<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/NCT03033342</url>
  </required_header>
  <id_info>
    <org_study_id>MRX4-001</org_study_id>
    <nct_id>NCT03033342</nct_id>
  </id_info>
  <brief_title>Single Dose Escalation and Multiple Dose Escalation Trial of an Oral Formulation of MRX-4</brief_title>
  <official_title>A Randomized, Double-Blind, Placebo Controlled Three-Part Phase 1 Study of the Safety, Tolerability, Pharmacokinetics, and Food Effect of MRX 4 Administered Orally to Healthy Volunteers in Single Ascending and Multiple Ascending Dose Cohorts, and to Evaluate Drug Interactions With Omeprazole</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 one study of the safety, tolerability, and pharmacokinetics of a new oxazolidinone&#xD;
      antibiotic. Cohorts of healthy adults (female and male) will participate in:&#xD;
&#xD;
      single dose escalation study of increasing doses of MRX-4 given by mouth others will&#xD;
      participate in multiple dose escalation cohorts of MRX-4 given twice daily by mouth.&#xD;
&#xD;
      other cohorts of subjects will participate in the study to evaluate the impact of concomitant&#xD;
      food or Omeprazole on safety, tolerability and pharmacokinetics of MRX-4&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2, 2016</start_date>
  <completion_date type="Actual">February 1, 2017</completion_date>
  <primary_completion_date type="Actual">February 1, 2017</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>Other</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 14 (Part III)</time_frame>
    <description>Summary of number of subjects with changes in vital signs, physical examinations, clinical lab data, ECG parameters and adverse events</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Summary of concentration time data for MRX-4 and its metabolites</measure>
    <time_frame>Pre-dose through 72 hours post dose</time_frame>
    <description>Concentration time data for MRX-4 and its metabolites in blood and urine</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Summary of the plasma concentration teim data for MRX-4 under fed or fasted conditions</measure>
    <time_frame>Pre-dose through 72 hours post dose</time_frame>
    <description>Concentration time data for MRX-4 and its metabolites in blood and urine under fed and fasted conditions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of MRX-4 co-administered with omeprazole</measure>
    <time_frame>Screening through end of study on Day 14</time_frame>
    <description>Summary of the number of subjects with changes in vital signs, physical examinations, clinical lab data, ecg parameters and adverse events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Summary of the plasma concentration time data for MRX-4 co-administered with omeprazole</measure>
    <time_frame>Pre-dose through 72 hours post dose</time_frame>
    <description>Concentation time data for MRX-4 and its metabolites in blood and urine with and without omeprazole</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">122</enrollment>
  <condition>Safety</condition>
  <arm_group>
    <arm_group_label>Oral single doses of MRX-4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single escalating oral doses of MRX-4 from 250 mg to 3000 mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Oral multiple doses of MRX-4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Twice daily escalating oral doses of MRX-4 for 10 days: 500 mg, 750 mg, 1000 mg, and 1500 mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MRX-4 co-administered with omeprazole</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Impact of concomitant food or omeprazole on the pharmacokinetics of oral MRX-4.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Oral single doses of placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Single oral doses of placebo to match MRX-4</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Oral multiple doses of placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Multiple oral doses of placebo given twice daily for 10 days to match MRX-4</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo co-administered with omeprazole</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Oral placebo given on Day 1, Day 7 to match MRX-4 dosing with omeprazole</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oral single doses of MRX-4</intervention_name>
    <description>Oral single escalating doses of MRX-4</description>
    <arm_group_label>Oral single doses of MRX-4</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oral multiple doses of MRX-4</intervention_name>
    <description>Multiple ascending doses of MRX-4 given twice daily for 10 days</description>
    <arm_group_label>Oral multiple doses of MRX-4</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MRX-4 co-administered with omeprazole</intervention_name>
    <description>MRX-4 given orally on Day 1 and Day 7, co-administered with omeprazole on Day 3 through Day 7</description>
    <arm_group_label>MRX-4 co-administered with omeprazole</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oral single doses of placebo</intervention_name>
    <description>Single doses of placebo to match MRX-4</description>
    <arm_group_label>Oral single doses of placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oral multiple doses of placebo</intervention_name>
    <description>Oral placebo given twice daily for 10 days to match the oral MRX-4</description>
    <arm_group_label>Oral multiple doses of placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo co-administered with omeprazole</intervention_name>
    <description>Placebo given orally on Day 1 and Day 7, co-administered with omeprazole on Day 3 through Day 7</description>
    <arm_group_label>Placebo co-administered with omeprazole</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>September 2017</verification_date>
  <study_first_submitted>December 19, 2016</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>September 3, 2017</last_update_submitted>
  <last_update_submitted_qc>September 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Phase 1</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Omeprazole</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>The study results will be published in the future</ipd_description>
  </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/NCT03033342
org study id: MRX4-001
nct id: NCT03033342
lead sponsor: 
collaborator: 
has dmc: Yes
A phase one study of the safety, tolerability, and pharmacokinetics of a new oxazolidinone
      antibiotic. Cohorts of healthy adults (female and male) will participate in:

      single dose escalation study of increasing doses of MRX-4 given by mouth others will
      participate in multiple dose escalation cohorts of MRX-4 given twice daily by mouth.

