xml: <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/NCT05995444</url>
    </required_header>
    <id_info>
      <org_study_id>EBO-104</org_study_id>
      <nct_id>NCT05995444</nct_id>
    </id_info>
    <brief_title>A Study to Assess the Effects of Epetraborole on the QT Interval in Healthy Adult Subjects</brief_title>
    <official_title>A Phase 1, Single-Dose, Randomized, Placebo- and Positive-Control, Four-Way, Crossover Study for the Evaluation of the Effect of Epetraborole on QT Intervals in Healthy Adult Subjects</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>AN2 Therapeutics, Inc</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>AN2 Therapeutics, Inc</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        A single-center, 4-way crossover study to evaluate the effect of single therapeutic and&#xD;
        supratherapeutic oral doses of epetraborole on the heart rate (HR) corrected QT interval&#xD;
        (QTc) by assessing concentration-QT (C-QT) relationship using exposure-response modeling.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        On Day 1 of each period, subjects will receive 1 of 4 treatments: a single therapeutic dose&#xD;
        of epetraborole (Treatment A), a single supratherapeutic dose of epetraborole (Treatment B),&#xD;
        a single dose of epetraborole-matching placebo (Treatment C), or a single dose of&#xD;
        moxifloxacin (Treatment D). Cardiodynamic ECGs and PK blood samples for epetraborole,&#xD;
        metabolite M3, and moxifloxacin (as applicable) will be collected predose and for 24 hours&#xD;
        postdose in each period.&#xD;
  &#xD;
        There will be a washout of at least 10 days between doses.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">June 5, 2023</start_date>
    <completion_date type="Actual">August 4, 2023</completion_date>
    <primary_completion_date type="Actual">July 21, 2023</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>
      <intervention_model_description>Screening of subjects will occur within 28 days prior to the first dosing. Subjects will be housed on Day -1, at the time indicated by the CRU, until completion of study procedures on Day 2 of each period. On Day 1 of each period, subjects will receive 1 of 4 treatments: a single therapeutic dose of epetraborole (Treatment A), a single supratherapeutic dose of epetraborole (Treatment B), a single dose of epetraborole matching-placebo (Treatment C), or a single dose of moxifloxacin (Treatment D). Cardiodynamic ECGs and PK blood samples for epetraborole, metabolite M3, and moxifloxacin (as applicable) will be collected predose and for 24 hours postdose in each period. There will be a washout of at least 10 days between doses. Safety will be monitored throughout the study by repeated clinical and laboratory evaluations, including a follow-up visit approximately 14 days after the last dose.</intervention_model_description>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Changes to QTc interval</measure>
      <time_frame>Study Day -1 to Study Day 2</time_frame>
      <description>Effect of epetraborole plasma concentrations on the QTc interval using linear mixed effect exposure-response modeling, including the predicted ddQTc at Cmax values corresponding to exposure levels of interest.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Effect of epetraborole plasma concentrations on other ECG parameters on QTc</measure>
      <time_frame>Study Day -1 to Study Day 2</time_frame>
      <description>Measure the Effect of epetraborole plasma concentrations on other ECG parameters on QTc</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Assay sensitivity</measure>
      <time_frame>Study Day -1 to Study Day 2</time_frame>
      <description>Assay sensitivity assessment with ddQTc at the geometric mean Cmax value predicted from a linear mixed effect model evaluating the relationship between QTc and moxifloxacin plasma concentrations (exposure-response modeling).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Analysis of dQTc</measure>
      <time_frame>Study Day -1 to Study Day 2</time_frame>
      <description>QTc interval using a mixed effect analysis of covariance (ANCOVA) carried out as appropriate to analyze dQTc at each time point post baseline.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PK Concentration analysis for epetraborole and metabolite M3 of AUC0 t</measure>
      <time_frame>Study Day -1 to Study Day 2</time_frame>
      <description>Analysis of PK Concentration for epetraborole and metabolite M3 of AUC0 t</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evaluation of TEAEs</measure>
      <time_frame>Study Day 1 through Study Day 14</time_frame>
