<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/NCT02234570</url>
  </required_header>
  <id_info>
    <org_study_id>12-0053</org_study_id>
    <nct_id>NCT02234570</nct_id>
  </id_info>
  <brief_title>Phase I Trial Evaluating the Safety and Pharmacokinetics of Oxfendazole</brief_title>
  <official_title>A Randomized, Double-Blind Placebo-Controlled Phase I Trial Evaluating the Safety and Pharmacokinetics of Oxfendazole</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Institute of Allergy and Infectious Diseases (NIAID)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Institute of Allergy and Infectious Diseases (NIAID)</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objectives of the Phase I study are to evaluate the safety and tolerance of increasing&#xD;
      single oral doses of oxfendazole in healthy volunteers.The secondary objectives assess the&#xD;
      pharmacokinetic profile of oxfendazole and assess the metabolism of oxfendazole. The&#xD;
      description of agent used is single oral dose of an aqueous suspension of oxfendazole, a&#xD;
      benzimidazole carbamate antiparasitic drug. Each new cohort will be dosed only after the two&#xD;
      week safety data for the preceding group have been reviewed. If a clinically significant AE&#xD;
      is observed, and if this event is drug-related the safety monitoring committee will be&#xD;
      convened to determine whether the study should continue.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This Phase I study is a randomized, double-blind, placebo-controlled evaluation of the safety&#xD;
      and pharmacokinetics of escalating single oral doses of oxfendazole (0.5 to 60 mg/kg) in&#xD;
      healthy volunteers. Up to 70 healthy males and females (non-chldbearing potential), ages&#xD;
      18-45 volunteers recruited from one site will participate in this study. The study duration&#xD;
      is approximately 18 months with subject participation of 2 weeks. The primary objective&#xD;
      assess the safety and tolerability of oxfendazole in healthy adults. The secondary objectives&#xD;
      assess the pharmacokinetic profile of oxfendazole and assess the metabolism of oxfendazole.&#xD;
      Two sentinel subjects will receive the study product (1 drug/1 placebo) in each group and be&#xD;
      monitored 48 hours for adverse events prior to completing enrollment of the remaining 8&#xD;
      subjects in the group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 17, 2014</start_date>
  <completion_date type="Actual">November 24, 2015</completion_date>
  <primary_completion_date type="Actual">November 24, 2015</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 (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Subjects Reporting Adverse Events Related to Oxfendazole Within 14 Days of Receipt of a Single Oral Dose.</measure>
    <time_frame>Within 14 Days of first dose</time_frame>
    <description>All adverse events, defined as any untoward medical occurrence regardless of its causal relationship to the study treatment, were collected for 14 days after dosing. The PI then determined relatedness to the study drug. Related was defined as &quot;there is a reasonable possibility that the study product caused the adverse event. Reasonable possibility means that there is evidence to suggest a causal relationship between the study product and the adverse event.&quot;</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Area Under the Concentration Time-curve From Time Zero to Infinity (AUC(0-infinity)) for Oxfendazole</measure>
    <time_frame>0, 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 336 hours post-dose</time_frame>
    <description>AUC(0-infinity) was defined as the total area under the concentration-time curve from dosing (time 0) taken to the limit as the end time becomes arbitrarily large. AUC(0-infinity) and was calculated by adding AUC(0-last) to an extrapolated value equal to the last measured concentration greater than the lower limit of quantification of the bioanalytical assay divided by the terminal phase elimination rate constant (Ke) computed from concentrations that were measured using a validated HPLCMS/MS method</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Observed Concentration (Cmax) of Oxfendazole in Plasma</measure>
    <time_frame>0, 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 336 hours post-dose</time_frame>
    <description>Cmax is defined as the maximum observed drug concentration observed in plasma over all PK sample concentrations computed from concentrations that were measured using a validated HPLC-MS/MS method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma Concentrations of Oxfendazole Fenbendazole</measure>
    <time_frame>Day 1-Day15</time_frame>
    <description>Concentrations of oxfendazole fenbendazole in plasma were measured using a validated HPLCMS/MS method. Concentrations &lt;LLOQ (2 ng/mL) set to LLOQ/2 if after 1st =LLOQ concentration or 0 otherwise for calculating summary statistics.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma Concentrations of Oxfendazole Sulfone</measure>
    <time_frame>Day 1-Day15</time_frame>
    <description>Concentrations of oxfendazole sulfone in plasma were measured using a validated HPLCMS/MS method. Concentrations &lt;LLOQ (2 ng/mL) set to LLOQ/2 if after 1st =LLOQ concentration or 0 otherwise for calculating summary statistics.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal Elimination Half-life (t1/2) of Oxfendazole</measure>
    <time_frame>0, 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 336 hours post-dose</time_frame>
    <description>The apparent terminal elimination half-life (t1/2) was defined as the time required for the drug concentration to decrease by a factor of one-half in the terminal phase computed from concentrations that were measured using a validated HPLCMS/MS method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time of Maximum Observed Concentration (Tmax) of Oxfendazole</measure>
    <time_frame>0, 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 336 hours post-dose</time_frame>
    <description>Tmax was defined as the time at which the maximum concentration (Cmax) occurs in plasma computed from concentrations that were measured using a validated HPLCMS/MS method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urine Concentrations of Oxfendazole Fenbendazole</measure>
    <time_frame>Day 1-Day 15</time_frame>
    <description>Concentrations of oxfendazole fenbendazole in urine were measured using a validated HPLCMS/MS method. Concentrations &lt;LLOQ (2 ng/mL) set to LLOQ/2 if after 1st =LLOQ concentration or 0 otherwise for calculating summary statistics.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urine Concentrations of Oxfendazole Sulfone</measure>
    <time_frame>Day 1-Day 15</time_frame>
    <description>Concentrations of oxfendazole sulfone in urine were measured using a validated HPLCMS/MS method. Concentrations &lt;LLOQ (2 ng/mL) set to LLOQ/2 if after 1st =LLOQ concentration or 0 otherwise for calculating summary statistics.</description>
  </secondary_outcome>
  <number_of_arms>7</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Neurocysticercosis</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>N=8 subjects receive single oral dose 0.5mg/kg of oxfendazole; N= 2 subjects receive single oral dose placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>N=8 subjects receive single oral dose 1mg/kg of oxfendazole; N=2 subjects receive single oral dose placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>N=8 subjects receive single oral dose 3mg/kg of oxfendazole; N= 2 subjects receive single oral dose placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>N=8 subjects receive single oral dose 7.5mg/kg of oxfendazole; N=2 subjects receive single oral dose placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 5</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>N=8 subjects receive single oral dose 15mg/kg of oxfendazole; N= 2 subjects receive single oral dose placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 6</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>N=8 subjects receive single oral dose 30mg/kg of oxfendazole; N=2 subjects receive single oral dose placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 7</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>N=8 subjects receive single oral dose 60mg/kg of oxfendazole; N=2 subjects receive single oral dose placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxfendazole</intervention_name>
    <description>A benzimidazole carbamate antiparasitic drug. Oral Dose levels of 0.5,1, 3, 7.5, 15, 30, and 60 mg/kg will be evaluated sequentially, the dose increasing with each new cohort Group 1 to Group 7.</description>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_label>Group 3</arm_group_label>
    <arm_group_label>Group 4</arm_group_label>
    <arm_group_label>Group 5</arm_group_label>
    <arm_group_label>Group 6</arm_group_label>
    <arm_group_label>Group 7</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Normal Saline administered with an oral dosing syringe. Group 1- Group 6</description>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_label>Group 3</arm_group_label>
    <arm_group_label>Group 4</arm_group_label>
    <arm_group_label>Group 5</arm_group_label>
    <arm_group_label>Group 6</arm_group_label>
    <arm_group_label>Group 7</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        1. Males and females of non-childbearing potential between the ages of 18 and 45 years,&#xD;
        inclusive.* *Surgically sterile via tubal ligation, bilateral oophorectomy or hysterectomy&#xD;
        or who have been postmenopausal for &gt;/=1 year confirmed by LH and FSH levels. 2. In good&#xD;
        health, as judged by the investigator and determined by vital signs* Temperature &lt; 38&#xD;
        degrees Celsius, heart rate &lt;/=100 bpm and &gt; 50 bpm, systolic blood pressure &lt;/= 140 mmHg&#xD;
        and &gt; 89 mmHg, diastolic blood pressure &lt;/=90 mmHg and &gt;/= 60 mm Hg, medical history and a&#xD;
        targeted physical examination. BMI &gt;/=18 and &lt;/= 35. Athletically trained subjects with a&#xD;
        pulse &gt;/= 45 may be enrolled at the discretion of the principal investigator or designated&#xD;
        licensed clinical investigator. 3. Acceptable screening laboratories* *Hemoglobin, white&#xD;
        blood cell (WBC) count, neutrophil, eosinophil and platelet counts within normal ranges.&#xD;
        AST &lt; 44 and ALT &lt; 44 and total bilirubin, creatinine must be equal to or below the upper&#xD;
        limit of normal (for eosinophil count, AST, ALT, creatinine, and total bilirubin values&#xD;
