<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/NCT01706679</url>
  </required_header>
  <id_info>
    <org_study_id>ATX-101-11-24</org_study_id>
    <nct_id>NCT01706679</nct_id>
  </id_info>
  <brief_title>Evaluation of the Effect of ATX-101 on QT/QTc Intervals</brief_title>
  <acronym>ATX-101-11-24</acronym>
  <official_title>A Four-Arm, Parallel Design, Randomized, Double-Blinded, Placebo and Active Controlled Study for the Evaluation of the Effect of Maximum Therapeutic and Supratherapeutic Single-Dose ATX-101 on the QT/QTc Intervals in Healthy Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kythera Biopharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kythera Biopharmaceuticals</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the effect of maximum therapeutic and supratherapeutic doses of ATX-101 treatment&#xD;
      on Fridericia's corrected QT interval (QTcF).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">June 2013</completion_date>
  <primary_completion_date type="Actual">February 2013</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>Treatment</primary_purpose>
    <masking>Double</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The effect of maximum therapeutic and supratherapeutic doses of ATX-101 treatment on Fridericia's corrected QT interval (QTcF)</measure>
    <time_frame>2.5 days</time_frame>
    <description>The primary endpoint will be the mean change between time-matched measurements of QTcF for ATX-101 and placebo after baseline adjustment calculating the upper bound of the one-sided 95% confidence interval. A negative TQT study can be claimed if each upper bound of the one-sided 95% CI is below 10 msec.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To evaluate change from placebo and baseline of the maximum therapeutic and supratherapeutic doses of ATX-101 treatment on QT interval corrected for individuals</measure>
    <time_frame>2.5 days</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">218</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Maximum therapeutic dose of ATX-101</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>ATX-101 10 mg/ml</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Supratherapeutic dose of ATX-101</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>ATX-101 20 mg/ml</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Moxifloxacin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>moxifloxacin (400mg)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo vehicle</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>placebo vehicle (PBS)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ATX-101 (10 mg/ml)</intervention_name>
    <arm_group_label>Maximum therapeutic dose of ATX-101</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ATX-101 (20 mg/ml)</intervention_name>
    <arm_group_label>Supratherapeutic dose of ATX-101</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Moxifloxacin (400 mg)</intervention_name>
    <arm_group_label>Moxifloxacin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo vehicle (PBS)</intervention_name>
    <arm_group_label>Placebo vehicle</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males or nonpregnant, nonlactating females who are aged 18 to 65 years (inclusive).&#xD;
             Females must have a negative serum human chorionic gonadotropin (hCG) test result from&#xD;
             a sample obtained during the screening period and after admission to the research&#xD;
             facility, but before the dose of study material. Females of postmenopausal status must&#xD;
             not have had menses for at least one year and if younger than 55 years of age must&#xD;
             have a serum FSH level ≥ 35 mIU/mL. Females of childbearing potential must agree to&#xD;
             practice adequate contraception, in the judgment of the investigator, during the&#xD;
             course of the trial.&#xD;
&#xD;
          -  Body Mass Index (BMI) in the range of 20 - 38 kg/m2 (inclusive). Refer to Appendix A.&#xD;
&#xD;
          -  Presence of sufficient submental fat into which 25 subcutaneous injections spaced on a&#xD;
             1.0-cm grid can be safely administered based on the investigator's judgment.&#xD;
&#xD;
          -  Normal vital signs after 10 minutes resting in a supine position:&#xD;
&#xD;
               -  Systolic Blood Pressure: 90 mm Hg to 140 mm Hg&#xD;
&#xD;
               -  Diastolic Blood Pressure: 45 mm Hg to 90 mm Hg&#xD;
&#xD;
               -  Heart Rate: 45 bpm to 100 bpm&#xD;
&#xD;
          -  Normal Resting ECG&#xD;
&#xD;
               -  PR Interval: 120 msec to 220 msec&#xD;
&#xD;
               -  QRS Duration: &lt; 120 msec&#xD;
&#xD;
               -  QTcF Duration: &lt; 450 msec&#xD;
&#xD;
          -  Serum hemoglobin test result of 11.0 g/dL or greater and negative hepatitis B,&#xD;
             hepatitis C, and HIV test result within 28 days before the dose of study material.&#xD;
&#xD;
          -  Willing and able to comply with and understand the visit schedule and all of the&#xD;
             protocol-specified tests and procedures.&#xD;
&#xD;
          -  Medically able to undergo the administration of study material as determined by&#xD;
             clinical and laboratory evaluations obtained within 28 days before dosing with study&#xD;
             material for which the investigator identifies no clinically significant abnormality.&#xD;
&#xD;
          -  Signed informed consent obtained before any study-specific procedure is conducted.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any prescription medication taken within 14 days (or 5 elimination half-lives,&#xD;
             whichever is longer) of Study Day -2, or have taken any over-the-counter medications,&#xD;
             including topical medications, herbal or dietary supplements/remedies within 7 days of&#xD;
             Study Day 2, or planned concomitant medication while in the study (except for&#xD;
             acetaminophen up to 2 g/day and hormonal birth control).&#xD;
&#xD;
          -  A history of additional risk factors for Torsade de Pointes (e.g. hypokalemia, history&#xD;
             of drowning survival, family history of Long QT Syndrome, family history of Short QT&#xD;
             Syndrome, or family history of unexplainable early sudden death).&#xD;
&#xD;
          -  Participation in a study of an investigational drug or device within 30 days prior to&#xD;
             the baseline ECG.&#xD;
&#xD;
          -  Any condition that, in the judgment of the investigator, would place a subject at&#xD;