      <description>TEAEs</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Safety Vital Signs changes of body temperature</measure>
      <time_frame>Study Day 1 through Study Day 14</time_frame>
      <description>Measure Safety Vital Signs changes of body temperature</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Orthostatic Vital Signs changes of Heart Rate from supine to standing position.</measure>
      <time_frame>Study Day 1 through Study Day 14</time_frame>
      <description>Measure Orthostatic Vital Signs changes of Heart Rate from supine to standing position.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Effect of epetraborole plasma concentrations on other ECG parameters on, PR</measure>
      <time_frame>Study Day -1 to Study Day 2</time_frame>
      <description>Measure the Effect of epetraborole plasma concentrations on other ECG parameters on, PR</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Effect of epetraborole plasma concentrations on other ECG parameters on QRS duration</measure>
      <time_frame>Study Day -1 to Study Day 2</time_frame>
      <description>Measure the Effect of epetraborole plasma concentrations on other ECG parameters on QRS duration.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Effect of epetraborole plasma concentrations on other ECG parameters on HR.</measure>
      <time_frame>Study Day -1 to Study Day 2</time_frame>
      <description>Measure the Effect of epetraborole plasma concentrations on other ECG parameters on HR.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PK Concentration analysis for epetraborole and metabolite M3 of AUC0 inf</measure>
      <time_frame>Study Day -1 to Study Day 2</time_frame>
      <description>Analysis of PK Concentration for epetraborole and metabolite M3 of AUC0 inf</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PK Concentration analysis for epetraborole and metabolite M3 of AUC%extrap</measure>
      <time_frame>Study Day -1 to Study Day 2</time_frame>
      <description>Analysis of PK Concentration for epetraborole and metabolite M3 of AUC%extrap</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PK Concentration analysis for epetraborole and metabolite M3 of Cmax</measure>
      <time_frame>Study Day -1 to Study Day 2</time_frame>
      <description>Analysis of PK Concentration for epetraborole and metabolite M3 of Cmax</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PK Concentration analysis for epetraborole and metabolite M3 of Tmax</measure>
      <time_frame>Study Day -1 to Study Day 2</time_frame>
      <description>Analysis of PK Concentration for epetraborole and metabolite M3 of Tmax</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PK Concentration analysis for epetraborole and metabolite M3 of Kel</measure>
      <time_frame>Study Day -1 to Study Day 2</time_frame>
      <description>Analysis of PK Concentration for epetraborole and metabolite M3 of Kel</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PK Concentration analysis for epetraborole and metabolite M3 of t½</measure>
      <time_frame>Study Day -1 to Study Day 2</time_frame>
      <description>Analysis of PK Concentration for epetraborole and metabolite M3 of t½</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PK Concentration analysis for epetraborole and metabolite M3 of CL/F (parent only),</measure>
      <time_frame>Study Day -1 to Study Day 2</time_frame>
      <description>Analysis of PK Concentration for epetraborole and metabolite M3 of CL/F (parent only),</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PK Concentration analysis for epetraborole and metabolite M3 of Vz/F (parent only)</measure>
      <time_frame>Study Day -1 to Study Day 2</time_frame>
      <description>Analysis of PK Concentration for epetraborole and metabolite M3 of Vz/F (parent only</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PK Concentration analysis for epetraborole and metabolite M3 of MR AUC0 t</measure>
      <time_frame>Study Day -1 to Study Day 2</time_frame>
      <description>Analysis of PK Concentration for epetraborole and metabolite M3 of MR AUC0 t</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PK Concentration analysis for epetraborole and metabolite M3 of MR AUC0 inf</measure>
      <time_frame>Study Day -1 to Study Day 2</time_frame>
      <description>Analysis of PK Concentration for epetraborole and metabolite M3 of MR AUC0 inf</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PK Concentration analysis for epetraborole and metabolite M3 of MR Cmax</measure>
      <time_frame>Study Day -1 to Study Day 2</time_frame>
