<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/NCT03035760</url>
  </required_header>
  <id_info>
    <org_study_id>16-0005</org_study_id>
    <secondary_id>HHSN272201300020I</secondary_id>
    <nct_id>NCT03035760</nct_id>
  </id_info>
  <brief_title>Multiple Ascending Dose Study of Oxfendazole in Healthy Adult Volunteers</brief_title>
  <official_title>A Phase 1 Open Label, Multiple Ascending Dose Study of Oxfendazole in Healthy Adult Volunteers</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>
      This Phase I study is an open label multiple ascending dose evaluation of the safety and PK&#xD;
      of oxfendazole (3, 7.5, or 15 mg/kg) given orally daily to healthy adult men and nonpregnant&#xD;
      women aged 18-45 followed by a single dose cross over trial evaluating the safety and&#xD;
      pharmacokinetics of a single dose of oxfendazole (3 mg/kg) given following an 8 hour fast or&#xD;
      following a high fat meal. The study duration will be approximately 12 months with each&#xD;
      subject participation lasting approximately 6 weeks. In the multiple ascending dose&#xD;
      evaluation, between 8 and 24 subjects will be enrolled; each dose group will be comprised of&#xD;
      eight volunteers. To enhance safety, one sentinel subject will be dosed for five days and&#xD;
      monitored for 7 days from the time of the first dose for predefined adverse events. If there&#xD;
      are no predefined safety events, a second sentinel subject will be enrolled and followed for&#xD;
      a total of 7 days. If there are no predefined safety signals identified for either of these&#xD;
      two sentinel subjects, the remaining subjects in the group will be enrolled. After all eight&#xD;
      subjects have completed the 10 day follow up period, an electronic safety review of the&#xD;
      electronic data will be performed. If none of the predefined safety events have occurred DMID&#xD;
      will approve enrollment into the second dose group (7.5 mg/kg oxfendazole daily x 5 days) and&#xD;
      will be monitored for a total of 7 days each for predefined adverse events prior to enrolling&#xD;
      the remaining subjects in the group. After the 10 day follow up period has been completed for&#xD;
      group 2, an electronic safety review will be completed and if no predefined events have&#xD;
      occurred two sequential subjects (one at a time with 7 days between each subject) will be&#xD;
      enrolled into the third dose group (15 mg/kg oxfendazole daily x 5 days) and will be&#xD;
      monitored for a total of 7 days each for predefined safety events prior to enrolling the&#xD;
      remaining subjects in the group. In the food effects evaluation, 12 subjects will be enrolled&#xD;
      into the single dose cross over group where half of the subjects will initially receive a&#xD;
      single dose of 3 mg/kg of oxfendazole following an 8 hour fast and the other half will&#xD;
      receive a single dose of 3 mg/kg of oxfendazole following a high fat meal. Subjects will then&#xD;
      cross over to receive a single dose following a high fat breakfast or fasting period (water&#xD;
      is permitted). All subjects will have received a dose of oxfendazole following both a fasting&#xD;
      period and a meal. The primary objectives are: 1) To assess the safety of oxfendazole&#xD;
      administered daily for five days; and 2) To assess the safety of oxfendazole administered as&#xD;
      a single dose with or without food.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This Phase I study is an open label multiple ascending dose evaluation of the safety and PK&#xD;
      of oxfendazole (3, 7.5, or 15 mg/kg) given orally daily to healthy adult men and nonpregnant&#xD;
      women aged 18-45 followed by a single dose cross over trial evaluating the safety and&#xD;
      pharmacokinetics of a single dose of oxfendazole (3 mg/kg) given following an 8 hour fast or&#xD;
      following a high fat meal. The study duration will be approximately 12 months with each&#xD;
      subject participation lasting approximately 6 weeks. In the multiple ascending dose&#xD;
      evaluation, between 8 and 24 subjects will be enrolled; each dose group will be comprised of&#xD;
      eight volunteers. To enhance safety, one sentinel subject will be dosed for five days and&#xD;
      monitored for 7 days from the time of the first dose for predefined adverse events. If there&#xD;
      are no predefined safety events, a second sentinel subject will be enrolled and followed for&#xD;
      a total of 7 days. If there are no predefined safety signals identified for either of these&#xD;
      two sentinel subjects, the remaining subjects in the group will be enrolled. After all eight&#xD;
      subjects have completed the 10 day follow up period, an electronic safety review of the&#xD;
      electronic data will be performed. If none of the predefined safety events have occurred DMID&#xD;
      will approve enrollment into the second dose group (7.5 mg/kg oxfendazole daily x 5 days) and&#xD;
      will be monitored for a total of 7 days each for predefined adverse events prior to enrolling&#xD;
