<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/NCT02217930</url>
  </required_header>
  <id_info>
    <org_study_id>W-2349-101</org_study_id>
    <nct_id>NCT02217930</nct_id>
  </id_info>
  <brief_title>Study to Evaluate the Effect Of WCK 2349 on the QT/QTc Interval in Health Volunteers</brief_title>
  <official_title>A Randomized, Double-Blind, Double-Dummy, Placebo- and Positive- Controlled, Crossover Study to Evaluate the Effect Of WCK 2349 on the QT/QTc Interval in Health Volunteers</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>
      The study designed to determine the effect induced by WCK 2349 on the QT interval.&#xD;
&#xD;
      The study will be conducted in two parts: 1) to determine the supratherapeutic dose; and 2)&#xD;
      to assess the safety of high doses of single-dose administration of WCK 2349 on the QT&#xD;
      interval.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Part 1 of this study will determine the supratherapeutic dose to be used in Part 2. Part&#xD;
      1will enroll 8 subjects at each of 4 dose levels (up to 32 subjects). Cohorts will be&#xD;
      staggered so that appropriate safety monitoring and follow-up can be performed for each&#xD;
      subject at each dose level.&#xD;
&#xD;
      Safety monitoring will be based upon review of AEs, ECGs and clinical laboratory test results&#xD;
      prior to escalation to the next dose level.&#xD;
&#xD;
      At the first dose level, 6 subjects will be randomly assigned to receive a single dose of WCK&#xD;
      2349 at 1800 mg and 2 subjects will be randomly assigned to placebo. If this dose is&#xD;
      tolerated by subjects, and safety data allows, the next group will be initiated in the same&#xD;
      fashion at a dose of 2200 mg. If this dose is tolerated by subjects, and safety data allows,&#xD;
      the next group will be initiated in the same fashion at a dose of 2600 mg. If this dose is&#xD;
      tolerated by subjects, and safety data allows, the next group will be initiated in the same&#xD;
      fashion at a dose of 3000 mg. Based upon safety data, the highest safely tolerated dose in&#xD;
      Part 1 will be utilized as the supratherapeutic dose in Part 2.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">July 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>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in QTc interval</measure>
    <time_frame>Baseline and 48 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Highest dose of WCK 2349 tolerated</measure>
    <time_frame>Baseline and 48 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Adverse Events</measure>
    <time_frame>Baseline and 7 days after the last dose</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Qt Interval, Variation in</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo matched to WCK 2349, oral tablet(s)&#xD;
Placebo matched to moxifloxacin overencapsulated tablet</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Moxifloxacin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Moxifloxacin 400 mg positive control (overencapsulated tablet)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>WCK 2349</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>WCK 2349 supratherapeutic dose determined in Part 1, oral tablet(s)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>WCK 2349</intervention_name>
    <arm_group_label>WCK 2349</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Moxifloxacin</intervention_name>
    <arm_group_label>Moxifloxacin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female subject between 18 and 55 years of age,inclusive, with a body mass&#xD;
             index ≥18 to ≤33 kg/m2.&#xD;
&#xD;
          -  Female subjects must be at least 2 years postmenopausal,surgically sterile, or&#xD;
             practicing 2 highly effective methods of birth control (determined by the investigator&#xD;
             or designee; one of the methods must be a barrier technique), not pregnant or&#xD;
             lactating, and have a negative serum pregnancy test before enrolling in the study.&#xD;
&#xD;
          -  Male or female subjects must agree to practice 2 highly effective methods of birth&#xD;
             control (as determined by the investigator or designee; one of the methods must be a&#xD;
             barrier technique) from Screening until 30 days after the last dose of study drug.&#xD;
&#xD;
          -  Stable health based on no clinically significant findings on the medical history,&#xD;
             physical examination, or clinical laboratory test results (as determined and&#xD;
             documented by the investigator).&#xD;
&#xD;
          -  Willing to comply with all study activities and procedures and provides written&#xD;
             informed consent prior to any study procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. An uninterpretable or abnormal screening electrocardiogram (ECG) indicating a second-&#xD;
             or third-degree atrioventricular block, or one or more of the following: QRS interval&#xD;
             &gt;110 milliseconds (msec); QT interval corrected by Fridericia's formula (QTcF) &gt;430&#xD;
             msec (males) and &gt;450 msec (females); PR interval &gt;200 msec; heart rate (HR) &lt;45 bpm;&#xD;
             or any rhythm other than sinus rhythm that is interpreted by the investigator to be&#xD;
             clinically significant.&#xD;
&#xD;
          2. History of risk factors for torsades de pointes, including unexplained syncope, known&#xD;
             long QT syndrome, heart failure, myocardial infarction, angina, or clinically&#xD;
             significant abnormal laboratory assessments including hypokalemia, hypercalcemia, or&#xD;
             hypomagnesemia. Subjects will also be excluded if there is a family history of long QT&#xD;
             syndrome or Brugada syndrome.&#xD;
&#xD;
          3. A sustained supine systolic blood pressure &gt;150 mm Hg or &lt;90 mm Hg or a supine&#xD;
             diastolic blood pressure &gt;95 mm Hg or &lt;50 mm Hg at Screening or Check-in (Day -1).&#xD;
             Blood pressure may be retested once in the supine position. The blood pressure&#xD;
             abnormality is considered sustained if either the systolic or the diastolic pressure&#xD;
             values are outside the stated limits after 2 assessments, and the subject may not be&#xD;
             randomized.&#xD;
&#xD;
          4. A resting HR of &lt;40 beats per minute or &gt;100 beats per minute when vital signs are&#xD;
             measured at Screening or Check-in (Day -1).&#xD;
&#xD;
          5. Unstable cardiovascular disease, including recent myocardial infarction or cardiac&#xD;
             arrhythmia.&#xD;
&#xD;
          6. Uncontrolled hypertension, asthma, unstable diabetes (type I or type II), thyroid&#xD;
             disease, seizures, myasthenia gravis, or any other neuromuscular disorder.&#xD;
&#xD;
          7. Women who are pregnant (or planning to become pregnant within the next 6 months) or&#xD;
             currently breastfeeding.&#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>Carlos Sanabria, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Spaulding Clinical Research Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Phase 1 unit : Spaulding Clinical Research, LLC</name>
      <address>
        <city>West Bend</city>
        <state>Wisconsin</state>
        <zip>53095</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>July 31, 2014</study_first_submitted>
  <study_first_submitted_qc>August 13, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 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>
  <keyword>TQT</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Moxifloxacin</mesh_term>
    <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/NCT02217930
org study id: W-2349-101
nct id: NCT02217930
lead sponsor: 
has dmc: No
The study designed to determine the effect induced by WCK 2349 on the QT interval.