      <description>Analysis of PK Concentration for epetraborole and metabolite M3 of MR Cmax</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Safety Vital Signs changes of respiratory rate</measure>
      <time_frame>Study Day 1 through Study Day 14</time_frame>
      <description>Measure Safety Vital Signs changes of respiratory rate</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Safety Vital Signs changes of blood pressure</measure>
      <time_frame>Study Day 1 through Study Day 14</time_frame>
      <description>Measure Safety Vital Signs changes of blood pressure (systolic and diastolic)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Safety Vital Signs changes of heart rate</measure>
      <time_frame>Study Day 1 through Study Day 14</time_frame>
      <description>measure Safety Vital Signs changes of heart rate</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Orthostatic Vital Signs changes of blood pressure from supine to standing position.</measure>
      <time_frame>Study Day 1 through Study Day 14</time_frame>
      <description>Measure Orthostatic Vital Signs changes of blood pressure from supine to standing position (systolic and diastolic).</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Actual">24</enrollment>
    <condition>Healthy Volunteers</condition>
    <arm_group>
      <arm_group_label>500 mg epetraborole</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>500 mg epetraborole</description>
    </arm_group>
    <arm_group>
      <arm_group_label>2000 mg epetraborole</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>2000 mg epetraborole</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Epetraborole-matching placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Epetraborole-matching placebo</description>
    </arm_group>
    <arm_group>
      <arm_group_label>400 mg moxifloxacin</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>400 mg moxifloxacin</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Epetraborole and matching placebo</intervention_name>
      <description>Treatment A (Therapeutic): 500 mg epetraborole (2 x 250 mg tablets) and epetraborole matching-placebo (6 tablets)</description>
      <arm_group_label>Epetraborole-matching placebo</arm_group_label>
      <other_name>Therapeutic</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Epetraborole</intervention_name>
      <description>Treatment B (Supratherapeutic): 2000 mg epetraborole (8 x 250 mg tablets)</description>
      <arm_group_label>2000 mg epetraborole</arm_group_label>
      <arm_group_label>500 mg epetraborole</arm_group_label>
      <other_name>Supratherapeutic</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Treatment C (Placebo control): Epetraborole matching-placebo (8 tablets)</description>
      <arm_group_label>Epetraborole-matching placebo</arm_group_label>
      <other_name>Placebo Control</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Moxifloxacin</intervention_name>
      <description>Treatment D (Positive control): 400 mg moxifloxacin (1 x 400 mg tablet)</description>
      <arm_group_label>400 mg moxifloxacin</arm_group_label>
      <other_name>Positive Control</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. 1. Adult, male or female, 18-65 years of age, inclusive, at the screening visit.&#xD;
  &#xD;
            2. Subjects must agree to follow protocol-specified contraception guidance&#xD;
  &#xD;
            3. Continuous non smoker for at least 3 months prior to the first dosing based on subject&#xD;
               self-reporting&#xD;
  &#xD;
            4. Body mass index (BMI) 18.0 and 32.0 kg/m2 at the screening visit.&#xD;
  &#xD;
            5. Medically healthy with no clinically significant medical history, physical&#xD;
               examination, laboratory profiles, and vital signs, as deemed by the Investigator or&#xD;
               designee.&#xD;
  &#xD;
            6. No clinically significant history or presence of ECG findings as judged by the&#xD;
               Investigator or designee at the screening visit and first check-in&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Is mentally or legally incapacitated or has significant emotional problems at the time&#xD;
               of the screening visit or expected during the conduct of the study.&#xD;
  &#xD;
            2. History or presence of clinically significant medical or psychiatric condition or&#xD;
               disease that, in the opinion of the Investigator or designee, might confound the&#xD;
               results of the study or poses an additional risk to the subject by their participation&#xD;
               in the study.&#xD;
  &#xD;
            3. Presence of bacterial infections requiring the use of antibiotic therapy within 3&#xD;