      the remaining subjects in the group. After the 10 day follow up period has been completed for&#xD;
      group 2, an electronic safety review will be completed and if no predefined events have&#xD;
      occurred two sequential subjects (one at a time with 7 days between each subject) will be&#xD;
      enrolled into the third dose group (15 mg/kg oxfendazole daily x 5 days) and will be&#xD;
      monitored for a total of 7 days each for predefined safety events prior to enrolling the&#xD;
      remaining subjects in the group. In the food effects evaluation, 12 subjects will be enrolled&#xD;
      into the single dose cross over group where half of the subjects will initially receive a&#xD;
      single dose of 3 mg/kg of oxfendazole following an 8 hour fast and the other half will&#xD;
      receive a single dose of 3 mg/kg of oxfendazole following a high fat meal. Subjects will then&#xD;
      cross over to receive a single dose following a high fat breakfast or fasting period (water&#xD;
      is permitted). All subjects will have received a dose of oxfendazole following both a fasting&#xD;
      period and a meal. The primary objectives are: 1) To assess the safety of oxfendazole&#xD;
      administered daily for five days; and 2) To assess the safety of oxfendazole administered as&#xD;
      a single dose with or without food. The secondary objectives are: 1) To define the multi-dose&#xD;
      kinetics of oxfendazole; and 2) To determine the effect of food on the kinetics of&#xD;
      oxfendazole.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 12, 2017</start_date>
  <completion_date type="Actual">April 23, 2019</completion_date>
  <primary_completion_date type="Actual">April 23, 2018</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Subjects Reporting Adverse Events (AEs) Related to Oxfendazole for Arms 1, 2, and 3</measure>
    <time_frame>Day 1 through Day 10</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>
  <primary_outcome>
    <measure>Number of Subjects Reporting Adverse Events (AEs) Related to Oxfendazole for Arm 4</measure>
    <time_frame>Day 1 through Day 14</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 for a Single Dosing Interval (AUCtau) of Oxfendazole for Arm 1, 2 and 3</measure>
    <time_frame>0, 0.5, 1, 2, 3, 4, 6, 9, 12, 24 hours post-dose on day 1 and 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 24, 72, 120 hours post-dose on day 5</time_frame>
    <description>AUCtau was defined as the total area under the concentration-time curve from dosing to the end of the 24-hour dosing interval for Dose 1 and Dose 5. AUCtau was calculated using the Linear Up Log Down calculation method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Concentration Time-curve to the Time of Last Measured Concentration (AUClast) of Oxfendazole for Arm 4</measure>
    <time_frame>0, 0.5, 1, 2, 3, 4, 6, 9, 12, 24 hours post-dose</time_frame>
    <description>AUClast was defined as the area under the concentration-time curve from dosing to the time of the last measured concentration of that dosing period greater than the lower limit of quantification of the bioanalytical assay. AUClast was calculated using the Linear Up Log Down calculation method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Observed Concentration (Cmax) of Oxfendazole in Plasma for Arms 1, 2, and 3</measure>
    <time_frame>0, 0.5, 1, 2, 3, 4, 6, 9, 12, 24 hours post-dose on day 1 and 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 24, 72, 120 hours post-dose on day 5</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>Maximum Observed Concentration (Cmax) of Oxfendazole in Plasma for Arm 4</measure>
    <time_frame>0, 0.5, 1, 2, 3, 4, 6, 9, 12, 24 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>Terminal Elimination Half-life (t1/2) of Oxfendazole for Arms 1, 2, and 3</measure>
    <time_frame>0, 0.5, 1, 2, 3, 4, 6, 9, 12, 24 hours post-dose on day 1 and 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 24, 72, 120 hours post-dose on day 5</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>Terminal Elimination Half-life (t1/2) of Oxfendazole for Arm 4</measure>
    <time_frame>0, 0.5, 1, 2, 3, 4, 6, 9, 12, 24 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 for Arms 1, 2, and 3</measure>
    <time_frame>0, 0.5, 1, 2, 3, 4, 6, 9, 12, 24 hours post-dose on day 1 and 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 24, 72, 120 hours post-dose on day 5</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>Time of Maximum Observed Concentration (Tmax) of Oxfendazole for Arm 4</measure>
    <time_frame>0, 0.5, 1, 2, 3, 4, 6, 9, 12, 24 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>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Helminthic Infection</condition>
  <arm_group>
    <arm_group_label>1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>3 mg/kg orally once daily for 5 days (n = 8)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>7.5 mg/kg orally once daily for 5 days (n = 8)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>15 mg/kg orally once daily for 5 days (n = 8)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>3 mg/kg orally, one dose received following a fast (n=6) or high fat meal (n=6) on Day 1 and crossed over to opposite arm to receive drug following high fat meal or fast on Day 8</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxfendazole</intervention_name>