        below the normal range are acceptable). Random blood glucose must be &lt;140. Urine dipstick&#xD;
        testing must be negative for glucose and negative or trace for protein. The following&#xD;
        serology tests must be negative: HIV 1/2 antibody, hepatitis B surface antigen (HBsAg), and&#xD;
        hepatitis C virus (HCV) antibody. HIV and hepatitis C viral load PCR testing may be&#xD;
        performed for individuals suspected of having indeterminate antibody testing. 4. Male&#xD;
        participants must be willing to ensure use of condoms and spermicides for 4 months after&#xD;
        study drug administration. 5. Provide written informed consent before initiation of any&#xD;
        study procedures. 6. Willing to be available for all study-required procedures, and visits&#xD;
        for the duration of the study. 7. Able to provide a home phone number, and the name,&#xD;
        address, and/or email of a person willing to assist with making contact during the&#xD;
        follow-up phase of the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1. History of residing for 6 or more months in regions with endemic cysticercosis as&#xD;
        determined by the principal investigator or a designated study physician. 2. Breastfeeding&#xD;
        females. 3. Body temperature &gt;/=100.4 degrees Fahrenheit (&gt;/=38.0 degrees Celsius) or acute&#xD;
        illness within 3 days before administration of study drug (subject may be rescheduled). 4.&#xD;
        Chronic or acute medical disorder* *Disorders of the cardiac, pulmonary, liver, kidney,&#xD;
        neurologic, gastrointestinal or other system, such that in the opinion of the investigator&#xD;
        participation in the study creates additional risk to the subject, or to the validity of&#xD;
        the study. 5. Use of chronic systemic medications* *Intermittent use of over the counter&#xD;
        medications such as acetaminophen, ibuprofen, cold and sinus medications are permitted for&#xD;
        enrollment (please see section 5.6 for instructions on medication use during the&#xD;
        study).Topical medications, nasal steroids are permitted throughout the study. Use of the&#xD;
        prescription medications used less than once per week on average are permitted for&#xD;
        enrollment (see section 5.6 for instructions on medication use during the study). If the&#xD;
        subject has taken a short term prescription medication within the past 30 days (e.g. an&#xD;
        antibiotic), they should be postponed from enrollment until 30 days have elapsed since the&#xD;
        last dose 6. Has history of sensitivity to related benzimidazole compounds (e.g.,&#xD;
        albendazole, mebendazole). 7. A diagnosis of schizophrenia, bipolar disease, or history of&#xD;
        hospitalization for a psychiatric condition or previous suicide attempt. 8. A history of&#xD;
        treatment for any other psychiatric disorder in the past 3 years.* *Past treatment for ADHD&#xD;
        does not exclude participants from enrollment as long as the medications have been&#xD;
        discontinued for a minimum of 3 months and symptoms are well controlled. 9. Received an&#xD;
        experimental agent* within 1 month before administration of study drug or expect to receive&#xD;
        an experimental agent during the 15-day study period. *Vaccine, drug, biologic, device,&#xD;
        blood product, or medication. 10. Any condition that would, in the opinion of the&#xD;
        investigator, place them at an unacceptable risk of injury, render them unable to meet the&#xD;
        requirements of the protocol, or that may interfere with successful completion of the&#xD;
        study. 11. A history of alcohol consumption* or any illicit drug use†, or history of&#xD;
        substance abuse#. Individuals must agree to abstain from drug or alcohol use for 48 hours&#xD;
        prior to enrollment through day 15. *Greater than 7 alcoholic drinks per week. †Other than&#xD;
        occasional marijuana use (less than once per week for the past 60 days is acceptable).&#xD;
        #Alcohol or illicit drugs within the past 3 years. 12. History of chronic tobacco use in&#xD;
        the past 60 days.* *A history of occasional tobacco use (less than 1 pack per week on&#xD;
        average) is acceptable. Individuals will be counseled to abstain from use of tobacco and&#xD;
        marijuana from screening through day 15.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Iowa - Vaccine Research and Education Unit</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242-2600</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 5, 2019</verification_date>
  <study_first_submitted>August 28, 2014</study_first_submitted>
  <study_first_submitted_qc>September 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 9, 2014</study_first_posted>
  <results_first_submitted>November 7, 2019</results_first_submitted>
  <results_first_submitted_qc>November 7, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">November 26, 2019</results_first_posted>
  <last_update_submitted>October 29, 2020</last_update_submitted>
  <last_update_submitted_qc>October 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>neurocysticercosis</keyword>
  <keyword>pork tapeworm</keyword>
  <keyword>Taenia solium</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neurocysticercosis</mesh_term>
    <mesh_term>Cysticercosis</mesh_term>
    <mesh_term>Taeniasis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Oxfendazole</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 1, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/70/NCT02234570/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 15, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/70/NCT02234570/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were healthy adult males and non-pregnant females recruited from existing volunteer populations and from the communities at large around the clinical site. Participants were enrolled between 17NOV2014 and 09NOV2015.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>0.5 mg/kg Oxfendazole</title>
          <description>Participants received a single oral dose 0.5 mg/kg of oxfendazole.</description>
        </group>
        <group group_id="P2">
          <title>1 mg/kg Oxfendazole</title>
          <description>Participants received a single oral dose 1 mg/kg of oxfendazole</description>
        </group>
        <group group_id="P3">
          <title>3 mg/kg Oxfendazole</title>
          <description>Participants received a single oral dose 3 mg/kg of oxfendazole</description>
        </group>
        <group group_id="P4">
          <title>7.5 mg/kg Oxfendazole</title>
          <description>Participants received a single oral dose 7.5 mg/kg of oxfendazole</description>
        </group>
        <group group_id="P5">
          <title>15 mg/kg Oxfendazole</title>
          <description>Participants received a single oral dose 15 mg/kg of oxfendazole</description>
        </group>
        <group group_id="P6">
          <title>30 mg/kg Oxfendazole</title>
          <description>Participants received a single oral dose 30 mg/kg of oxfendazole</description>
        </group>
        <group group_id="P7">
          <title>60 mg/kg Oxfendazole</title>
          <description>Participants received a single oral dose 60 mg/kg of oxfendazole</description>
        </group>
        <group group_id="P8">
          <title>Placebo</title>
          <description>Participants received a single placebo formulation consisting of 4.5% polyethylene glycol, 0.18% methyl paraben, and 95.32% sterile water for injection</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="8"/>
                <participants group_id="P4" count="8"/>
                <participants group_id="P5" count="8"/>
                <participants group_id="P6" count="8"/>
                <participants group_id="P7" count="8"/>
                <participants group_id="P8" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="8"/>
                <participants group_id="P4" count="8"/>
                <participants group_id="P5" count="8"/>
                <participants group_id="P6" count="8"/>
                <participants group_id="P7" count="8"/>
                <participants group_id="P8" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All participants are included in the analysis population.</population>
      <group_list>
        <group group_id="B1">
          <title>0.5 mg/kg Oxfendazole</title>
          <description>Participants received a single oral dose 0.5 mg/kg of oxfendazole.</description>
        </group>
        <group group_id="B2">
          <title>1 mg/kg Oxfendazole</title>
          <description>Participants received a single oral dose 1 mg/kg of oxfendazole</description>
        </group>
        <group group_id="B3">
          <title>3 mg/kg Oxfendazole</title>
          <description>Participants received a single oral dose 3 mg/kg of oxfendazole</description>
        </group>
        <group group_id="B4">
          <title>7.5 mg/kg Oxfendazole</title>
          <description>Participants received a single oral dose 7.5 mg/kg of oxfendazole</description>
        </group>
        <group group_id="B5">
          <title>15 mg/kg Oxfendazole</title>
          <description>Participants received a single oral dose 15 mg/kg of oxfendazole</description>
        </group>
        <group group_id="B6">
          <title>30 mg/kg Oxfendazole</title>
          <description>Participants received a single oral dose 30 mg/kg of oxfendazole</description>
        </group>
        <group group_id="B7">
          <title>60 mg/kg Oxfendazole</title>
          <description>Participants received a single oral dose 60 mg/kg of oxfendazole</description>
        </group>
        <group group_id="B8">
          <title>Placebo</title>
          <description>Participants received a single placebo formulation consisting of 4.5% polyethylene glycol, 0.18% methyl paraben, and 95.32% sterile water for injection</description>
        </group>
        <group group_id="B9">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="8"/>
            <count group_id="B2" value="8"/>
            <count group_id="B3" value="8"/>
            <count group_id="B4" value="8"/>
            <count group_id="B5" value="8"/>
            <count group_id="B6" value="8"/>
            <count group_id="B7" value="8"/>
            <count group_id="B8" value="14"/>
            <count group_id="B9" value="70"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="8"/>
                    <measurement group_id="B6" value="8"/>
                    <measurement group_id="B7" value="8"/>
                    <measurement group_id="B8" value="14"/>