               months prior to the first dosing.&#xD;
  &#xD;
            4. History or presence of alcohol or drug abuse within the past 2 years prior to the&#xD;
               first dosing.&#xD;
  &#xD;
            5. History of regular alcohol consumption exceeding 7 drinks/week for females or 14&#xD;
               drinks/week for males (1 drink = 5 ounces [150 mL] of wine or 12 ounces [360 mL] of&#xD;
               beer or 1.5 ounces [45 mL] of hard liquor) within 6 months prior to the first dosing.&#xD;
  &#xD;
            6. History or presence of hypersensitivity or idiosyncratic reaction to the study drugs&#xD;
               or related compounds (e.g., fluoroquinolones, epetraborole excipients), or allergy to&#xD;
               ECG electrode adhesive patches or adhesive dressings/medical tape.&#xD;
  &#xD;
            7. History or presence of any of the following, deemed clinically significant by the&#xD;
               Investigator or qualified designee:&#xD;
  &#xD;
                 1. Ventricular pre-excitation syndrome (Wolff Parkinson White syndrome)&#xD;
  &#xD;
                 2. Arrhythmia or history of arrhythmia requiring medical intervention&#xD;
  &#xD;
                 3. Risk factors for TdP (e.g., heart failure, cardiomyopathy, family history of Long&#xD;
                    QT Syndrome, or sudden unexpected cardiac death at a young age)&#xD;
  &#xD;
                 4. Sick sinus syndrome, second- or third-degree atrioventricular block, myocardial&#xD;
                    infarction, pulmonary congestion, symptomatic or significant cardiac arrhythmia,&#xD;
                    prolonged QTcF interval, or conduction abnormalities&#xD;
  &#xD;
            8. Is lactating or has a positive pregnancy test at the screening visit or first check-in&#xD;
               (females only).&#xD;
  &#xD;
            9. Positive urine drug or alcohol results at the screening visit or first check-in.&#xD;
  &#xD;
           10. Positive results for human immunodeficiency virus (HIV), hepatitis B surface antigen&#xD;
               (HBsAg), or hepatitis C virus (HCV) at the screening visit.&#xD;
  &#xD;
           11. Positive results for coronavirus disease 2019 (COVID-19) at first check-in.&#xD;
  &#xD;
           12. Unable to refrain from or anticipates the use of any drugs, including prescription and&#xD;
               non-prescription medications, herbal remedies, or vitamin supplements beginning&#xD;
  &#xD;
          14 days prior to the first dosing.&#xD;
  &#xD;
          13. Has been on a diet incompatible with the on-study diet, in the opinion of the&#xD;
          Investigator or designee, within the 30 days prior to the first dosing.&#xD;
  &#xD;
          14. Donation of blood or blood products or significant blood loss within 56 days prior to&#xD;
          the first dosing or plans to donate blood products through the follow-up contact.&#xD;
  &#xD;
          15. Participation in another clinical study and received an investigational agent within 30&#xD;
          days or within 5 half-lives (if known), prior to the first dosing, whichever is longer. The&#xD;
          30-day window will be derived from the date of the last blood collection or dosing,&#xD;
          whichever is later, in the previous study to Day 1 of Period 1 of the current study.&#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>
    <location>
      <facility>
        <name>423001</name>
        <address>
          <city>Tempe</city>
          <state>Arizona</state>
          <zip>85283</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 27, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>QTc</keyword>
    <keyword>Epetraborole</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>
  
  
text: 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/NCT05995444
  org study id: EBO-104
  nct id: NCT05995444
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: Yes
  A single-center, 4-way crossover study to evaluate the effect of single therapeutic and
        supratherapeutic oral doses of epetraborole on the heart rate (HR) corrected QT interval
        (QTc) by assessing concentration-QT (C-QT) relationship using exposure-response modeling.
  On Day 1 of each period, subjects will receive 1 of 4 treatments: a single therapeutic dose
        of epetraborole (Treatment A), a single supratherapeutic dose of epetraborole (Treatment B),
        a single dose of epetraborole-matching placebo (Treatment C), or a single dose of
        moxifloxacin (Treatment D). Cardiodynamic ECGs and PK blood samples for epetraborole,
        metabolite M3, and moxifloxacin (as applicable) will be collected predose and for 24 hours
        postdose in each period.