    <description>methyl-5 (6)-phenylsulfiyl-2-benzimidazole carbamate, is a broad spectrum benzimidazole antihelminthic. It is the sulphoxide metabolite of fenbendazole.</description>
    <arm_group_label>1</arm_group_label>
    <arm_group_label>2</arm_group_label>
    <arm_group_label>3</arm_group_label>
    <arm_group_label>4</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Males and nonpregnant females between the ages of 18 and 45 years, inclusive.&#xD;
&#xD;
          2. Women of childbearing potential* must agree to practice adequate contraception** for&#xD;
             the 28-day period before Day 0 through 4 months after the last dose of study&#xD;
             medication.&#xD;
&#xD;
             * A woman is considered of childbearing potential unless surgically sterile (tubal&#xD;
             ligation, bilateral oophorectomy, or hysterectomy) or post-menopausal (=1 year).&#xD;
&#xD;
             **Acceptable birth control methods include but are not limited to: abstinence from&#xD;
             sexual intercourse with men; monogamous relationship with a vasectomized partner;&#xD;
             double-barrier methods (condoms, diaphragms, spermicides); intrauterine devices; and&#xD;
             licensed hormonal methods.&#xD;
&#xD;
          3. In good health, as judged by the investigator and determined by vital signs*&#xD;
&#xD;
             *Temperature &lt; 38°C, heart rate &lt;= 100 bpm and &gt; 50 bpm, systolic blood pressure &lt;=&#xD;
             140 mmHg and &gt; 89 mmHg, diastolic blood pressure &lt;= 90 mmHg and = 60 mm Hg, medical&#xD;
             history and a targeted physical examination. BMI &gt;= 18 and &lt;= 35. Athletically trained&#xD;
             subjects with a pulse &gt;= 45 may be enrolled at the discretion of the principal&#xD;
             investigator or designated licensed clinical investigator. Acceptable screening&#xD;
             laboratories: Hemoglobin, white blood cell (WBC) count, neutrophil, and platelet&#xD;
             counts, INR and PTT within normal ranges. AST &lt; 44 and ALT &lt; 44 and total bilirubin,&#xD;
             creatinine must be equal to or below the upper limit of normal (creatinine values&#xD;
             below the normal range are acceptable). Random blood glucose must be &lt;140. Urine&#xD;
             dipstick testing must be negative for glucose and negative or trace for protein. The&#xD;
             following serology tests must be negative: HIV 1/2 antibody, hepatitis B surface&#xD;
             antigen (HBsAg), and hepatitis C virus (HCV) antibody. HIV and hepatitis C viral load&#xD;
             PCR testing may be performed for individuals suspected of having indeterminate&#xD;
             antibody testing.&#xD;
&#xD;
          4. Male participants must be willing to ensure use of condoms and spermicides for 4&#xD;
             months after the last dose study medication.&#xD;
&#xD;
          5. Provide written informed consent before initiation of any study procedures.&#xD;
&#xD;
          6. Willing to be available for all study-required procedures, and visits for the duration&#xD;
             of the study.&#xD;
&#xD;
          7. Individuals must agree to abstain from drug or alcohol use for 48 hours prior to&#xD;
             enrollment through day 10 or 14.&#xD;
&#xD;
          8. Able to provide a home phone number, and the name, address, and/or email of a person&#xD;
             willing to assist with making contact during the follow-up phase of the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnant women, women who are planning to become pregnant in the next 4 months, or&#xD;
             women who are breastfeeding.&#xD;
&#xD;
          2. Body temperature &gt;=100.4°F (&gt;=38.0°C) or acute illness within 3 days before&#xD;
             administration of study drug (subject may be rescheduled).&#xD;
&#xD;
          3. Chronic or acute medical disorder*&#xD;
&#xD;
               -  Disorders of the cardiac, pulmonary, liver, kidney, neurologic, gastrointestinal&#xD;
                  or other system, such that in the opinion of the investigator participation in&#xD;
                  the study creates additional risk to the subject, or to the validity of the&#xD;
                  study.&#xD;
&#xD;
          4. Use of chronic systemic medications* *Intermittent use of over the counter medications&#xD;
             such as acetaminophen, ibuprofen, cold and sinus medications are permitted for&#xD;
             enrollment Topical medications, nasal steroids are permitted throughout the study. Use&#xD;
             of prescription medications used less than once per week on average are permitted for&#xD;
             enrollment. If the subject has taken a short term prescription medication within the&#xD;
             past 30 days (e.g. an antibiotic), they should be postponed from enrollment until 30&#xD;
             days have elapsed since the last dose.&#xD;
&#xD;
          5. Has history of sensitivity to related benzimidazole compounds (e.g., albendazole,&#xD;