      other cohorts of subjects will participate in the study to evaluate the impact of concomitant
      food or Omeprazole on safety, tolerability and pharmacokinetics of MRX-4
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
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 14 (Part III)
description: Summary of number of subjects with changes in vital signs, physical examinations, clinical lab data, ECG parameters and adverse events
measure: Summary of concentration time data for MRX-4 and its metabolites
time frame: Pre-dose through 72 hours post dose
description: Concentration time data for MRX-4 and its metabolites in blood and urine
measure: Summary of the plasma concentration teim data for MRX-4 under fed or fasted conditions
time frame: Pre-dose through 72 hours post dose
description: Concentration time data for MRX-4 and its metabolites in blood and urine under fed and fasted conditions
measure: Safety of MRX-4 co-administered with omeprazole
time frame: Screening through end of study on Day 14
description: Summary of the number of subjects with changes in vital signs, physical examinations, clinical lab data, ecg parameters and adverse events
measure: Summary of the plasma concentration time data for MRX-4 co-administered with omeprazole
time frame: Pre-dose through 72 hours post dose
description: Concentation time data for MRX-4 and its metabolites in blood and urine with and without omeprazole
arm group label: Oral single doses of MRX-4
arm group type: Experimental
description: Single escalating oral doses of MRX-4 from 250 mg to 3000 mg
arm group label: Oral multiple doses of MRX-4
arm group type: Experimental
description: Twice daily escalating oral doses of MRX-4 for 10 days: 500 mg, 750 mg, 1000 mg, and 1500 mg
arm group label: MRX-4 co-administered with omeprazole
arm group type: Experimental
description: Impact of concomitant food or omeprazole on the pharmacokinetics of oral MRX-4.
arm group label: Oral single doses of placebo
arm group type: Placebo Comparator
description: Single oral doses of placebo to match MRX-4
arm group label: Oral multiple doses of placebo
arm group type: Placebo Comparator
description: Multiple oral doses of placebo given twice daily for 10 days to match MRX-4
arm group label: Placebo co-administered with omeprazole
arm group type: Placebo Comparator
description: Oral placebo given on Day 1, Day 7 to match MRX-4 dosing with omeprazole
intervention type: Drug
intervention name: Oral single doses of MRX-4
description: Oral single escalating doses of MRX-4
arm group label: Oral single doses of MRX-4
intervention type: Drug
intervention name: Oral multiple doses of MRX-4
description: Multiple ascending doses of MRX-4 given twice daily for 10 days
arm group label: Oral multiple doses of MRX-4
intervention type: Drug
intervention name: MRX-4 co-administered with omeprazole
description: MRX-4 given orally on Day 1 and Day 7, co-administered with omeprazole on Day 3 through Day 7
arm group label: MRX-4 co-administered with omeprazole
intervention type: Drug
intervention name: Oral single doses of placebo
description: Single doses of placebo to match MRX-4
arm group label: Oral single doses of placebo
intervention type: Drug
intervention name: Oral multiple doses of placebo
description: Oral placebo given twice daily for 10 days to match the oral MRX-4
arm group label: Oral multiple doses of placebo
intervention type: Drug
intervention name: Placebo co-administered with omeprazole
description: Placebo given orally on Day 1 and Day 7, co-administered with omeprazole on Day 3 through Day 7
arm group label: Placebo co-administered with omeprazole
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
mesh term: Omeprazole
sharing ipd: No
ipd description: The study results will be published in the future