<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/NCT03033329</url>
  </required_header>
  <id_info>
    <org_study_id>MRX4-002</org_study_id>
    <nct_id>NCT03033329</nct_id>
  </id_info>
  <brief_title>Single Dose Escalation and Multiple Dose Escalation Trial of an Intravenous Formulation of MRX-4</brief_title>
  <official_title>A Randomized, Double-Blind, Placebo Controlled Three-Part Study of the Safety, Tolerability, and Pharmacokinetics of MRX 4 Administered Intravenously to Healthy Volunteers in Single Ascending and Multiple Ascending Dose Cohorts, and Bioavailability of Oral MRX-4 Versus Intravenous Administration</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>MicuRx</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Worldwide Clinical Trials</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>MicuRx</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A Phase 1 study of the safety, tolerability, and pharmacokinetics of a new oxazolidinone&#xD;
      antibiotic. In Part 1 cohorts of healthy adults will participate in a single dose escalation&#xD;
      study of increasing intravenous doses of MRX-4. In Part 2 cohorts of healthy adults will&#xD;
      participate in a multiple dose escalation study of increasing intravenous doses of MRX-4&#xD;
      given twice daily for ten days. Part 3 is a crossover study of oral MRX-4 versus a comparable&#xD;
      intravenous dose of MRX-4 to determine bioavailability.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2016</start_date>
  <completion_date type="Actual">March 2018</completion_date>
  <primary_completion_date type="Actual">March 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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety of single and multiple ascending doses of MRX-4</measure>
    <time_frame>Screening through end of study visit on Day 7 (Part 1), Day 17 (Part II) and Day 15 (Part III)</time_frame>
    <description>Summary statistics of the number of subjects with changes in vital signs, physical examinations, clinical lab data, ecg parameters, and adverse events</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Plasma concentration time data for MRX-4 and its metabolites</measure>
    <time_frame>Pre-dose through 72 hours post dose</time_frame>
    <description>Individual and mean plasma concentration time data for MRX-4 and its metabolites</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bioavailability of MRX-I and other MRX-4 metabolites</measure>
    <time_frame>Pre-dose through 72 hours post dose</time_frame>
    <description>Levels of MRX-4 and its metabolites in blood</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of the pharmacokinetics of oral versus intravenous MRX-4 and its metabolites</measure>
    <time_frame>Pre-dose through 72 hours post dose</time_frame>
    <description>Levels of MRX-4 and its metabolites in blood</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Elimination of MRX-4 and its metabolites in the urine following single dose adminstration</measure>
    <time_frame>Pre-dose through 72 hours post dose</time_frame>
    <description>Levels of MRX-4 and its metabolites in urine</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Safety</condition>
  <arm_group>
    <arm_group_label>Single intravenous doses of MRX-4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single escalating intravenous doses of MRX-4 from 150 mg to 1800 mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Single intravenous doses of placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Single intravenous doses of placebo to match MRX-4</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Multiple intravenous doses of MRX-4</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Twice daily escalating intravenous doses of MRX-4 for 10 days: 600 mg, 900 mg, 1200 mg, and 1500 mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Multiple intravenous doses of placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Twice daily intravenous doses of placebo to match MRX-4 for 10 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Single dose of intravenous and oral MRX-4</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Crossover of single dose of intravenous and oral MRX-4</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Single intravenous doses of MRX-4</intervention_name>
    <description>Intravenous single escalating doses of MRX-4</description>
    <arm_group_label>Single intravenous doses of MRX-4</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Single intravenous doses of placebo</intervention_name>
    <description>Intravenous single doses of placebo to match MRX-4</description>
    <arm_group_label>Single intravenous doses of placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Multiple intravenous doses of MRX-4</intervention_name>
    <description>Multiple ascending doses of MRX-4 given intravenously twice daily for 10 days</description>