  
        There will be a washout of at least 10 days between doses.
  allocation: Randomized
  intervention model: Crossover Assignment
  intervention model description: Screening of subjects will occur within 28 days prior to the first dosing. Subjects will be housed on Day -1, at the time indicated by the CRU, until completion of study procedures on Day 2 of each period. On Day 1 of each period, subjects will receive 1 of 4 treatments: a single therapeutic dose of epetraborole (Treatment A), a single supratherapeutic dose of epetraborole (Treatment B), a single dose of epetraborole matching-placebo (Treatment C), or a single dose of moxifloxacin (Treatment D). Cardiodynamic ECGs and PK blood samples for epetraborole, metabolite M3, and moxifloxacin (as applicable) will be collected predose and for 24 hours postdose in each period. There will be a washout of at least 10 days between doses. Safety will be monitored throughout the study by repeated clinical and laboratory evaluations, including a follow-up visit approximately 14 days after the last dose.
  primary purpose: Basic Science
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Changes to QTc interval
  time frame: Study Day -1 to Study Day 2
  description: Effect of epetraborole plasma concentrations on the QTc interval using linear mixed effect exposure-response modeling, including the predicted ddQTc at Cmax values corresponding to exposure levels of interest.
  measure: Effect of epetraborole plasma concentrations on other ECG parameters on QTc
  time frame: Study Day -1 to Study Day 2
  description: Measure the Effect of epetraborole plasma concentrations on other ECG parameters on QTc
  measure: Assay sensitivity
  time frame: Study Day -1 to Study Day 2
  description: Assay sensitivity assessment with ddQTc at the geometric mean Cmax value predicted from a linear mixed effect model evaluating the relationship between QTc and moxifloxacin plasma concentrations (exposure-response modeling).
  measure: Analysis of dQTc
  time frame: Study Day -1 to Study Day 2
  description: QTc interval using a mixed effect analysis of covariance (ANCOVA) carried out as appropriate to analyze dQTc at each time point post baseline.
  measure: PK Concentration analysis for epetraborole and metabolite M3 of AUC0 t
  time frame: Study Day -1 to Study Day 2
  description: Analysis of PK Concentration for epetraborole and metabolite M3 of AUC0 t
  measure: Evaluation of TEAEs
  time frame: Study Day 1 through Study Day 14
  description: TEAEs
  measure: Safety Vital Signs changes of body temperature
  time frame: Study Day 1 through Study Day 14
  description: Measure Safety Vital Signs changes of body temperature
  measure: Orthostatic Vital Signs changes of Heart Rate from supine to standing position.
  time frame: Study Day 1 through Study Day 14
  description: Measure Orthostatic Vital Signs changes of Heart Rate from supine to standing position.
  measure: Effect of epetraborole plasma concentrations on other ECG parameters on, PR
  time frame: Study Day -1 to Study Day 2
  description: Measure the Effect of epetraborole plasma concentrations on other ECG parameters on, PR
  measure: Effect of epetraborole plasma concentrations on other ECG parameters on QRS duration
  time frame: Study Day -1 to Study Day 2
  description: Measure the Effect of epetraborole plasma concentrations on other ECG parameters on QRS duration.
  measure: Effect of epetraborole plasma concentrations on other ECG parameters on HR.
  time frame: Study Day -1 to Study Day 2
  description: Measure the Effect of epetraborole plasma concentrations on other ECG parameters on HR.