                    <measurement group_id="B9" value="70"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26.8" spread="6.7"/>
                    <measurement group_id="B2" value="26.6" spread="6.8"/>
                    <measurement group_id="B3" value="23.8" spread="6.1"/>
                    <measurement group_id="B4" value="26.3" spread="7.1"/>
                    <measurement group_id="B5" value="26.8" spread="9.3"/>
                    <measurement group_id="B6" value="22.6" spread="6.7"/>
                    <measurement group_id="B7" value="24.6" spread="8.0"/>
                    <measurement group_id="B8" value="26.9" spread="7.2"/>
                    <measurement group_id="B9" value="25.6" spread="7.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="1"/>
                    <measurement group_id="B9" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="8"/>
                    <measurement group_id="B6" value="8"/>
                    <measurement group_id="B7" value="8"/>
                    <measurement group_id="B8" value="13"/>
                    <measurement group_id="B9" value="67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="2"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="6"/>
                    <measurement group_id="B6" value="7"/>
                    <measurement group_id="B7" value="6"/>
                    <measurement group_id="B8" value="14"/>
                    <measurement group_id="B9" value="61"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="5"/>
                    <measurement group_id="B6" value="6"/>
                    <measurement group_id="B7" value="6"/>
                    <measurement group_id="B8" value="12"/>
                    <measurement group_id="B9" value="57"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="2"/>
                    <measurement group_id="B9" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="8"/>
                    <measurement group_id="B6" value="8"/>
                    <measurement group_id="B7" value="8"/>
                    <measurement group_id="B8" value="14"/>
                    <measurement group_id="B9" value="70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Subjects Reporting Adverse Events Related to Oxfendazole Within 14 Days of Receipt of a Single Oral Dose.</title>
        <description>All adverse events, defined as any untoward medical occurrence regardless of its causal relationship to the study treatment, were collected for 14 days after dosing. The PI then determined relatedness to the study drug. Related was defined as &quot;there is a reasonable possibility that the study product caused the adverse event. Reasonable possibility means that there is evidence to suggest a causal relationship between the study product and the adverse event.&quot;</description>
        <time_frame>Within 14 Days of first dose</time_frame>
        <population>All participants are included in the analysis population.</population>
        <group_list>
          <group group_id="O1">
            <title>0.5 mg/kg Oxfendazole</title>
            <description>Participants received a single oral dose 0.5 mg/kg of oxfendazole.</description>
          </group>
          <group group_id="O2">
            <title>1 mg/kg Oxfendazole</title>
            <description>Participants received a single oral dose 1 mg/kg of oxfendazole</description>
          </group>
          <group group_id="O3">
            <title>3 mg/kg Oxfendazole</title>
            <description>Participants received a single oral dose 3 mg/kg of oxfendazole</description>
          </group>
          <group group_id="O4">
            <title>7.5 mg/kg Oxfendazole</title>
            <description>Participants received a single oral dose 7.5 mg/kg of oxfendazole</description>
          </group>
          <group group_id="O5">
            <title>15 mg/kg Oxfendazole</title>
            <description>Participants received a single oral dose 15 mg/kg of oxfendazole</description>
          </group>
          <group group_id="O6">
            <title>30 mg/kg Oxfendazole</title>
            <description>Participants received a single oral dose 30 mg/kg of oxfendazole</description>
          </group>
          <group group_id="O7">
            <title>60 mg/kg Oxfendazole</title>
            <description>Participants received a single oral dose 60 mg/kg of oxfendazole</description>
          </group>
          <group group_id="O8">
            <title>Placebo</title>
            <description>Participants received a single placebo formulation consisting of 4.5% polyethylene glycol, 0.18% methyl paraben, and 95.32% sterile water for injection</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Reporting Adverse Events Related to Oxfendazole Within 14 Days of Receipt of a Single Oral Dose.</title>
          <description>All adverse events, defined as any untoward medical occurrence regardless of its causal relationship to the study treatment, were collected for 14 days after dosing. The PI then determined relatedness to the study drug. Related was defined as &quot;there is a reasonable possibility that the study product caused the adverse event. Reasonable possibility means that there is evidence to suggest a causal relationship between the study product and the adverse event.&quot;</description>
          <population>All participants are included in the analysis population.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="8"/>
                <count group_id="O5" value="8"/>
                <count group_id="O6" value="8"/>
                <count group_id="O7" value="8"/>
                <count group_id="O8" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Area Under the Concentration Time-curve From Time Zero to Infinity (AUC(0-infinity)) for Oxfendazole</title>
        <description>AUC(0-infinity) was defined as the total area under the concentration-time curve from dosing (time 0) taken to the limit as the end time becomes arbitrarily large. AUC(0-infinity) and was calculated by adding AUC(0-last) to an extrapolated value equal to the last measured concentration greater than the lower limit of quantification of the bioanalytical assay divided by the terminal phase elimination rate constant (Ke) computed from concentrations that were measured using a validated HPLCMS/MS method</description>
        <time_frame>0, 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 336 hours post-dose</time_frame>
        <population>All participants receiving oxfendazole are included in the analysis population.</population>
        <group_list>
          <group group_id="O1">
            <title>0.5 mg/kg Oxfendazole</title>
            <description>Participants received a single oral dose 0.5 mg/kg of oxfendazole.</description>
          </group>
          <group group_id="O2">
            <title>1 mg/kg Oxfendazole</title>
            <description>Participants received a single oral dose 1 mg/kg of oxfendazole</description>
          </group>
          <group group_id="O3">
            <title>3 mg/kg Oxfendazole</title>
            <description>Participants received a single oral dose 3 mg/kg of oxfendazole</description>
          </group>
          <group group_id="O4">
            <title>7.5 mg/kg Oxfendazole</title>
            <description>Participants received a single oral dose 7.5 mg/kg of oxfendazole</description>
          </group>
          <group group_id="O5">
            <title>15 mg/kg Oxfendazole</title>
            <description>Participants received a single oral dose 15 mg/kg of oxfendazole</description>
          </group>
          <group group_id="O6">
            <title>30 mg/kg Oxfendazole</title>
            <description>Participants received a single oral dose 30 mg/kg of oxfendazole</description>
          </group>
          <group group_id="O7">
            <title>60 mg/kg Oxfendazole</title>
            <description>Participants received a single oral dose 60 mg/kg of oxfendazole</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Concentration Time-curve From Time Zero to Infinity (AUC(0-infinity)) for Oxfendazole</title>
          <description>AUC(0-infinity) was defined as the total area under the concentration-time curve from dosing (time 0) taken to the limit as the end time becomes arbitrarily large. AUC(0-infinity) and was calculated by adding AUC(0-last) to an extrapolated value equal to the last measured concentration greater than the lower limit of quantification of the bioanalytical assay divided by the terminal phase elimination rate constant (Ke) computed from concentrations that were measured using a validated HPLCMS/MS method</description>
          <population>All participants receiving oxfendazole are included in the analysis population.</population>
          <units>ng•hr/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="8"/>
                <count group_id="O5" value="8"/>
                <count group_id="O6" value="8"/>
                <count group_id="O7" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11682.4" spread="44.8"/>
                    <measurement group_id="O2" value="13117.7" spread="54.4"/>
                    <measurement group_id="O3" value="30803.1" spread="20.1"/>
                    <measurement group_id="O4" value="73928.9" spread="40.6"/>
                    <measurement group_id="O5" value="99542.6" spread="23.9"/>
                    <measurement group_id="O6" value="78344.0" spread="34.4"/>
                    <measurement group_id="O7" value="108618.2" spread="38.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Maximum Observed Concentration (Cmax) of Oxfendazole in Plasma</title>
        <description>Cmax is defined as the maximum observed drug concentration observed in plasma over all PK sample concentrations computed from concentrations that were measured using a validated HPLC-MS/MS method.</description>
        <time_frame>0, 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 336 hours post-dose</time_frame>
        <population>All participants receiving oxfendazole are included in the analysis population.</population>
        <group_list>
          <group group_id="O1">
            <title>0.5 mg/kg Oxfendazole</title>
            <description>Participants received a single oral dose 0.5 mg/kg of oxfendazole.</description>
          </group>
          <group group_id="O2">
            <title>1 mg/kg Oxfendazole</title>
            <description>Participants received a single oral dose 1 mg/kg of oxfendazole</description>
          </group>
          <group group_id="O3">
            <title>3 mg/kg Oxfendazole</title>
            <description>Participants received a single oral dose 3 mg/kg of oxfendazole</description>
          </group>
          <group group_id="O4">
            <title>7.5 mg/kg Oxfendazole</title>
