<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/NCT03787004</url>
  </required_header>
  <id_info>
    <org_study_id>CNTX-6970-HV-102</org_study_id>
    <nct_id>NCT03787004</nct_id>
  </id_info>
  <brief_title>A Placebo-Controlled, Two-Part Study, Oral Dose to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of CNTX-6970 in Healthy Subjects</brief_title>
  <official_title>A Placebo-Controlled, Two-Part Study With Single Dose and Multiple Ascending Oral Dose to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of CNTX-6970 in Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centrexion Therapeutics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centrexion Therapeutics</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>
      A Phase 1, placebo-controlled, two part study with either single dose or multiple increasing&#xD;
      oral dose to evaluate the safety, pharmacokinetics, and pharmacodynamics of CNTX-6970 in&#xD;
      healthy subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 14, 2017</start_date>
  <completion_date type="Actual">September 26, 2018</completion_date>
  <primary_completion_date type="Actual">August 19, 2018</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>None (Open Label)</masking>
    <masking_description>Part 1: Open Label Part 2: Double-Blind</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>CNTX-6970 Pharmacokinetics - fasted state or high-fat standardized meal</measure>
    <time_frame>Up to Day 3</time_frame>
    <description>Food effects on pharmacokinetics of CTNX-6790 for Part 1 participants</description>
  </primary_outcome>
  <primary_outcome>
    <measure>CNTX-6970 Pharmacokinetics - AUC0-t</measure>
    <time_frame>Up to Day 13</time_frame>
    <description>Systemic exposure to CNTX-6970 measured by AUC0-t</description>
  </primary_outcome>
  <primary_outcome>
    <measure>CNTX-6970 Pharmacokinetics - AUC0-inf</measure>
    <time_frame>Up to Day 13</time_frame>
    <description>Systemic exposure to CNTX-6970 measured by AUC0-inf</description>
  </primary_outcome>
  <primary_outcome>
    <measure>CNTX-6970 Pharmacokinetics - Cmax</measure>
    <time_frame>Up to Day 13</time_frame>
    <description>Systemic exposure to CNTX-6970 measured by Cmax</description>
  </primary_outcome>
  <primary_outcome>
    <measure>CNTX-6970 Pharmacokinetics - tmax</measure>
    <time_frame>Up to Day 13</time_frame>
    <description>Systemic exposure to CNTX-6970 measured by tmax</description>
  </primary_outcome>
  <primary_outcome>
    <measure>CNTX-6970 Pharmacokinetics - t1/2</measure>
    <time_frame>Up to Day 13</time_frame>
    <description>Systemic exposure to CNTX-6970 measured by t1/2</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of treatment-emergent adverse events (TEAEs) (safety and tolerability)</measure>
    <time_frame>Up to Day 13</time_frame>
    <description>Number of participants with TEAEs, which includes laboratory test variables</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CNTX-6970 Pharmacodynamics - Emax</measure>
    <time_frame>Up to Day 13</time_frame>
    <description>Pharmacodynamic effect on MCP-1 and RANTES measured by Emax</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CNTX-6970 Pharmacodynamics - PD tmax</measure>
    <time_frame>Up to Day 13</time_frame>
    <description>Time to maximum pharmacodynamic effect on MCP-1 and RANTES measured by tmax</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">62</enrollment>
  <condition>Chronic Pain</condition>
  <condition>Nociceptive Pain</condition>
  <arm_group>
    <arm_group_label>Part 1 Cohort 1 (Single Dose)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single 100 mg oral dose of CNTX-6970 (film-coated tablet or enteric-coated tablet)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 1 Cohort 2 (Single Dose)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single 100 mg oral dose of CNTX-6970 film-coated tablet</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 2 (Multiple Ascending Dose)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>100 mg, 300 mg, and 600 mg CNTX-6970 oral tablet</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 2 Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo oral tablet</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CNTX-6970</intervention_name>
    <description>Oral dose CNTX-6970</description>
    <arm_group_label>Part 1 Cohort 1 (Single Dose)</arm_group_label>
    <arm_group_label>Part 1 Cohort 2 (Single Dose)</arm_group_label>
    <arm_group_label>Part 2 (Multiple Ascending Dose)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Oral dose placebo</description>
    <arm_group_label>Part 2 Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          -  Is in good general health as determined by the Investigator's review&#xD;
&#xD;
          -  Has a body mass index (BMI) between 18 and 35kg/m^2, inclusive&#xD;
&#xD;
          -  For females, is not currently pregnant or breastfeeding and is either of&#xD;
             non-childbearing potential or willing to use an adequate method of birth control&#xD;
&#xD;
          -  For males, must agree to use barrier contraception and not to donate sperm&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          -  Has a history of cardiac disease, including congestive heart failure, angina, or any&#xD;
             arrhythmia&#xD;
&#xD;
          -  Has diabetes mellitus, acromegaly, clinically active thyroid disease, or other active&#xD;
             endocrinopathy&#xD;
&#xD;
          -  Has any history or currently active type of cancer except excised or cured basal cell&#xD;
             carcinoma&#xD;
&#xD;
          -  Has a gastrointestinal disorder that could interfere with the absorption of orally&#xD;
             administered drugs&#xD;
&#xD;
          -  Has asthma or other severe respiratory disease (e.g., chronic obstructive pulmonary&#xD;