             mebendazole).&#xD;
&#xD;
          6. A diagnosis of schizophrenia, bipolar disease, or history of hospitalization for a&#xD;
             psychiatric condition or previous suicide attempt.&#xD;
&#xD;
          7. A history of treatment for any other psychiatric disorder in the past 3 years.*&#xD;
&#xD;
             *Past treatment for ADHD does not exclude participants from enrollment as long as the&#xD;
             medications have been discontinued for a minimum of 3 months and symptoms are well&#xD;
             controlled.&#xD;
&#xD;
          8. Received an experimental agent* within 1 month before administration of study drug or&#xD;
             expect to receive an experimental agent during the 10 or 14-day study period.&#xD;
&#xD;
             *Vaccine, drug, biologic, device, blood product, or medication.&#xD;
&#xD;
          9. Any condition that would, in the opinion of the investigator, interfere with the&#xD;
             study.*&#xD;
&#xD;
             *This includes any condition that would place them at an unacceptable risk of injury,&#xD;
             render them unable to meet the requirements of the protocol, or that may interfere&#xD;
             with successful completion of the study.&#xD;
&#xD;
         10. A history of heavy alcohol* or illicit drug use**, or history of substance abuse#.&#xD;
&#xD;
             *On average, greater than 7 alcoholic drinks per week. .&#xD;
&#xD;
             **Other than occasional marijuana use (less than once per week for the past 60 days is&#xD;
             acceptable).&#xD;
&#xD;
             #Alcohol or illicit drugs within the past 3 years.&#xD;
&#xD;
         11. History of chronic tobacco use in the past 60 days.* *A history of occasional tobacco&#xD;
             use (less than 1 pack per week on average) is acceptable. Individuals will be&#xD;
             counseled to abstain from use of tobacco and marijuana from screening through day 10&#xD;
             or 14.&#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>July 19, 2017</verification_date>
  <study_first_submitted>January 26, 2017</study_first_submitted>
  <study_first_submitted_qc>January 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <results_first_submitted>November 7, 2019</results_first_submitted>
  <results_first_submitted_qc>December 4, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">December 17, 2019</results_first_posted>
  <last_update_submitted>December 4, 2019</last_update_submitted>
  <last_update_submitted_qc>December 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 17, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Helminths</keyword>
  <keyword>Oxfendazole</keyword>
  <keyword>Pharmacokinetics</keyword>
  <keyword>Safety</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Helminthiasis</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>July 24, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/60/NCT03035760/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>October 9, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/60/NCT03035760/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 05JUN2017 and 10APR2018.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Arm 1: 3 mg/kg Oxfendazole for 5 Days</title>
          <description>Participants received 3 mg/kg oxfendazole orally once daily for 5 days</description>
        </group>
        <group group_id="P2">
          <title>Arm 2: 7.5 mg/kg Oxfendazole for 5 Days</title>
          <description>Participants received 7.5 mg/kg oxfendazole orally once daily for 5 days</description>
        </group>
        <group group_id="P3">
          <title>Arm 3: 15 mg/kg Oxfendazole for 5 Days</title>
          <description>Participants received 15 mg/kg oxfendazole orally once daily for 5 days</description>
        </group>
        <group group_id="P4">
          <title>Arm 4A: 3 mg/kg Oxfendazole Fasted First, Then High Fat Meal</title>
          <description>3 mg/kg oxfendazole orally, one dose received following a fast on Day 1 and 3 mg/kg oxfendazole following a high fat meal on Day 8</description>
        </group>
        <group group_id="P5">
          <title>Arm 4B: 3 mg/kg Oxfendazole High Fat Meal First, Then Fasted</title>
          <description>3 mg/kg oxfendazole orally, one dose received following a high fat meal on Day 1 and 3 mg/kg oxfendazole following a fast on Day 8</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>First Intervention - 10/7 Days Follow-up</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="6"/>
                <participants group_id="P5" count="6"/>
              </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="6"/>
                <participants group_id="P5" count="6"/>
              </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_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Second Intervention - 7 Days Follow-up</title>
          <milestone_list>
            <milestone>
              <title>STARTED</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="6"/>
                <participants group_id="P5" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>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="6"/>
                <participants group_id="P5" count="6"/>