            <description>Participants received a single oral dose 7.5 mg/kg of oxfendazole</description>
          </group>
          <group group_id="O5">
            <title>15 mg/kg Oxfendazole</title>
            <description>Participants received a single oral dose 15 mg/kg of oxfendazole</description>
          </group>
          <group group_id="O6">
            <title>30 mg/kg Oxfendazole</title>
            <description>Participants received a single oral dose 30 mg/kg of oxfendazole</description>
          </group>
          <group group_id="O7">
            <title>60 mg/kg Oxfendazole</title>
            <description>Participants received a single oral dose 60 mg/kg of oxfendazole</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Observed Concentration (Cmax) of Oxfendazole in Plasma</title>
          <description>Cmax is defined as the maximum observed drug concentration observed in plasma over all PK sample concentrations computed from concentrations that were measured using a validated HPLC-MS/MS method.</description>
          <population>All participants receiving oxfendazole are included in the analysis population.</population>
          <units>ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="8"/>
                <count group_id="O5" value="8"/>
                <count group_id="O6" value="8"/>
                <count group_id="O7" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="943.9" spread="28.4"/>
                    <measurement group_id="O2" value="1155.9" spread="26.8"/>
                    <measurement group_id="O3" value="2436.9" spread="24.0"/>
                    <measurement group_id="O4" value="4781.3" spread="25.6"/>
                    <measurement group_id="O5" value="6254.8" spread="21.7"/>
                    <measurement group_id="O6" value="5301.3" spread="30.5"/>
                    <measurement group_id="O7" value="6768.4" spread="31.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Plasma Concentrations of Oxfendazole Fenbendazole</title>
        <description>Concentrations of oxfendazole fenbendazole in plasma were measured using a validated HPLCMS/MS method. Concentrations &lt;LLOQ (2 ng/mL) set to LLOQ/2 if after 1st =LLOQ concentration or 0 otherwise for calculating summary statistics.</description>
        <time_frame>Day 1-Day15</time_frame>
        <population>All participants receiving oxfendazole are included in the analysis population</population>
        <group_list>
          <group group_id="O1">
            <title>0.5 mg/kg Oxfendazole</title>
            <description>Participants received a single oral dose 0.5 mg/kg of oxfendazole.</description>
          </group>
          <group group_id="O2">
            <title>1 mg/kg Oxfendazole</title>
            <description>Participants received a single oral dose 1 mg/kg of oxfendazole</description>
          </group>
          <group group_id="O3">
            <title>3 mg/kg Oxfendazole</title>
            <description>Participants received a single oral dose 3 mg/kg of oxfendazole</description>
          </group>
          <group group_id="O4">
            <title>7.5 mg/kg Oxfendazole</title>
            <description>Participants received a single oral dose 7.5 mg/kg of oxfendazole</description>
          </group>
          <group group_id="O5">
            <title>15 mg/kg Oxfendazole</title>
            <description>Participants received a single oral dose 15 mg/kg of oxfendazole</description>
          </group>
          <group group_id="O6">
            <title>30 mg/kg Oxfendazole</title>
            <description>Participants received a single oral dose 30 mg/kg of oxfendazole</description>
          </group>
          <group group_id="O7">
            <title>60 mg/kg Oxfendazole</title>
            <description>Participants received a single oral dose 60 mg/kg of oxfendazole</description>
          </group>
        </group_list>
        <measure>
          <title>Plasma Concentrations of Oxfendazole Fenbendazole</title>
          <description>Concentrations of oxfendazole fenbendazole in plasma were measured using a validated HPLCMS/MS method. Concentrations &lt;LLOQ (2 ng/mL) set to LLOQ/2 if after 1st =LLOQ concentration or 0 otherwise for calculating summary statistics.</description>
          <population>All participants receiving oxfendazole are included in the analysis population</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="8"/>
                <count group_id="O5" value="8"/>
                <count group_id="O6" value="8"/>
                <count group_id="O7" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>1 Hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="0"/>
                    <measurement group_id="O2" value="0" spread="0"/>
                    <measurement group_id="O3" value="0.3" spread="0.8"/>
                    <measurement group_id="O4" value="0.3" spread="0.7"/>
                    <measurement group_id="O5" value="1.0" spread="1.4"/>
                    <measurement group_id="O6" value="1.4" spread="1.2"/>
                    <measurement group_id="O7" value="5.9" spread="2.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 Hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="0"/>
                    <measurement group_id="O2" value="0" spread="0"/>
                    <measurement group_id="O3" value="0.4" spread="0.8"/>
                    <measurement group_id="O4" value="1.1" spread="1.5"/>
                    <measurement group_id="O5" value="2.6" spread="2.5"/>
                    <measurement group_id="O6" value="2.2" spread="1.5"/>
                    <measurement group_id="O7" value="6.3" spread="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 Hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6" spread="1.8"/>
                    <measurement group_id="O2" value="0.8" spread="1.1"/>
                    <measurement group_id="O3" value="3.5" spread="2.5"/>
                    <measurement group_id="O4" value="3.0" spread="3.2"/>
                    <measurement group_id="O5" value="8.1" spread="8.0"/>
                    <measurement group_id="O6" value="4.4" spread="4.3"/>
                    <measurement group_id="O7" value="8.0" spread="3.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5" spread="1.3"/>
                    <measurement group_id="O2" value="2.0" spread="1.4"/>
                    <measurement group_id="O3" value="4.8" spread="2.9"/>
                    <measurement group_id="O4" value="6.6" spread="4.8"/>
                    <measurement group_id="O5" value="9.9" spread="8.3"/>
                    <measurement group_id="O6" value="5.8" spread="6.7"/>
                    <measurement group_id="O7" value="12.4" spread="4.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8 Hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3" spread="0.9"/>
                    <measurement group_id="O2" value="1.9" spread="1.2"/>
                    <measurement group_id="O3" value="5.2" spread="2.9"/>
                    <measurement group_id="O4" value="6.7" spread="4.6"/>
                    <measurement group_id="O5" value="10.8" spread="8.3"/>
                    <measurement group_id="O6" value="5.0" spread="5.1"/>
                    <measurement group_id="O7" value="15.5" spread="8.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>10 Hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3" spread="0.8"/>
                    <measurement group_id="O2" value="2.3" spread="1.2"/>
                    <measurement group_id="O3" value="6.8" spread="2.6"/>
                    <measurement group_id="O4" value="10.0" spread="5.7"/>
                    <measurement group_id="O5" value="11.2" spread="6.6"/>
                    <measurement group_id="O6" value="5.5" spread="4.5"/>
                    <measurement group_id="O7" value="18.4" spread="11.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 Hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3" spread="0.9"/>
                    <measurement group_id="O2" value="2.3" spread="1.4"/>
                    <measurement group_id="O3" value="6.7" spread="2.4"/>
                    <measurement group_id="O4" value="10.1" spread="5.5"/>
                    <measurement group_id="O5" value="11.7" spread="7.9"/>
                    <measurement group_id="O6" value="6.4" spread="4.5"/>
                    <measurement group_id="O7" value="20.9" spread="19.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 Hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7" spread="1.0"/>
                    <measurement group_id="O2" value="2.3" spread="1.6"/>
                    <measurement group_id="O3" value="7.1" spread="2.5"/>
                    <measurement group_id="O4" value="4.9" spread="4.0"/>
                    <measurement group_id="O5" value="10.0" spread="3.7"/>
                    <measurement group_id="O6" value="5.4" spread="3.2"/>
                    <measurement group_id="O7" value="16.7" spread="12.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" spread="0.5"/>
                    <measurement group_id="O2" value="0.9" spread="0.4"/>
                    <measurement group_id="O3" value="3.2" spread="2.8"/>
                    <measurement group_id="O4" value="2.2" spread="1.7"/>
                    <measurement group_id="O5" value="3.7" spread="3.4"/>
                    <measurement group_id="O6" value="2.5" spread="3.1"/>
                    <measurement group_id="O7" value="5.5" spread="4.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" spread="0.5"/>
                    <measurement group_id="O2" value="0.9" spread="0.4"/>
                    <measurement group_id="O3" value="1.1" spread="0.4"/>
                    <measurement group_id="O4" value="1.4" spread="1.0"/>
                    <measurement group_id="O5" value="1.2" spread="0.6"/>
                    <measurement group_id="O6" value="1.3" spread="1.4"/>
                    <measurement group_id="O7" value="2.5" spread="3.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" spread="0.5"/>
                    <measurement group_id="O2" value="0.9" spread="0.4"/>
                    <measurement group_id="O3" value="1.0" spread="0.0"/>
                    <measurement group_id="O4" value="1.0" spread="0.0"/>
                    <measurement group_id="O5" value="1.0" spread="0.0"/>
                    <measurement group_id="O6" value="0.9" spread="0.4"/>
                    <measurement group_id="O7" value="1.7" spread="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" spread="0.5"/>
                    <measurement group_id="O2" value="0.9" spread="0.4"/>
                    <measurement group_id="O3" value="1.0" spread="0.0"/>
                    <measurement group_id="O4" value="1.0" spread="0.0"/>