             disease) requiring daily prescription medicine&#xD;
&#xD;
          -  Currently has kidney, neurologic, metabolic, or liver disease, or other organ system&#xD;
             disease&#xD;
&#xD;
          -  Has a history, current evidence, or is being treated for depression, suicidal&#xD;
             ideation, suicide attempt, or any other current psychiatric condition requiring active&#xD;
             treatment&#xD;
&#xD;
          -  Has an immunological disorder such as, but not limited to, human immunodeficiency&#xD;
             virus (HIV), acquired, or congenital immune deficiency syndrome; autoimmune diseases,&#xD;
             such as, but not limited to, rheumatoid arthritis, systemic lupus erythematosus,&#xD;
             seronegative spondyloarthropathies or vasculitis, or any infection&#xD;
&#xD;
          -  Has positive screening test for hepatitis B virus (HBV) or hepatitis C virus (HCV);&#xD;
&#xD;
          -  Is pregnant, lactating, or planning a pregnancy during the study&#xD;
&#xD;
          -  Has used any prescribed medication within 30 days prior to the first admission or has&#xD;
             plans to use any prescribed medication during the study (with the exception of&#xD;
             hormonal contraceptives)&#xD;
&#xD;
          -  Has used within 14 days prior to the first admission or has plans to use during the&#xD;
             study any over-the-counter medicinal products, including herbal and dietary&#xD;
             supplements (except for occasional use of acetaminophen or NSAIDs, such as ibuprofen&#xD;
             or naproxen; calcium; or Vitamin D)&#xD;
&#xD;
          -  Use of any of the following:&#xD;
&#xD;
               -  Human growth hormone, octreotide, anti-diabetic medication, or thyroid&#xD;
                  suppressors or supplements&#xD;
&#xD;
               -  Immunosuppressive drugs within 30 days of study start, or 5 half-lives of the&#xD;
                  drug (whichever is longer), or plans to use during the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Randall M. Stevens, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Centrexion Therapeutics</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medpace Clinical Pharmacology Unit</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45227</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 21, 2018</study_first_submitted>
  <study_first_submitted_qc>December 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 26, 2018</study_first_posted>
  <last_update_submitted>December 21, 2018</last_update_submitted>
  <last_update_submitted_qc>December 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Chronic Pain</keyword>
  <keyword>Nociceptive Pain</keyword>
  <keyword>Mixed Pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Pain</mesh_term>
    <mesh_term>Nociceptive Pain</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/NCT03787004
org study id: CNTX-6970-HV-102
nct id: NCT03787004
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
A Phase 1, placebo-controlled, two part study with either single dose or multiple increasing
      oral dose to evaluate the safety, pharmacokinetics, and pharmacodynamics of CNTX-6970 in
      healthy subjects.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
masking description: Part 1: Open Label Part 2: Double-Blind
measure: CNTX-6970 Pharmacokinetics - fasted state or high-fat standardized meal
time frame: Up to Day 3
description: Food effects on pharmacokinetics of CTNX-6790 for Part 1 participants
measure: CNTX-6970 Pharmacokinetics - AUC0-t
time frame: Up to Day 13
description: Systemic exposure to CNTX-6970 measured by AUC0-t
measure: CNTX-6970 Pharmacokinetics - AUC0-inf
time frame: Up to Day 13
description: Systemic exposure to CNTX-6970 measured by AUC0-inf
measure: CNTX-6970 Pharmacokinetics - Cmax
time frame: Up to Day 13
description: Systemic exposure to CNTX-6970 measured by Cmax
measure: CNTX-6970 Pharmacokinetics - tmax
time frame: Up to Day 13
description: Systemic exposure to CNTX-6970 measured by tmax
measure: CNTX-6970 Pharmacokinetics - t1/2
time frame: Up to Day 13
description: Systemic exposure to CNTX-6970 measured by t1/2
measure: Incidence of treatment-emergent adverse events (TEAEs) (safety and tolerability)
time frame: Up to Day 13
description: Number of participants with TEAEs, which includes laboratory test variables
measure: CNTX-6970 Pharmacodynamics - Emax
time frame: Up to Day 13
description: Pharmacodynamic effect on MCP-1 and RANTES measured by Emax
measure: CNTX-6970 Pharmacodynamics - PD tmax
time frame: Up to Day 13
description: Time to maximum pharmacodynamic effect on MCP-1 and RANTES measured by tmax
arm group label: Part 1 Cohort 1 (Single Dose)
arm group type: Experimental
description: Single 100 mg oral dose of CNTX-6970 (film-coated tablet or enteric-coated tablet)
arm group label: Part 1 Cohort 2 (Single Dose)
arm group type: Experimental
description: Single 100 mg oral dose of CNTX-6970 film-coated tablet
arm group label: Part 2 (Multiple Ascending Dose)
arm group type: Experimental
description: 100 mg, 300 mg, and 600 mg CNTX-6970 oral tablet
arm group label: Part 2 Placebo
arm group type: Placebo Comparator
description: Placebo oral tablet
intervention type: Drug
intervention name: CNTX-6970
description: Oral dose CNTX-6970
arm group label: Part 1 Cohort 1 (Single Dose)
arm group label: Part 1 Cohort 2 (Single Dose)
arm group label: Part 2 (Multiple Ascending Dose)
intervention type: Other
intervention name: Placebo
description: Oral dose placebo
arm group label: Part 2 Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 64 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Randall M. Stevens, MD
role: Study Chair
affiliation: Centrexion Therapeutics
facility: 
country: United States
responsible party type: Sponsor
mesh term: Chronic Pain
mesh term: Nociceptive Pain