<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/NCT02245243</url>
  </required_header>
  <id_info>
    <org_study_id>ML-3341-112</org_study_id>
    <nct_id>NCT02245243</nct_id>
  </id_info>
  <brief_title>Pharmacokinetics of Delafloxacin in Subjects With and Without Hepatic Impairment</brief_title>
  <official_title>An Open Label Evaluation of the Single Dose Pharmacokinetics of Delafloxacin in Subjects With and Without Hepatic Impairment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Melinta Therapeutics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Melinta Therapeutics, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the pharmacokinetic profile, safety, and&#xD;
      tolerability of a single intravenous (IV) dose of delafloxacin in normal healthy subjects and&#xD;
      subjects with mild, moderate, or severe hepatic impairment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      pharmacokinetic profile, safety, and tolerability of a single intravenous (IV) dose of&#xD;
      delafloxacin in normal healthy subjects and subjects with mild, moderate, or severe hepatic&#xD;
      impairment. AUC0-t, AUC0 inf, Cmax, Tmax, λz, t1/2, MRTinf, CL, CLnr, Vss, Vz&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Plasma pharmacokinetic parameters: • AUC0-t, AUC0 inf, Cmax, Tmax, λz, t1/2, MRTinf, CL, CLnr, Vss, Vz</measure>
    <time_frame>Baseline through 72 hours post-dose</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety endpoints: AEs, clinical laboratory results (serum chemistry, coagulation, hematology, and urinalysis), vital sign measurements, 12-lead ECG measurements, and physical examination findings</measure>
    <time_frame>Baseline through 72 hours post-dose</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Hepatic Impairment</condition>
  <arm_group>
    <arm_group_label>Delafloxacin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single Dose 300 mg IV</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Delafloxacin</intervention_name>
    <description>Plasma pharmacokinetic parameters: AUC0-t, AUC0 inf, Cmax, Tmax, λz, t1/2, MRTinf, CL, CLnr, Vss, Vz</description>
    <arm_group_label>Delafloxacin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Body mass index (BMI) between 18.5 and 40 kg/m2, inclusive.&#xD;
&#xD;
          -  Able to provide written, informed consent before initiation of any study related&#xD;
             procedures, and is able, in the opinion of the investigator, to comply with all the&#xD;
             requirements of the study.&#xD;
&#xD;
        Hepatically Impaired Subjects Only (Groups A, B, and C):&#xD;
&#xD;
        -Has a clinical diagnosis of cirrhosis and has been classified as having mild (Group A),&#xD;
        moderate (Group B), or severe (Group C) hepatic impairment as defined by the Child-Pugh&#xD;
        classification system (Section 7.2).&#xD;
&#xD;
        Healthy Subjects Only (Group D):&#xD;
&#xD;
        -Must be in good health as determined by the investigator based on medical history,&#xD;
        clinical laboratory results, vital sign measurements, 12 lead electrocardiogram [ECG]&#xD;
        results, and physical examination findings&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  All Subjects (Groups A through D):&#xD;
&#xD;
          -  Has a clinically significant abnormality in past medical history or at the screening&#xD;
             physical examination (excluding hepatic impairment and other related stable medical&#xD;
             conditions within the hepatically impaired population of subjects) that in the&#xD;
             investigator's or sponsor's opinion may place the subject at risk or interfere with&#xD;
             outcome variables of the study. This includes, but is not limited to, history or&#xD;
             current cardiac, renal, neurologic, gastrointestinal, respiratory, hematologic, or&#xD;
             immunologic disease.&#xD;
&#xD;
          -  History or presence of an abnormal ECG that, in the investigator's opinion, is&#xD;
             clinically significant and would preclude study participation.&#xD;
&#xD;
          -  Has any surgical or medical condition (active or chronic) that may interfere with drug&#xD;
             absorption, distribution, metabolism, or excretion of the study drug, or any other&#xD;
             condition that may place the subject at risk (history of cholecystectomy is allowed).&#xD;
&#xD;
          -  Has a functioning liver transplant&#xD;
&#xD;
          -  Has a history of drug and/or alcohol abuse within 6 months before Screening&#xD;
&#xD;
          -  Has a history of or current clinically significant mental disorder or an antagonistic&#xD;
             personality that compromises the validity of the informed consent.&#xD;
&#xD;
          -  Has donated blood or plasma within 30 days before dosing, or has lost more than 1200&#xD;
             mL of blood within 4 months before the first dose of study drug.&#xD;
&#xD;
          -  Has a history of AIDS or subject has positive results for HIV at Screening.&#xD;
&#xD;
        Hepatically Impaired Subjects Only (Groups A, B, and C):&#xD;
&#xD;
          -  Has had clinical exacerbation of liver disease within 14 days before study drug&#xD;
             administration (eg, abdominal pain, ascites, nausea, vomiting, anorexia, fever, or&#xD;
             worsening of laboratory results related to hepatic function).&#xD;
&#xD;
          -  Has evidence of acute viral hepatitis within 1 month before Day -1, has clinically&#xD;
             demonstrable massive tense ascites, has evidence of severe or acute renal failure, has&#xD;
             active stage 3 or stage 4 encephalopathy.&#xD;
&#xD;
        Healthy Subjects Only (Group D):&#xD;
&#xD;
        -Has a positive test result for hepatitis B surface antigen or hepatitis C virus antibody.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sue K Cammarata, MD</last_name>
    <role>Study Director</role>
    <affiliation>CMO, MelintaTtherapeutics, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Melinta 112 Study Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Melinta 112 Study Site</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32809</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2015</verification_date>
  <study_first_submitted>September 17, 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>April 29, 2015</last_update_submitted>
  <last_update_submitted_qc>April 29, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 30, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hepatic Impairment, single dose, intravenous</keyword>
  <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>Delafloxacin</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/NCT02245243
org study id: ML-3341-112
nct id: NCT02245243
lead sponsor: 
has dmc: Yes
The purpose of this study is to evaluate the pharmacokinetic profile, safety, and
      tolerability of a single intravenous (IV) dose of delafloxacin in normal healthy subjects and
      subjects with mild, moderate, or severe hepatic impairment.
pharmacokinetic profile, safety, and tolerability of a single intravenous (IV) dose of
      delafloxacin in normal healthy subjects and subjects with mild, moderate, or severe hepatic
      impairment. AUC0-t, AUC0 inf, Cmax, Tmax, λz, t1/2, MRTinf, CL, CLnr, Vss, Vz
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Plasma pharmacokinetic parameters: • AUC0-t, AUC0 inf, Cmax, Tmax, λz, t1/2, MRTinf, CL, CLnr, Vss, Vz
time frame: Baseline through 72 hours post-dose
measure: Safety endpoints: AEs, clinical laboratory results (serum chemistry, coagulation, hematology, and urinalysis), vital sign measurements, 12-lead ECG measurements, and physical examination findings
time frame: Baseline through 72 hours post-dose
arm group label: Delafloxacin
arm group type: Experimental
description: Single Dose 300 mg IV
intervention type: Drug
intervention name: Delafloxacin
description: Plasma pharmacokinetic parameters: AUC0-t, AUC0 inf, Cmax, Tmax, λz, t1/2, MRTinf, CL, CLnr, Vss, Vz
arm group label: Delafloxacin
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sue K Cammarata, MD
role: Study Director
affiliation: CMO, MelintaTtherapeutics, Inc.
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Liver Diseases
mesh term: Delafloxacin