                    <measurement group_id="O5" value="1.0" spread="0.0"/>
                    <measurement group_id="O6" value="0.9" spread="0.4"/>
                    <measurement group_id="O7" value="1.0" spread="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" spread="0.5"/>
                    <measurement group_id="O2" value="0.9" spread="0.4"/>
                    <measurement group_id="O3" value="1.0" spread="0.0"/>
                    <measurement group_id="O4" value="1.0" spread="0.0"/>
                    <measurement group_id="O5" value="1.0" spread="0.0"/>
                    <measurement group_id="O6" value="0.9" spread="0.4"/>
                    <measurement group_id="O7" value="1.0" spread="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Plasma Concentrations of Oxfendazole Sulfone</title>
        <description>Concentrations of oxfendazole sulfone in plasma were measured using a validated HPLCMS/MS method. Concentrations &lt;LLOQ (2 ng/mL) set to LLOQ/2 if after 1st =LLOQ concentration or 0 otherwise for calculating summary statistics.</description>
        <time_frame>Day 1-Day15</time_frame>
        <population>All participants receiving oxfendazole are included in the analysis population</population>
        <group_list>
          <group group_id="O1">
            <title>0.5 mg/kg Oxfendazole</title>
            <description>Participants received a single oral dose 0.5 mg/kg of oxfendazole.</description>
          </group>
          <group group_id="O2">
            <title>1 mg/kg Oxfendazole</title>
            <description>Participants received a single oral dose 1 mg/kg of oxfendazole</description>
          </group>
          <group group_id="O3">
            <title>3 mg/kg Oxfendazole</title>
            <description>Participants received a single oral dose 3 mg/kg of oxfendazole</description>
          </group>
          <group group_id="O4">
            <title>7.5 mg/kg Oxfendazole</title>
            <description>Participants received a single oral dose 7.5 mg/kg of oxfendazole</description>
          </group>
          <group group_id="O5">
            <title>15 mg/kg Oxfendazole</title>
            <description>Participants received a single oral dose 15 mg/kg of oxfendazole</description>
          </group>
          <group group_id="O6">
            <title>30 mg/kg Oxfendazole</title>
            <description>Participants received a single oral dose 30 mg/kg of oxfendazole</description>
          </group>
          <group group_id="O7">
            <title>60 mg/kg Oxfendazole</title>
            <description>Participants received a single oral dose 60 mg/kg of oxfendazole</description>
          </group>
        </group_list>
        <measure>
          <title>Plasma Concentrations of Oxfendazole Sulfone</title>
          <description>Concentrations of oxfendazole sulfone in plasma were measured using a validated HPLCMS/MS method. Concentrations &lt;LLOQ (2 ng/mL) set to LLOQ/2 if after 1st =LLOQ concentration or 0 otherwise for calculating summary statistics.</description>
          <population>All participants receiving oxfendazole are included in the analysis population</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="8"/>
                <count group_id="O5" value="8"/>
                <count group_id="O6" value="8"/>
                <count group_id="O7" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>1 Hour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.5" spread="4.6"/>
                    <measurement group_id="O2" value="31.1" spread="11.1"/>
                    <measurement group_id="O3" value="73.0" spread="24.1"/>
                    <measurement group_id="O4" value="100.5" spread="25.4"/>
                    <measurement group_id="O5" value="111.6" spread="51.9"/>
                    <measurement group_id="O6" value="161.5" spread="41.3"/>
                    <measurement group_id="O7" value="209.1" spread="84.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 Hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48.7" spread="9.3"/>
                    <measurement group_id="O2" value="56.0" spread="11.3"/>
                    <measurement group_id="O3" value="106.3" spread="31.5"/>
                    <measurement group_id="O4" value="182.3" spread="51.6"/>
                    <measurement group_id="O5" value="219.2" spread="73.0"/>
                    <measurement group_id="O6" value="262.6" spread="72.5"/>
                    <measurement group_id="O7" value="319.0" spread="119.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 Hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52.3" spread="8.6"/>
                    <measurement group_id="O2" value="67.6" spread="16.0"/>
                    <measurement group_id="O3" value="108.1" spread="25.7"/>
                    <measurement group_id="O4" value="223.8" spread="62.5"/>
                    <measurement group_id="O5" value="258.6" spread="73.0"/>
                    <measurement group_id="O6" value="285.7" spread="74.5"/>
                    <measurement group_id="O7" value="345.4" spread="133.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.3" spread="15.1"/>
                    <measurement group_id="O2" value="75.1" spread="26.6"/>
                    <measurement group_id="O3" value="113.8" spread="26.2"/>
                    <measurement group_id="O4" value="264.1" spread="63.0"/>
                    <measurement group_id="O5" value="308.3" spread="98.8"/>
                    <measurement group_id="O6" value="330.3" spread="90.1"/>
                    <measurement group_id="O7" value="404.6" spread="154.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8 Hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59.7" spread="13.7"/>
                    <measurement group_id="O2" value="78.2" spread="27.0"/>
                    <measurement group_id="O3" value="135.5" spread="33.9"/>
                    <measurement group_id="O4" value="296.2" spread="71.5"/>
                    <measurement group_id="O5" value="336.8" spread="72.2"/>
                    <measurement group_id="O6" value="356.3" spread="120.1"/>
                    <measurement group_id="O7" value="454.8" spread="174.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>10 Hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62.8" spread="22.3"/>
                    <measurement group_id="O2" value="70.7" spread="28.5"/>
                    <measurement group_id="O3" value="119.4" spread="18.7"/>
                    <measurement group_id="O4" value="308.7" spread="120.1"/>
                    <measurement group_id="O5" value="340.8" spread="68.1"/>
                    <measurement group_id="O6" value="352.4" spread="106.0"/>
                    <measurement group_id="O7" value="470.7" spread="182.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 Hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56.8" spread="17.5"/>
                    <measurement group_id="O2" value="65.4" spread="30.9"/>
                    <measurement group_id="O3" value="111.4" spread="12.4"/>
                    <measurement group_id="O4" value="296.0" spread="90.3"/>
                    <measurement group_id="O5" value="359.3" spread="102.1"/>
                    <measurement group_id="O6" value="343.7" spread="111.7"/>
                    <measurement group_id="O7" value="487.7" spread="210.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 Hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.9" spread="23.4"/>
                    <measurement group_id="O2" value="38.9" spread="31.7"/>
                    <measurement group_id="O3" value="68.5" spread="21.0"/>
                    <measurement group_id="O4" value="176.7" spread="125.5"/>
                    <measurement group_id="O5" value="261.8" spread="83.4"/>
                    <measurement group_id="O6" value="185.2" spread="90.5"/>
                    <measurement group_id="O7" value="362.2" spread="222.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.4" spread="11.8"/>
                    <measurement group_id="O2" value="11.1" spread="10.3"/>
                    <measurement group_id="O3" value="20.8" spread="12.2"/>
                    <measurement group_id="O4" value="64.8" spread="94.9"/>
                    <measurement group_id="O5" value="75.1" spread="47.6"/>
                    <measurement group_id="O6" value="57.5" spread="54.4"/>
                    <measurement group_id="O7" value="119.5" spread="86.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.6" spread="3.1"/>
                    <measurement group_id="O2" value="2.8" spread="3.5"/>
                    <measurement group_id="O3" value="5.7" spread="3.8"/>
                    <measurement group_id="O4" value="17.3" spread="27.2"/>
                    <measurement group_id="O5" value="16.7" spread="15.1"/>
                    <measurement group_id="O6" value="17.2" spread="23.6"/>
                    <measurement group_id="O7" value="33.8" spread="28.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2" spread="0.4"/>
                    <measurement group_id="O2" value="1.3" spread="1.0"/>
                    <measurement group_id="O3" value="1.3" spread="0.8"/>
                    <measurement group_id="O4" value="6.4" spread="10.2"/>
                    <measurement group_id="O5" value="1.2" spread="0.6"/>
                    <measurement group_id="O6" value="4.0" spread="7.7"/>
                    <measurement group_id="O7" value="6.6" spread="9.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" spread="0.0"/>
                    <measurement group_id="O2" value="1.0" spread="0.0"/>
                    <measurement group_id="O3" value="1.0" spread="0.0"/>
                    <measurement group_id="O4" value="1.0" spread="0.0"/>
                    <measurement group_id="O5" value="1.0" spread="0.0"/>
                    <measurement group_id="O6" value="1.0" spread="0.0"/>
                    <measurement group_id="O7" value="1.1" spread="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" spread="0.0"/>
                    <measurement group_id="O2" value="1.0" spread="0.0"/>
                    <measurement group_id="O3" value="1.0" spread="0.0"/>
                    <measurement group_id="O4" value="1.0" spread="0.0"/>
                    <measurement group_id="O5" value="1.0" spread="0.0"/>
                    <measurement group_id="O6" value="1.0" spread="0.0"/>
                    <measurement group_id="O7" value="1.0" spread="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Terminal Elimination Half-life (t1/2) of Oxfendazole</title>