  measure: PK Concentration analysis for epetraborole and metabolite M3 of AUC0 inf
  time frame: Study Day -1 to Study Day 2
  description: Analysis of PK Concentration for epetraborole and metabolite M3 of AUC0 inf
  measure: PK Concentration analysis for epetraborole and metabolite M3 of AUC%extrap
  time frame: Study Day -1 to Study Day 2
  description: Analysis of PK Concentration for epetraborole and metabolite M3 of AUC%extrap
  measure: PK Concentration analysis for epetraborole and metabolite M3 of Cmax
  time frame: Study Day -1 to Study Day 2
  description: Analysis of PK Concentration for epetraborole and metabolite M3 of Cmax
  measure: PK Concentration analysis for epetraborole and metabolite M3 of Tmax
  time frame: Study Day -1 to Study Day 2
  description: Analysis of PK Concentration for epetraborole and metabolite M3 of Tmax
  measure: PK Concentration analysis for epetraborole and metabolite M3 of Kel
  time frame: Study Day -1 to Study Day 2
  description: Analysis of PK Concentration for epetraborole and metabolite M3 of Kel
  measure: PK Concentration analysis for epetraborole and metabolite M3 of t½
  time frame: Study Day -1 to Study Day 2
  description: Analysis of PK Concentration for epetraborole and metabolite M3 of t½
  measure: PK Concentration analysis for epetraborole and metabolite M3 of CL/F (parent only),
  time frame: Study Day -1 to Study Day 2
  description: Analysis of PK Concentration for epetraborole and metabolite M3 of CL/F (parent only),
  measure: PK Concentration analysis for epetraborole and metabolite M3 of Vz/F (parent only)
  time frame: Study Day -1 to Study Day 2
  description: Analysis of PK Concentration for epetraborole and metabolite M3 of Vz/F (parent only
  measure: PK Concentration analysis for epetraborole and metabolite M3 of MR AUC0 t
  time frame: Study Day -1 to Study Day 2
  description: Analysis of PK Concentration for epetraborole and metabolite M3 of MR AUC0 t
  measure: PK Concentration analysis for epetraborole and metabolite M3 of MR AUC0 inf
  time frame: Study Day -1 to Study Day 2
  description: Analysis of PK Concentration for epetraborole and metabolite M3 of MR AUC0 inf
  measure: PK Concentration analysis for epetraborole and metabolite M3 of MR Cmax
  time frame: Study Day -1 to Study Day 2
  description: Analysis of PK Concentration for epetraborole and metabolite M3 of MR Cmax
  measure: Safety Vital Signs changes of respiratory rate
  time frame: Study Day 1 through Study Day 14
  description: Measure Safety Vital Signs changes of respiratory rate
  measure: Safety Vital Signs changes of blood pressure
  time frame: Study Day 1 through Study Day 14
  description: Measure Safety Vital Signs changes of blood pressure (systolic and diastolic)
  measure: Safety Vital Signs changes of heart rate
  time frame: Study Day 1 through Study Day 14
  description: measure Safety Vital Signs changes of heart rate
  measure: Orthostatic Vital Signs changes of blood pressure from supine to standing position.
  time frame: Study Day 1 through Study Day 14
  description: Measure Orthostatic Vital Signs changes of blood pressure from supine to standing position (systolic and diastolic).
  arm group label: 500 mg epetraborole
  arm group type: Experimental
  description: 500 mg epetraborole
  arm group label: 2000 mg epetraborole
  arm group type: Experimental
  description: 2000 mg epetraborole
  arm group label: Epetraborole-matching placebo
  arm group type: Placebo Comparator
  description: Epetraborole-matching placebo
  arm group label: 400 mg moxifloxacin
  arm group type: Active Comparator
  description: 400 mg moxifloxacin
  intervention type: Drug
  intervention name: Epetraborole and matching placebo
  description: Treatment A (Therapeutic): 500 mg epetraborole (2 x 250 mg tablets) and epetraborole matching-placebo (6 tablets)
  arm group label: Epetraborole-matching placebo
  other name: Therapeutic
  intervention type: Drug
  intervention name: Epetraborole
  description: Treatment B (Supratherapeutic): 2000 mg epetraborole (8 x 250 mg tablets)
  arm group label: 2000 mg epetraborole
  arm group label: 500 mg epetraborole
  other name: Supratherapeutic
  intervention type: Drug
  intervention name: Placebo
  description: Treatment C (Placebo control): Epetraborole matching-placebo (8 tablets)
  arm group label: Epetraborole-matching placebo
  other name: Placebo Control
  intervention type: Drug
  intervention name: Moxifloxacin
  description: Treatment D (Positive control): 400 mg moxifloxacin (1 x 400 mg tablet)
  arm group label: 400 mg moxifloxacin
  other name: Positive Control
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: United States
  responsible party type: Sponsor
  mesh term: Moxifloxacin