<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/NCT02244827</url>
  </required_header>
  <id_info>
    <org_study_id>W-2349-102</org_study_id>
    <nct_id>NCT02244827</nct_id>
  </id_info>
  <brief_title>Pharmacokinetics of WCK 2349 In Patients With Hepatic Impairment</brief_title>
  <official_title>A Phase I, Open Label, Single Dose Study to Evaluate The Pharmacokinetics of WCK 2349 In Patients With Hepatic Impairment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wockhardt</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wockhardt</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is aimed to compare the pharmacokinetics of levonadifloxacin and its sulfate&#xD;
      metabolite after a single dose of oral WCK 2349 1000 mg in patients with hepatic impairment&#xD;
      and healthy volunteers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">June 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>To compare the pharmacokinetics parameters -AUC,Cmax, tmax, λz, t1/2, systemic clearance and apparent volume of distribution.</measure>
    <time_frame>48 hours</time_frame>
    <description>To compare the pharmacokinetics of levonadifloxacin and its sulfate metabolite after a single dose of oral WCK 2349 in patients with hepatic impairment and healthy volunteers</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To evaluate the safety and tolerability parameters- Number of AE , Vital signs, clinical laboratory values, abnormal physical examinations and ECGs</measure>
    <time_frame>7 weeks</time_frame>
    <description>To evaluate the safety and tolerability of oral WCK 2349 in patients with hepatic impairment and healthy volunteers</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Hepatic Impairment</condition>
  <arm_group>
    <arm_group_label>WCK 2349</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each subject will receive a single oral dose of WCK 2349 1000 mg (i.e., 2 tablets of 400 mg and 1 tablet of 200 mg) with 240 mL water on Day 1 in the morning. Study drug will be administered after a fast of at least 8 hours.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>WCK 2349</intervention_name>
    <description>levonadifloxacin (active drug) and the sulfate metabolite</description>
    <arm_group_label>WCK 2349</arm_group_label>
    <other_name>levonadifloxacin (active drug)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Body Mass Index (BMI): 18.0 - 38.0 (Body weight in kg / Height in m2), both inclusive.&#xD;
&#xD;
          -  Subjects must fulfill the following criteria:&#xD;
&#xD;
        Patients with hepatic impairment:&#xD;
&#xD;
          -  Considered clinically stable in the opinion of the Investigator&#xD;
&#xD;
          -  Patients with different degrees of impaired hepatic function as assessed by a&#xD;
             Child-Pugh classification score: mild (5-6 points), moderate (7-9 points) and severe&#xD;
             (10-15 points) impaired hepatic function.&#xD;
&#xD;
          -  Documented history of cirrhosis diagnosed by liver biopsy, ultrasonography (USG),&#xD;
             computed tomography (CT) scan, or magnetic resonance imaging (MRI) OR&#xD;
&#xD;
        Healthy volunteers:&#xD;
&#xD;
          -  Have normal hepatic function&#xD;
&#xD;
          -  Participants with a history of self-limited hepatitis A with complete resolution&#xD;
             documented at least 6 months prior to entry will be allowed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known hypersensitivity to quinolones/fluoroquinolones.&#xD;
&#xD;
          -  Subjects must not fulfill the following criteria:&#xD;
&#xD;
        In hepatically impaired patients:&#xD;
&#xD;
          -  Use of prohibited concomitant medication, with the exception of those essential for&#xD;
             the management of hepatic impairment and the treatment of concomitant stable medical&#xD;
             conditions for the hepatically impaired patients as per the discretion of the&#xD;
             Investigator.&#xD;
&#xD;
          -  Fluctuating or rapidly deteriorating hepatic function as indicated by recent history&#xD;
             or widely varying or worsening of clinical and/or laboratory signs of hepatic&#xD;
             impairment as judged by the Investigator.&#xD;
&#xD;
          -  Concomitant treatment with Interferon or other prohibited medications&#xD;
&#xD;
          -  Active stage 3 and stage 4 encephalopathy OR&#xD;
&#xD;
        Healthy Volunteers:&#xD;
&#xD;
          -  Use of any concomitant medication within 7 days from the screening except those deemed&#xD;
             safe for the study by the Investigator and Medical Monitor.&#xD;
&#xD;
          -  History of any clinically significant chronic and/or active hepatic disease including&#xD;
             elevations of serum transaminases including aspartate aminotransferase (AST) and&#xD;
             alanine aminotransferase (ALT) [except those which are considered non-significant by&#xD;
             the Investigator; however, these should not exceed 1.5 times the Upper Limit of Normal&#xD;
             (ULN)], hepatitis (Hepatitis A, B or C), biliary tract disease, or history of any&#xD;
             significant gastrointestinal surgery.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Richard A Preston, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Division of Clinical Pharmacology,University of Miami</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Miami,Division of Clinical Pharmacology</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</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 10, 2014</study_first_submitted>
  <study_first_submitted_qc>September 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 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>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Diseases</mesh_term>
  </condition_browse>
  <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/NCT02244827
org study id: W-2349-102
nct id: NCT02244827
lead sponsor: 
has dmc: No
This study is aimed to compare the pharmacokinetics of levonadifloxacin and its sulfate
      metabolite after a single dose of oral WCK 2349 1000 mg in patients with hepatic impairment
      and healthy volunteers.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: To compare the pharmacokinetics parameters -AUC,Cmax, tmax, λz, t1/2, systemic clearance and apparent volume of distribution.
time frame: 48 hours
description: To compare the pharmacokinetics of levonadifloxacin and its sulfate metabolite after a single dose of oral WCK 2349 in patients with hepatic impairment and healthy volunteers
measure: To evaluate the safety and tolerability parameters- Number of AE , Vital signs, clinical laboratory values, abnormal physical examinations and ECGs
time frame: 7 weeks
description: To evaluate the safety and tolerability of oral WCK 2349 in patients with hepatic impairment and healthy volunteers
arm group label: WCK 2349
arm group type: Experimental
description: Each subject will receive a single oral dose of WCK 2349 1000 mg (i.e., 2 tablets of 400 mg and 1 tablet of 200 mg) with 240 mL water on Day 1 in the morning. Study drug will be administered after a fast of at least 8 hours.
intervention type: Drug
intervention name: WCK 2349
description: levonadifloxacin (active drug) and the sulfate metabolite
arm group label: WCK 2349
other name: levonadifloxacin (active drug)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Richard A Preston, M.D.
role: Principal Investigator
affiliation: Division of Clinical Pharmacology,University of Miami
facility: 
country: United States
responsible party type: Sponsor
mesh term: Liver Diseases
mesh term: Levonadifloxacin