        <description>The apparent terminal elimination half-life (t1/2) was defined as the time required for the drug concentration to decrease by a factor of one-half in the terminal phase computed from concentrations that were measured using a validated HPLCMS/MS method.</description>
        <time_frame>0, 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 336 hours post-dose</time_frame>
        <population>All participants receiving oxfendazole are included in the analysis population.</population>
        <group_list>
          <group group_id="O1">
            <title>0.5 mg/kg Oxfendazole</title>
            <description>Participants received a single oral dose 0.5 mg/kg of oxfendazole.</description>
          </group>
          <group group_id="O2">
            <title>1 mg/kg Oxfendazole</title>
            <description>Participants received a single oral dose 1 mg/kg of oxfendazole</description>
          </group>
          <group group_id="O3">
            <title>3 mg/kg Oxfendazole</title>
            <description>Participants received a single oral dose 3 mg/kg of oxfendazole</description>
          </group>
          <group group_id="O4">
            <title>7.5 mg/kg Oxfendazole</title>
            <description>Participants received a single oral dose 7.5 mg/kg of oxfendazole</description>
          </group>
          <group group_id="O5">
            <title>15 mg/kg Oxfendazole</title>
            <description>Participants received a single oral dose 15 mg/kg of oxfendazole</description>
          </group>
          <group group_id="O6">
            <title>30 mg/kg Oxfendazole</title>
            <description>Participants received a single oral dose 30 mg/kg of oxfendazole</description>
          </group>
          <group group_id="O7">
            <title>60 mg/kg Oxfendazole</title>
            <description>Participants received a single oral dose 60 mg/kg of oxfendazole</description>
          </group>
        </group_list>
        <measure>
          <title>Terminal Elimination Half-life (t1/2) of Oxfendazole</title>
          <description>The apparent terminal elimination half-life (t1/2) was defined as the time required for the drug concentration to decrease by a factor of one-half in the terminal phase computed from concentrations that were measured using a validated HPLCMS/MS method.</description>
          <population>All participants receiving oxfendazole are included in the analysis population.</population>
          <units>hours</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="8"/>
                <count group_id="O5" value="8"/>
                <count group_id="O6" value="8"/>
                <count group_id="O7" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.1" spread="27.5"/>
                    <measurement group_id="O2" value="8.5" spread="25.3"/>
                    <measurement group_id="O3" value="10.3" spread="35.7"/>
                    <measurement group_id="O4" value="9.6" spread="34.2"/>
                    <measurement group_id="O5" value="10.0" spread="21.8"/>
                    <measurement group_id="O6" value="9.8" spread="33.7"/>
                    <measurement group_id="O7" value="11.0" spread="44.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time of Maximum Observed Concentration (Tmax) of Oxfendazole</title>
        <description>Tmax was defined as the time at which the maximum concentration (Cmax) occurs in plasma computed from concentrations that were measured using a validated HPLCMS/MS method.</description>
        <time_frame>0, 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 336 hours post-dose</time_frame>
        <population>All participants receiving oxfendazole are included in the analysis population.</population>
        <group_list>
          <group group_id="O1">
            <title>0.5 mg/kg Oxfendazole</title>
            <description>Participants received a single oral dose 0.5 mg/kg of oxfendazole.</description>
          </group>
          <group group_id="O2">
            <title>1 mg/kg Oxfendazole</title>
            <description>Participants received a single oral dose 1 mg/kg of oxfendazole</description>
          </group>
          <group group_id="O3">
            <title>3 mg/kg Oxfendazole</title>
            <description>Participants received a single oral dose 3 mg/kg of oxfendazole</description>
          </group>
          <group group_id="O4">
            <title>7.5 mg/kg Oxfendazole</title>
            <description>Participants received a single oral dose 7.5 mg/kg of oxfendazole</description>
          </group>
          <group group_id="O5">
            <title>15 mg/kg Oxfendazole</title>
            <description>Participants received a single oral dose 15 mg/kg of oxfendazole</description>
          </group>
          <group group_id="O6">
            <title>30 mg/kg Oxfendazole</title>
            <description>Participants received a single oral dose 30 mg/kg of oxfendazole</description>
          </group>
          <group group_id="O7">
            <title>60 mg/kg Oxfendazole</title>
            <description>Participants received a single oral dose 60 mg/kg of oxfendazole</description>
          </group>
        </group_list>
        <measure>
          <title>Time of Maximum Observed Concentration (Tmax) of Oxfendazole</title>
          <description>Tmax was defined as the time at which the maximum concentration (Cmax) occurs in plasma computed from concentrations that were measured using a validated HPLCMS/MS method.</description>
          <population>All participants receiving oxfendazole are included in the analysis population.</population>
          <units>hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="8"/>
                <count group_id="O5" value="8"/>
                <count group_id="O6" value="8"/>
                <count group_id="O7" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" lower_limit="2.0" upper_limit="2.1"/>
                    <measurement group_id="O2" value="2.0" lower_limit="1.0" upper_limit="6.0"/>
                    <measurement group_id="O3" value="2.0" lower_limit="1.0" upper_limit="2.0"/>
                    <measurement group_id="O4" value="2.0" lower_limit="1.0" upper_limit="4.0"/>
                    <measurement group_id="O5" value="2.0" lower_limit="2.0" upper_limit="9.5"/>
                    <measurement group_id="O6" value="2.0" lower_limit="1.9" upper_limit="6.0"/>
                    <measurement group_id="O7" value="2.0" lower_limit="1.4" upper_limit="7.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Urine Concentrations of Oxfendazole Fenbendazole</title>
        <description>Concentrations of oxfendazole fenbendazole in urine were measured using a validated HPLCMS/MS method. Concentrations &lt;LLOQ (2 ng/mL) set to LLOQ/2 if after 1st =LLOQ concentration or 0 otherwise for calculating summary statistics.</description>
        <time_frame>Day 1-Day 15</time_frame>
        <population>All participants receiving oxfendazole are included in the analysis population.</population>
        <group_list>
          <group group_id="O1">
            <title>0.5 mg/kg Oxfendazole</title>
            <description>Participants received a single oral dose 0.5 mg/kg of oxfendazole.</description>
          </group>
          <group group_id="O2">
            <title>1 mg/kg Oxfendazole</title>
            <description>Participants received a single oral dose 1 mg/kg of oxfendazole</description>
          </group>
          <group group_id="O3">
            <title>3 mg/kg Oxfendazole</title>
            <description>Participants received a single oral dose 3 mg/kg of oxfendazole</description>
          </group>
          <group group_id="O4">
            <title>7.5 mg/kg Oxfendazole</title>
            <description>Participants received a single oral dose 7.5 mg/kg of oxfendazole</description>
          </group>
          <group group_id="O5">
            <title>15 mg/kg Oxfendazole</title>
            <description>Participants received a single oral dose 15 mg/kg of oxfendazole</description>
          </group>
          <group group_id="O6">
            <title>30 mg/kg Oxfendazole</title>
            <description>Participants received a single oral dose 30 mg/kg of oxfendazole</description>
          </group>
          <group group_id="O7">
            <title>60 mg/kg Oxfendazole</title>
            <description>Participants received a single oral dose 60 mg/kg of oxfendazole</description>
          </group>
        </group_list>
        <measure>
          <title>Urine Concentrations of Oxfendazole Fenbendazole</title>
          <description>Concentrations of oxfendazole fenbendazole in urine were measured using a validated HPLCMS/MS method. Concentrations &lt;LLOQ (2 ng/mL) set to LLOQ/2 if after 1st =LLOQ concentration or 0 otherwise for calculating summary statistics.</description>
          <population>All participants receiving oxfendazole are included in the analysis population.</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="8"/>
                <count group_id="O5" value="8"/>
                <count group_id="O6" value="8"/>
                <count group_id="O7" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>0-4 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="0"/>
                    <measurement group_id="O2" value="0" spread="0"/>
                    <measurement group_id="O3" value="0" spread="0"/>
                    <measurement group_id="O4" value="0" spread="0"/>
                    <measurement group_id="O5" value="0" spread="0"/>
                    <measurement group_id="O6" value="0" spread="0"/>
                    <measurement group_id="O7" value="0" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4-8 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="0"/>
                    <measurement group_id="O2" value="0" spread="0"/>
                    <measurement group_id="O3" value="0" spread="0"/>
                    <measurement group_id="O4" value="0" spread="0"/>
                    <measurement group_id="O5" value="0" spread="0"/>
                    <measurement group_id="O6" value="0" spread="0"/>
                    <measurement group_id="O7" value="0" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8-12 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="0"/>
                    <measurement group_id="O2" value="0" spread="0"/>
                    <measurement group_id="O3" value="0" spread="0"/>
                    <measurement group_id="O4" value="0" spread="0"/>
                    <measurement group_id="O5" value="0" spread="0"/>
                    <measurement group_id="O6" value="0" spread="0"/>
                    <measurement group_id="O7" value="0" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12-24 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="0"/>
                    <measurement group_id="O2" value="0" spread="0"/>
