<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/NCT03830463</url>
  </required_header>
  <id_info>
    <org_study_id>CP692.1002</org_study_id>
    <nct_id>NCT03830463</nct_id>
  </id_info>
  <brief_title>Study to Assess the Safety and Pharmacokinetic (PK) of CTP-692 in Healthy Volunteers</brief_title>
  <official_title>A Placebo-Controlled, Double-Blind, Single Ascending Dose Study to Evaluate the Safety and Pharmacokinetic Profile of CTP-692 in Fed and Fasted Conditions in Healthy Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Concert Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Concert Pharmaceuticals</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will assess the safety and pharmacokinetic (PK) profile of single ascending doses&#xD;
      of CTP-692 in healthy volunteers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 24, 2019</start_date>
  <completion_date type="Actual">March 28, 2019</completion_date>
  <primary_completion_date type="Actual">March 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>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants with Adverse Events as a Measure of Safety</measure>
    <time_frame>48 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Measurement of CTP-692 exposure in plasma under fasted conditions</measure>
    <time_frame>48 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Measurement of CTP-692 exposure in plasma under fed conditions</measure>
    <time_frame>48 hours</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>CTP-692</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CTP-692</intervention_name>
    <description>Single oral dose</description>
    <arm_group_label>CTP-692</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Single oral dose</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy adult males and females between 18 and 55 years of age, inclusive&#xD;
&#xD;
          -  Body weight ≥ 55 kg and BMI within the range of 18 to 32 kg/m2, inclusive&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Screening laboratory measurements outside the normal range associated with potential&#xD;
             risk for the treatment under investigation at screening and/or prior to the first dose&#xD;
             of study drug&#xD;
&#xD;
          -  Positive blood screen for human immunodeficiency virus (HIV antibody), hepatitis B&#xD;
             virus surface antigen or hepatitis C virus antibody&#xD;
&#xD;
          -  History of clinically significant central nervous system (e.g., seizures), cardiac,&#xD;
             pulmonary, metabolic, renal, hepatic or gastrointestinal (GI) conditions&#xD;
&#xD;
          -  Positive drug or alcohol test at screening or prior to the first dose of study drug&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Emily McIntyre</last_name>
    <role>Study Director</role>
    <affiliation>Concert Pharmaceuticals, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Collaborative Neuroscience Network, LLC</name>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <zip>90806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>February 2, 2019</study_first_submitted>
  <study_first_submitted_qc>February 2, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 5, 2019</study_first_posted>
  <last_update_submitted>June 12, 2019</last_update_submitted>
  <last_update_submitted_qc>June 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 13, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03830463
org study id: CP692.1002
nct id: NCT03830463
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
This study will assess the safety and pharmacokinetic (PK) profile of single ascending doses
      of CTP-692 in healthy volunteers.
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Number of Participants with Adverse Events as a Measure of Safety
time frame: 48 hours
measure: Measurement of CTP-692 exposure in plasma under fasted conditions
time frame: 48 hours
measure: Measurement of CTP-692 exposure in plasma under fed conditions
time frame: 48 hours
arm group label: CTP-692
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: CTP-692
description: Single oral dose
arm group label: CTP-692
intervention type: Drug
intervention name: Placebo
description: Single oral dose
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Emily McIntyre
role: Study Director
affiliation: Concert Pharmaceuticals, Inc.
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No