             undue risk, or potentially compromise the results or interpretation of the study.&#xD;
&#xD;
          -  Uncontrolled cardiac arrhythmias, for example, atrial fibrillation with a ventricular&#xD;
             response at rest &gt; 100 beats per minute.&#xD;
&#xD;
          -  Known abnormality of any cardiac valve (either stenosis or regurgitation) that is&#xD;
             greater than moderate in severity.&#xD;
&#xD;
          -  Subjects not in sinus rhythm at screening.&#xD;
&#xD;
          -  Hypersensitivity to Moxifloxacin&#xD;
&#xD;
          -  History or presence of significant cardiovascular, pulmonary, hepatic, renal,&#xD;
             hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or&#xD;
             psychiatric disease.&#xD;
&#xD;
          -  Use of tobacco or nicotine-containing products within 3 months prior to dose.&#xD;
&#xD;
          -  History of any intervention to treat submental fat (e.g. liposuction, surgery, or&#xD;
             lipolytic agents).&#xD;
&#xD;
          -  History of trauma associated with the chin or neck areas, which in the judgment of the&#xD;
             investigator may affect evaluation of safety of treatment.&#xD;
&#xD;
          -  Loose skin in the neck or chin area for which reduction in submental fat may, in the&#xD;
             judgment of the investigator, result in a cosmetically unacceptable outcome.&#xD;
&#xD;
          -  Prominent platysmal bands at rest that interfere with the evaluation of submental fat.&#xD;
&#xD;
          -  Evidence of any cause of enlargement in the submental area other than localized&#xD;
             subcutaneous fat.&#xD;
&#xD;
          -  Any blood donation or significant blood loss within 56 days before the dose of study&#xD;
             material or plasma donation within 7 days of Day -1.&#xD;
&#xD;
          -  A result on coagulation tests (PT, PTT) obtained within 28 days before the dose of&#xD;
             study material that indicates the presence of any clinically significant bleeding&#xD;
             disorder.&#xD;
&#xD;
          -  Any medical condition that would interfere with the assessment of safety in this trial&#xD;
             or would compromise the ability of the subject to undergo study procedures or to give&#xD;
             informed consent.&#xD;
&#xD;
          -  Treatment with oral anticoagulants (e.g. warfarin) within 30 days before dosing with&#xD;
             study material.&#xD;
&#xD;
          -  Treatment with radio frequency, laser procedure, chemical peels, or dermal fillers in&#xD;
             the neck or chin within 12 months before dosing with the study material, or botulinum&#xD;
             toxin injections in the neck or chin area within 6 months before dosing with the study&#xD;
             material.&#xD;
&#xD;
          -  History of sensitivity to any components of the study material.&#xD;
&#xD;
          -  History of drug or alcohol abuse, in the judgment of the investigator, within two&#xD;
             years before dosing with the study material.&#xD;
&#xD;
          -  Presence of positive urine drug or alcohol screening test result obtained from a&#xD;
             sample obtained during the screening period and/or after admission to the research&#xD;
             facility for the confinement period, but before dosing with the study material.&#xD;
&#xD;
          -  Previous enrollment in a trial of ATX-101.&#xD;
&#xD;
          -  Treatment with an investigational device or agent within 30 days prior to the baseline&#xD;
             ECG.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Royce Morrison, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Comprehensive Clinical Development</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Comprehensive Clinical Development</name>
      <address>
        <city>Miramar</city>
        <state>Florida</state>
        <zip>33027</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 11, 2012</study_first_submitted>
  <study_first_submitted_qc>October 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2012</study_first_posted>
  <last_update_submitted>November 12, 2013</last_update_submitted>
  <last_update_submitted_qc>November 12, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 14, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Healthy volunteers</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Moxifloxacin</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/NCT01706679
org study id: ATX-101-11-24
nct id: NCT01706679
lead sponsor: 
has dmc: No
To evaluate the effect of maximum therapeutic and supratherapeutic doses of ATX-101 treatment
      on Fridericia's corrected QT interval (QTcF).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double
measure: The effect of maximum therapeutic and supratherapeutic doses of ATX-101 treatment on Fridericia's corrected QT interval (QTcF)
time frame: 2.5 days
description: The primary endpoint will be the mean change between time-matched measurements of QTcF for ATX-101 and placebo after baseline adjustment calculating the upper bound of the one-sided 95% confidence interval. A negative TQT study can be claimed if each upper bound of the one-sided 95% CI is below 10 msec.
measure: To evaluate change from placebo and baseline of the maximum therapeutic and supratherapeutic doses of ATX-101 treatment on QT interval corrected for individuals
time frame: 2.5 days
arm group label: Maximum therapeutic dose of ATX-101
arm group type: Active Comparator
description: ATX-101 10 mg/ml
arm group label: Supratherapeutic dose of ATX-101
arm group type: Active Comparator
description: ATX-101 20 mg/ml
arm group label: Moxifloxacin
arm group type: Active Comparator
description: moxifloxacin (400mg)
arm group label: Placebo vehicle
arm group type: Placebo Comparator
description: placebo vehicle (PBS)
intervention type: Drug
intervention name: ATX-101 (10 mg/ml)
arm group label: Maximum therapeutic dose of ATX-101
intervention type: Drug
intervention name: ATX-101 (20 mg/ml)
arm group label: Supratherapeutic dose of ATX-101
intervention type: Drug
intervention name: Moxifloxacin (400 mg)
arm group label: Moxifloxacin
intervention type: Drug
intervention name: Placebo vehicle (PBS)
arm group label: Placebo vehicle
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Royce Morrison, MD, PhD
role: Principal Investigator
affiliation: Comprehensive Clinical Development
facility: 
country: United States
responsible party type: Sponsor
mesh term: Moxifloxacin