    <arm_group_label>Multiple intravenous doses of MRX-4</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Multiple intravenous doses of placebo</intervention_name>
    <description>Multiple doses of placebo to match MRX-4 given intravenously twice daily for 10 days</description>
    <arm_group_label>Multiple intravenous doses of placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Single dose of intravenous and oral MRX-4</intervention_name>
    <description>Crossover single dose of intravenous and oral MRX-4 given on Day 1 and Day 4</description>
    <arm_group_label>Single dose of intravenous and oral MRX-4</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy subjects&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Underlying hepatic, renal, metabolic, hematologic, cardiovascular, or immunologic&#xD;
             disorder&#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>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 16, 2017</study_first_submitted>
  <study_first_submitted_qc>January 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 26, 2017</study_first_posted>
  <last_update_submitted>March 20, 2018</last_update_submitted>
  <last_update_submitted_qc>March 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 22, 2018</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/NCT03033329
org study id: MRX4-002
nct id: NCT03033329
lead sponsor: 
collaborator: 
has dmc: Yes
A Phase 1 study of the safety, tolerability, and pharmacokinetics of a new oxazolidinone
      antibiotic. In Part 1 cohorts of healthy adults will participate in a single dose escalation
      study of increasing intravenous doses of MRX-4. In Part 2 cohorts of healthy adults will
      participate in a multiple dose escalation study of increasing intravenous doses of MRX-4
      given twice daily for ten days. Part 3 is a crossover study of oral MRX-4 versus a comparable
      intravenous dose of MRX-4 to determine bioavailability.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Safety of single and multiple ascending doses of MRX-4
time frame: Screening through end of study visit on Day 7 (Part 1), Day 17 (Part II) and Day 15 (Part III)
description: Summary statistics of the number of subjects with changes in vital signs, physical examinations, clinical lab data, ecg parameters, and adverse events
measure: Plasma concentration time data for MRX-4 and its metabolites
time frame: Pre-dose through 72 hours post dose
description: Individual and mean plasma concentration time data for MRX-4 and its metabolites
measure: Bioavailability of MRX-I and other MRX-4 metabolites
time frame: Pre-dose through 72 hours post dose
description: Levels of MRX-4 and its metabolites in blood
measure: Comparison of the pharmacokinetics of oral versus intravenous MRX-4 and its metabolites
time frame: Pre-dose through 72 hours post dose
description: Levels of MRX-4 and its metabolites in blood
measure: Elimination of MRX-4 and its metabolites in the urine following single dose adminstration
time frame: Pre-dose through 72 hours post dose
description: Levels of MRX-4 and its metabolites in urine
arm group label: Single intravenous doses of MRX-4
arm group type: Experimental
description: Single escalating intravenous doses of MRX-4 from 150 mg to 1800 mg
arm group label: Single intravenous doses of placebo
arm group type: Placebo Comparator
description: Single intravenous doses of placebo to match MRX-4
arm group label: Multiple intravenous doses of MRX-4
arm group type: Active Comparator
description: Twice daily escalating intravenous doses of MRX-4 for 10 days: 600 mg, 900 mg, 1200 mg, and 1500 mg
arm group label: Multiple intravenous doses of placebo
arm group type: Placebo Comparator
description: Twice daily intravenous doses of placebo to match MRX-4 for 10 days
arm group label: Single dose of intravenous and oral MRX-4
arm group type: Active Comparator
description: Crossover of single dose of intravenous and oral MRX-4
intervention type: Drug
intervention name: Single intravenous doses of MRX-4
description: Intravenous single escalating doses of MRX-4
arm group label: Single intravenous doses of MRX-4
intervention type: Drug
intervention name: Single intravenous doses of placebo
description: Intravenous single doses of placebo to match MRX-4
arm group label: Single intravenous doses of placebo
intervention type: Drug
intervention name: Multiple intravenous doses of MRX-4
description: Multiple ascending doses of MRX-4 given intravenously twice daily for 10 days
arm group label: Multiple intravenous doses of MRX-4
intervention type: Drug
intervention name: Multiple intravenous doses of placebo
description: Multiple doses of placebo to match MRX-4 given intravenously twice daily for 10 days
arm group label: Multiple intravenous doses of placebo
intervention type: Drug
intervention name: Single dose of intravenous and oral MRX-4
description: Crossover single dose of intravenous and oral MRX-4 given on Day 1 and Day 4
arm group label: Single dose of intravenous and oral MRX-4
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
sharing ipd: No