<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/NCT02253342</url>
  </required_header>
  <id_info>
    <org_study_id>W-2349-103</org_study_id>
    <nct_id>NCT02253342</nct_id>
  </id_info>
  <brief_title>Study to Determine and Compare Plasma and Intrapulmonary Pharmacokinetics of WCK 2349 in Healthy Adult Human Subjects</brief_title>
  <official_title>A Phase 1, Multiple-Dose, Open-Label Study to Determine and Compare Plasma and Intrapulmonary Pharmacokinetics of WCK 2349 in Healthy Adult Human Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wockhardt</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Clinartis</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Wockhardt</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study to determine and compare plasma, epithelial lining fluid (ELF) and alveolar&#xD;
      macrophage (AM) concentrations of levonadifloxacin after administration of WCK 2349 in&#xD;
      healthy adult subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">December 2014</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Concentrations of levonadifloxacin in WCK 2349 Epithelial lining fluid (ELF) and alveolar macrophage (AM)</measure>
    <time_frame>5 days</time_frame>
    <description>Determine and compare plasma, epithelial lining fluid (ELF) and alveolar macrophage (AM) concentrations of levonadifloxacin after administration of WCK 2349</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Steady-state plasma pharmacokinetics of levonadifloxacin</measure>
    <time_frame>5 days</time_frame>
    <description>To compare the steady-state plasma pharmacokinetics of levonadifloxacin following administration of WCK 2349</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety and tolerability parameters-number of adverse event , change in clinical laboratory tests, ECG readings, change in physical examination and vital sign</measure>
    <time_frame>14 days</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Intrapulmonary Pharmacokinetics of WCK 2349</condition>
  <arm_group>
    <arm_group_label>WCK 2349</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive oral doses of WCK 2349 administered twice-daily for five days starting on Day 1</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>WCK-2349</intervention_name>
    <description>Each subject will receive ten oral doses of 1000 mg WCK 2349 administered twice-daily starting on Day 1</description>
    <arm_group_label>WCK 2349</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy adult males or females, 18 to 55 years of age (both inclusive) at the time of&#xD;
             screening.&#xD;
&#xD;
          -  Medical history without any major pathology as judged by the Principal Investigator.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History or presence of significant oncologic, cardiovascular, pulmonary, hepatic,&#xD;
             renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic,&#xD;
             neurological, or psychiatric disease.&#xD;
&#xD;
          -  Positive urine drug/alcohol testing at screening or confinement.&#xD;
&#xD;
          -  Positive testing for HIV, Hepatitis B or Hepatitis C.&#xD;
&#xD;
          -  History or presence of alcohol or drug abuse within the 2 years prior to screening.&#xD;
&#xD;
          -  Excessive intake of alcohol, defined as an average daily intake of greater than three&#xD;
             units, or an average weekly intake of greater than 21 units (one unit is equivalent to&#xD;
             1 can or bottle (12 oz) of beer, or 1 measure (1.5 oz) of spirits, or 1 glass (5 oz)&#xD;
             of wine) in the last 6 months prior to screening.&#xD;
&#xD;
          -  Known hypersensitivity to quinolones/fluoroquinolones.&#xD;
&#xD;
          -  History of allergic or other serious adverse reactions to benzodiazepines or&#xD;
             lidocaine.&#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>Mark H Gotfried, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pulmonary Associates, PA</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pulmonary Associates, 1112 E. McDowell Rd.</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85006</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2015</verification_date>
  <study_first_submitted>September 23, 2014</study_first_submitted>
  <study_first_submitted_qc>September 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2014</study_first_posted>
  <last_update_submitted>October 28, 2015</last_update_submitted>
  <last_update_submitted_qc>October 28, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 29, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Levonadifloxacin</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/NCT02253342
org study id: W-2349-103
nct id: NCT02253342
lead sponsor: 
collaborator: 
has dmc: No
This study to determine and compare plasma, epithelial lining fluid (ELF) and alveolar
      macrophage (AM) concentrations of levonadifloxacin after administration of WCK 2349 in
      healthy adult subjects.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Concentrations of levonadifloxacin in WCK 2349 Epithelial lining fluid (ELF) and alveolar macrophage (AM)
time frame: 5 days
description: Determine and compare plasma, epithelial lining fluid (ELF) and alveolar macrophage (AM) concentrations of levonadifloxacin after administration of WCK 2349
measure: Steady-state plasma pharmacokinetics of levonadifloxacin
time frame: 5 days
description: To compare the steady-state plasma pharmacokinetics of levonadifloxacin following administration of WCK 2349
measure: Safety and tolerability parameters-number of adverse event , change in clinical laboratory tests, ECG readings, change in physical examination and vital sign
time frame: 14 days
arm group label: WCK 2349
arm group type: Experimental
description: Subjects will receive oral doses of WCK 2349 administered twice-daily for five days starting on Day 1
intervention type: Drug
intervention name: WCK-2349
description: Each subject will receive ten oral doses of 1000 mg WCK 2349 administered twice-daily starting on Day 1
arm group label: WCK 2349
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mark H Gotfried, MD
role: Principal Investigator
affiliation: Pulmonary Associates, PA
facility: 
country: United States
responsible party type: Sponsor
mesh term: Levonadifloxacin