evaluate the safety, tolerability, blood distribution and&#xD;
      effectiveness single ascending doses of JZP-386 compared to doses of Xyrem® and placebo.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Phase 1, single center, single-ascending dose, sequential, randomized, and&#xD;
      crossover study.&#xD;
&#xD;
      Following a Screening period of up to 21 days, eligible subjects will be randomized different&#xD;
      dosing sequences, with approximately 4 subjects allocated to each dosing sequence. The total&#xD;
      in-clinic duration for each subject will be 24 days (including the admission day prior to the&#xD;
      first dosing period).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">November 2014</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>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>safety</measure>
    <time_frame>3 days</time_frame>
    <description>Evaluate and compare the safety including adverse event monitoring (number and type of events), vital signs, pulse oximetry of single ascending doses of JZP-386 to Xyrem (sodium oxybate) and placebo in healthy subjects.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>pharmacokinetics</measure>
    <time_frame>12 hours</time_frame>
    <description>Evaluate the pharmacokinetics (AUC, Cmax) of of JZP-386 compared to Xyrem in healthy subjects.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Narcolepsy, Excessive Daytime Sleepiness</condition>
  <arm_group>
    <arm_group_label>Xyrem®</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Oral suspension</description>
  </arm_group>
  <arm_group>
    <arm_group_label>JZP-386</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Oral suspension</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Oral suspension</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>JZP-386</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>Xyrem®</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sodium Oxybate</intervention_name>
    <arm_group_label>Xyrem®</arm_group_label>
    <other_name>Xyrem®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>JZP-386</intervention_name>
    <arm_group_label>JZP-386</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male and female volunteer subjects, 18 to 50 years of age, inclusive.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Clinically significant history of unstable medical abnormality. Inability to cooperate with&#xD;
        study procedures. Female subjects with a positive pregnancy test result, nursing or&#xD;
        lactating. Participation in any other investigational drug trial within 90 days prior to&#xD;
        screening. A history of prescription drug abuse, or illicit drug or known drug dependence&#xD;
        within last 5 years prior to screening. Use of any prescription medication within 14 days&#xD;
        prior to dosing. A history of alcohol abuse or dependence.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>LuAnn Sabounjian</last_name>
    <role>Study Director</role>
    <affiliation>Concert Pharmaceuticals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Quotient Clinical Ltd.</name>
      <address>
        <city>Ruddington</city>
        <state>Nottingham</state>
        <zip>NG11 6JS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>August 8, 2014</study_first_submitted>
  <study_first_submitted_qc>August 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2014</study_first_posted>
  <last_update_submitted>May 28, 2015</last_update_submitted>
  <last_update_submitted_qc>May 28, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 29, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>JZP-386, Xyrem, sodium oxybate</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Narcolepsy</mesh_term>
    <mesh_term>Disorders of Excessive Somnolence</mesh_term>
    <mesh_term>Sleepiness</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sodium Oxybate</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/NCT02215499
org study id: CP386.1001
nct id: NCT02215499
lead sponsor: 
has dmc: No
This study is being conducted to evaluate the safety, tolerability, blood distribution and
      effectiveness single ascending doses of JZP-386 compared to doses of Xyrem® and placebo.
This is a Phase 1, single center, single-ascending dose, sequential, randomized, and
      crossover study.

      Following a Screening period of up to 21 days, eligible subjects will be randomized different
      dosing sequences, with approximately 4 subjects allocated to each dosing sequence. The total
      in-clinic duration for each subject will be 24 days (including the admission day prior to the
      first dosing period).
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: safety
time frame: 3 days
description: Evaluate and compare the safety including adverse event monitoring (number and type of events), vital signs, pulse oximetry of single ascending doses of JZP-386 to Xyrem (sodium oxybate) and placebo in healthy subjects.
measure: pharmacokinetics
time frame: 12 hours
description: Evaluate the pharmacokinetics (AUC, Cmax) of of JZP-386 compared to Xyrem in healthy subjects.
arm group label: Xyrem®
arm group type: Active Comparator
description: Oral suspension
arm group label: JZP-386
arm group type: Experimental
description: Oral suspension
arm group label: Placebo
arm group type: Placebo Comparator
description: Oral suspension
intervention type: Drug
intervention name: Placebo
arm group label: JZP-386
arm group label: Placebo
arm group label: Xyrem®
intervention type: Drug
intervention name: Sodium Oxybate
arm group label: Xyrem®
other name: Xyrem®
intervention type: Drug
intervention name: JZP-386
arm group label: JZP-386
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: LuAnn Sabounjian
role: Study Director
affiliation: Concert Pharmaceuticals
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Narcolepsy
mesh term: Disorders of Excessive Somnolence
mesh term: Sleepiness
mesh term: Sodium Oxybate