                    <measurement group_id="O3" value="0" spread="0"/>
                    <measurement group_id="O4" value="0" spread="0"/>
                    <measurement group_id="O5" value="0" spread="0"/>
                    <measurement group_id="O6" value="0" spread="0"/>
                    <measurement group_id="O7" value="0" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24-32 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="0"/>
                    <measurement group_id="O2" value="0" spread="0"/>
                    <measurement group_id="O3" value="0" spread="0"/>
                    <measurement group_id="O4" value="0" spread="0"/>
                    <measurement group_id="O5" value="0" spread="0"/>
                    <measurement group_id="O6" value="0" spread="0"/>
                    <measurement group_id="O7" value="0.03" spread="0.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>48-60 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="0"/>
                    <measurement group_id="O2" value="0" spread="0"/>
                    <measurement group_id="O3" value="0" spread="0"/>
                    <measurement group_id="O4" value="0.28" spread="0.78"/>
                    <measurement group_id="O5" value="0" spread="0"/>
                    <measurement group_id="O6" value="0" spread="0"/>
                    <measurement group_id="O7" value="0" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Urine Concentrations of Oxfendazole Sulfone</title>
        <description>Concentrations of oxfendazole sulfone in urine were measured using a validated HPLCMS/MS method. Concentrations &lt;LLOQ (2 ng/mL) set to LLOQ/2 if after 1st =LLOQ concentration or 0 otherwise for calculating summary statistics.</description>
        <time_frame>Day 1-Day 15</time_frame>
        <population>All participants receiving oxfendazole are included in the analysis population.</population>
        <group_list>
          <group group_id="O1">
            <title>0.5 mg/kg Oxfendazole</title>
            <description>Participants received a single oral dose 0.5 mg/kg of oxfendazole.</description>
          </group>
          <group group_id="O2">
            <title>1 mg/kg Oxfendazole</title>
            <description>Participants received a single oral dose 1 mg/kg of oxfendazole</description>
          </group>
          <group group_id="O3">
            <title>3 mg/kg Oxfendazole</title>
            <description>Participants received a single oral dose 3 mg/kg of oxfendazole</description>
          </group>
          <group group_id="O4">
            <title>7.5 mg/kg Oxfendazole</title>
            <description>Participants received a single oral dose 7.5 mg/kg of oxfendazole</description>
          </group>
          <group group_id="O5">
            <title>15 mg/kg Oxfendazole</title>
            <description>Participants received a single oral dose 15 mg/kg of oxfendazole</description>
          </group>
          <group group_id="O6">
            <title>30 mg/kg Oxfendazole</title>
            <description>Participants received a single oral dose 30 mg/kg of oxfendazole</description>
          </group>
          <group group_id="O7">
            <title>60 mg/kg Oxfendazole</title>
            <description>Participants received a single oral dose 60 mg/kg of oxfendazole</description>
          </group>
        </group_list>
        <measure>
          <title>Urine Concentrations of Oxfendazole Sulfone</title>
          <description>Concentrations of oxfendazole sulfone in urine were measured using a validated HPLCMS/MS method. Concentrations &lt;LLOQ (2 ng/mL) set to LLOQ/2 if after 1st =LLOQ concentration or 0 otherwise for calculating summary statistics.</description>
          <population>All participants receiving oxfendazole are included in the analysis population.</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="8"/>
                <count group_id="O5" value="8"/>
                <count group_id="O6" value="8"/>
                <count group_id="O7" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>0-4 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.1" spread="16.8"/>
                    <measurement group_id="O2" value="4.1" spread="11.6"/>
                    <measurement group_id="O3" value="19.9" spread="25.7"/>
                    <measurement group_id="O4" value="45.6" spread="37.0"/>
                    <measurement group_id="O5" value="46.4" spread="20.9"/>
                    <measurement group_id="O6" value="68.0" spread="21.2"/>
                    <measurement group_id="O7" value="64.5" spread="44.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4-8 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.9" spread="13.8"/>
                    <measurement group_id="O2" value="24.9" spread="18.3"/>
                    <measurement group_id="O3" value="38.2" spread="20.3"/>
                    <measurement group_id="O4" value="86.0" spread="68.9"/>
                    <measurement group_id="O5" value="88.1" spread="27.6"/>
                    <measurement group_id="O6" value="105.8" spread="36.4"/>
                    <measurement group_id="O7" value="124.1" spread="72.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8-12 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.1" spread="50.3"/>
                    <measurement group_id="O2" value="26.5" spread="22.9"/>
                    <measurement group_id="O3" value="30.3" spread="14.7"/>
                    <measurement group_id="O4" value="76.0" spread="60.1"/>
                    <measurement group_id="O5" value="92.3" spread="33.3"/>
                    <measurement group_id="O6" value="99.7" spread="40.8"/>
                    <measurement group_id="O7" value="92.9" spread="39.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12-24 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.9" spread="29.1"/>
                    <measurement group_id="O2" value="26.3" spread="33.7"/>
                    <measurement group_id="O3" value="15.8" spread="18.5"/>
                    <measurement group_id="O4" value="100.4" spread="87.2"/>
                    <measurement group_id="O5" value="91.8" spread="46.7"/>
                    <measurement group_id="O6" value="69.9" spread="49.0"/>
                    <measurement group_id="O7" value="139.0" spread="137.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24-32 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="0"/>
                    <measurement group_id="O2" value="0.9" spread="2.6"/>
                    <measurement group_id="O3" value="1.2" spread="3.4"/>
                    <measurement group_id="O4" value="3.2" spread="4.9"/>
                    <measurement group_id="O5" value="7.5" spread="9.1"/>
                    <measurement group_id="O6" value="18.2" spread="32.4"/>
                    <measurement group_id="O7" value="26.1" spread="32.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>48-60 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="0"/>
                    <measurement group_id="O2" value="0" spread="0"/>
                    <measurement group_id="O3" value="0" spread="0"/>
                    <measurement group_id="O4" value="0.8" spread="1.6"/>
                    <measurement group_id="O5" value="0" spread="0"/>
                    <measurement group_id="O6" value="7.3" spread="9.7"/>
                    <measurement group_id="O7" value="5.3" spread="7.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>0.5 mg/kg Oxfendazole</title>
          <description>Participants received a single oral dose 0.5 mg/kg of oxfendazole.</description>
        </group>
        <group group_id="E2">
          <title>1 mg/kg Oxfendazole</title>
          <description>Participants received a single oral dose 1 mg/kg of oxfendazole</description>
        </group>
        <group group_id="E3">
          <title>3 mg/kg Oxfendazole</title>
          <description>Participants received a single oral dose 3 mg/kg of oxfendazole</description>
        </group>
        <group group_id="E4">
          <title>7.5 mg/kg Oxfendazole</title>
          <description>Participants received a single oral dose 7.5 mg/kg of oxfendazole</description>
        </group>
        <group group_id="E5">
          <title>15 mg/kg Oxfendazole</title>
          <description>Participants received a single oral dose 15 mg/kg of oxfendazole</description>
        </group>
        <group group_id="E6">
          <title>30 mg/kg Oxfendazole</title>
          <description>Participants received a single oral dose 30 mg/kg of oxfendazole</description>
        </group>
        <group group_id="E7">
          <title>60 mg/kg Oxfendazole</title>
          <description>Participants received a single oral dose 60 mg/kg of oxfendazole</description>
        </group>
        <group group_id="E8">
          <title>Placebo</title>
          <description>Participants received a single placebo formulation consisting of 4.5% polyethylene glycol, 0.18% methyl paraben, and 95.32% sterile water for injection</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA (18.1)</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Gastroenteritis Viral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Upper Respiratory Tract Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Skin Abrasion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Electrocardiogram PR Prolongation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nasal Congestion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Oropharyngeal Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis Contact</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Hand Dermatitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Patricia Winokur, MD</name_or_title>
      <organization>University of Iowa</organization>
      <phone>319-384-1735</phone>
      <email>patricia-winokur@uiowa.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02234570
org study id: 12-0053
nct id: NCT02234570
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
The objectives of the Phase I study are to evaluate the safety and tolerance of increasing
      single oral doses of oxfendazole in healthy volunteers.The secondary objectives assess the
      pharmacokinetic profile of oxfendazole and assess the metabolism of oxfendazole. The
      description of agent used is single oral dose of an aqueous suspension of oxfendazole, a
      benzimidazole carbamate antiparasitic drug. Each new cohort will be dosed only after the two
      week safety data for the preceding group have been reviewed. If a clinically significant AE
      is observed, and if this event is drug-related the safety monitoring committee will be
      convened to determine whether the study should continue.