      The study will be conducted in two parts: 1) to determine the supratherapeutic dose; and 2)
      to assess the safety of high doses of single-dose administration of WCK 2349 on the QT
      interval.
Part 1 of this study will determine the supratherapeutic dose to be used in Part 2. Part
      1will enroll 8 subjects at each of 4 dose levels (up to 32 subjects). Cohorts will be
      staggered so that appropriate safety monitoring and follow-up can be performed for each
      subject at each dose level.

      Safety monitoring will be based upon review of AEs, ECGs and clinical laboratory test results
      prior to escalation to the next dose level.

      At the first dose level, 6 subjects will be randomly assigned to receive a single dose of WCK
      2349 at 1800 mg and 2 subjects will be randomly assigned to placebo. If this dose is
      tolerated by subjects, and safety data allows, the next group will be initiated in the same
      fashion at a dose of 2200 mg. If this dose is tolerated by subjects, and safety data allows,
      the next group will be initiated in the same fashion at a dose of 2600 mg. If this dose is
      tolerated by subjects, and safety data allows, the next group will be initiated in the same
      fashion at a dose of 3000 mg. Based upon safety data, the highest safely tolerated dose in
      Part 1 will be utilized as the supratherapeutic dose in Part 2.
allocation: Randomized
intervention model: Crossover Assignment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Change in QTc interval
time frame: Baseline and 48 hours
measure: Highest dose of WCK 2349 tolerated
time frame: Baseline and 48 hours
measure: Number of Adverse Events
time frame: Baseline and 7 days after the last dose
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo matched to WCK 2349, oral tablet(s)
Placebo matched to moxifloxacin overencapsulated tablet
arm group label: Moxifloxacin
arm group type: Active Comparator
description: Moxifloxacin 400 mg positive control (overencapsulated tablet)
arm group label: WCK 2349
arm group type: Experimental
description: WCK 2349 supratherapeutic dose determined in Part 1, oral tablet(s)
intervention type: Drug
intervention name: WCK 2349
arm group label: WCK 2349
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
intervention type: Drug
intervention name: Moxifloxacin
arm group label: Moxifloxacin
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Carlos Sanabria, MD
role: Principal Investigator
affiliation: Spaulding Clinical Research Inc.
facility: 
country: United States
responsible party type: Sponsor
mesh term: Moxifloxacin
mesh term: Levonadifloxacin