This Phase I study is a randomized, double-blind, placebo-controlled evaluation of the safety
      and pharmacokinetics of escalating single oral doses of oxfendazole (0.5 to 60 mg/kg) in
      healthy volunteers. Up to 70 healthy males and females (non-chldbearing potential), ages
      18-45 volunteers recruited from one site will participate in this study. The study duration
      is approximately 18 months with subject participation of 2 weeks. The primary objective
      assess the safety and tolerability of oxfendazole in healthy adults. The secondary objectives
      assess the pharmacokinetic profile of oxfendazole and assess the metabolism of oxfendazole.
      Two sentinel subjects will receive the study product (1 drug/1 placebo) in each group and be
      monitored 48 hours for adverse events prior to completing enrollment of the remaining 8
      subjects in the group.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Number of Subjects Reporting Adverse Events Related to Oxfendazole Within 14 Days of Receipt of a Single Oral Dose.
time frame: Within 14 Days of first dose
description: All adverse events, defined as any untoward medical occurrence regardless of its causal relationship to the study treatment, were collected for 14 days after dosing. The PI then determined relatedness to the study drug. Related was defined as "there is a reasonable possibility that the study product caused the adverse event. Reasonable possibility means that there is evidence to suggest a causal relationship between the study product and the adverse event."
measure: Area Under the Concentration Time-curve From Time Zero to Infinity (AUC(0-infinity)) for Oxfendazole
time frame: 0, 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 336 hours post-dose
description: AUC(0-infinity) was defined as the total area under the concentration-time curve from dosing (time 0) taken to the limit as the end time becomes arbitrarily large. AUC(0-infinity) and was calculated by adding AUC(0-last) to an extrapolated value equal to the last measured concentration greater than the lower limit of quantification of the bioanalytical assay divided by the terminal phase elimination rate constant (Ke) computed from concentrations that were measured using a validated HPLCMS/MS method
measure: Maximum Observed Concentration (Cmax) of Oxfendazole in Plasma
time frame: 0, 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 336 hours post-dose
description: Cmax is defined as the maximum observed drug concentration observed in plasma over all PK sample concentrations computed from concentrations that were measured using a validated HPLC-MS/MS method.
measure: Plasma Concentrations of Oxfendazole Fenbendazole
time frame: Day 1-Day15
description: Concentrations of oxfendazole fenbendazole in plasma were measured using a validated HPLCMS/MS method. Concentrations <LLOQ (2 ng/mL) set to LLOQ/2 if after 1st =LLOQ concentration or 0 otherwise for calculating summary statistics.
measure: Plasma Concentrations of Oxfendazole Sulfone
time frame: Day 1-Day15
description: Concentrations of oxfendazole sulfone in plasma were measured using a validated HPLCMS/MS method. Concentrations <LLOQ (2 ng/mL) set to LLOQ/2 if after 1st =LLOQ concentration or 0 otherwise for calculating summary statistics.
measure: Terminal Elimination Half-life (t1/2) of Oxfendazole
time frame: 0, 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 336 hours post-dose
description: The apparent terminal elimination half-life (t1/2) was defined as the time required for the drug concentration to decrease by a factor of one-half in the terminal phase computed from concentrations that were measured using a validated HPLCMS/MS method.
measure: Time of Maximum Observed Concentration (Tmax) of Oxfendazole
time frame: 0, 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 336 hours post-dose
description: Tmax was defined as the time at which the maximum concentration (Cmax) occurs in plasma computed from concentrations that were measured using a validated HPLCMS/MS method.
measure: Urine Concentrations of Oxfendazole Fenbendazole
time frame: Day 1-Day 15
description: Concentrations of oxfendazole fenbendazole in urine were measured using a validated HPLCMS/MS method. Concentrations <LLOQ (2 ng/mL) set to LLOQ/2 if after 1st =LLOQ concentration or 0 otherwise for calculating summary statistics.
measure: Urine Concentrations of Oxfendazole Sulfone
time frame: Day 1-Day 15
description: Concentrations of oxfendazole sulfone in urine were measured using a validated HPLCMS/MS method. Concentrations <LLOQ (2 ng/mL) set to LLOQ/2 if after 1st =LLOQ concentration or 0 otherwise for calculating summary statistics.
arm group label: Group 1
arm group type: Experimental
description: N=8 subjects receive single oral dose 0.5mg/kg of oxfendazole; N= 2 subjects receive single oral dose placebo
arm group label: Group 2
arm group type: Experimental
description: N=8 subjects receive single oral dose 1mg/kg of oxfendazole; N=2 subjects receive single oral dose placebo
arm group label: Group 3
arm group type: Experimental
description: N=8 subjects receive single oral dose 3mg/kg of oxfendazole; N= 2 subjects receive single oral dose placebo
arm group label: Group 4
arm group type: Experimental
description: N=8 subjects receive single oral dose 7.5mg/kg of oxfendazole; N=2 subjects receive single oral dose placebo
arm group label: Group 5
arm group type: Experimental
description: N=8 subjects receive single oral dose 15mg/kg of oxfendazole; N= 2 subjects receive single oral dose placebo
arm group label: Group 6
arm group type: Experimental
description: N=8 subjects receive single oral dose 30mg/kg of oxfendazole; N=2 subjects receive single oral dose placebo
arm group label: Group 7
arm group type: Experimental
description: N=8 subjects receive single oral dose 60mg/kg of oxfendazole; N=2 subjects receive single oral dose placebo
intervention type: Drug
intervention name: Oxfendazole
description: A benzimidazole carbamate antiparasitic drug. Oral Dose levels of 0.5,1, 3, 7.5, 15, 30, and 60 mg/kg will be evaluated sequentially, the dose increasing with each new cohort Group 1 to Group 7.
arm group label: Group 1
arm group label: Group 2
arm group label: Group 3
arm group label: Group 4
arm group label: Group 5
arm group label: Group 6
arm group label: Group 7
intervention type: Other
intervention name: Placebo
description: Normal Saline administered with an oral dosing syringe. Group 1- Group 6
arm group label: Group 1
arm group label: Group 2
arm group label: Group 3
arm group label: Group 4
arm group label: Group 5
arm group label: Group 6
arm group label: Group 7
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
mesh term: Neurocysticercosis
mesh term: Cysticercosis
mesh term: Taeniasis
mesh term: Oxfendazole
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 