              </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_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All subjects are included in the analysis population</population>
      <group_list>
        <group group_id="B1">
          <title>Arm 1: 3 mg/kg Oxfendazole for 5 Days</title>
          <description>Participants received 3 mg/kg oxfendazole orally once daily for 5 days</description>
        </group>
        <group group_id="B2">
          <title>Arm 2: 7.5 mg/kg Oxfendazole for 5 Days</title>
          <description>Participants received 7.5 mg/kg oxfendazole orally once daily for 5 days</description>
        </group>
        <group group_id="B3">
          <title>Arm 3: 15 mg/kg Oxfendazole for 5 Days</title>
          <description>Participants received 15 mg/kg oxfendazole orally once daily for 5 days</description>
        </group>
        <group group_id="B4">
          <title>Arm 4A: 3 mg/kg Oxfendazole Fasted First, Then High Fat Meal</title>
          <description>3 mg/kg oxfendazole orally, one dose received following a fast on Day 1 and 3 mg/kg oxfendazole following a high fat meal on Day 8</description>
        </group>
        <group group_id="B5">
          <title>Arm 4B: 3 mg/kg Oxfendazole High Fat Meal First, Then Fasted</title>
          <description>3 mg/kg oxfendazole orally, one dose received following a high fat meal on Day 1 and 3 mg/kg oxfendazole following a fast on Day 8</description>
        </group>
        <group group_id="B6">
          <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="6"/>
            <count group_id="B5" value="6"/>
            <count group_id="B6" value="36"/>
          </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_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="6"/>
                    <measurement group_id="B5" value="6"/>
                    <measurement group_id="B6" value="36"/>
                  </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_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="29.3" spread="9.1"/>
                    <measurement group_id="B2" value="27.1" spread="6.1"/>
                    <measurement group_id="B3" value="30.1" spread="4.4"/>
                    <measurement group_id="B4" value="27.7" spread="5.6"/>
                    <measurement group_id="B5" value="32.2" spread="9.4"/>
                    <measurement group_id="B6" value="29.2" spread="6.9"/>
                  </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="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="4"/>
                    <measurement group_id="B6" value="25"/>
                  </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="1"/>
                    <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="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</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="4"/>
                    <measurement group_id="B5" value="6"/>
                    <measurement group_id="B6" value="32"/>
                  </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="0"/>
                  </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_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" 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_list>
                </category>
                <category>
                  <title>Black or African American</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="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="6"/>
                    <measurement group_id="B6" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</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="1"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="2"/>
                  </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="0"/>
                  </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="6"/>
                    <measurement group_id="B5" value="6"/>
                    <measurement group_id="B6" value="36"/>
                  </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 (AEs) Related to Oxfendazole for Arms 1, 2, and 3</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>Day 1 through Day 10</time_frame>
        <population>All participants are included in the analysis population.</population>
        <group_list>
          <group group_id="O1">
            <title>Arm 1: 3 mg/kg Oxfendazole for 5 Days</title>
            <description>Participants received 3 mg/kg oxfendazole orally once daily for 5 days</description>
          </group>
          <group group_id="O2">
            <title>Arm 2: 7.5 mg/kg Oxfendazole for 5 Days</title>
            <description>Participants received 7.5 mg/kg oxfendazole orally once daily for 5 days</description>
          </group>
          <group group_id="O3">
            <title>Arm 3: 15 mg/kg Oxfendazole for 5 Days</title>
            <description>Participants received 15 mg/kg oxfendazole orally once daily for 5 days</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Reporting Adverse Events (AEs) Related to Oxfendazole for Arms 1, 2, and 3</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_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Subjects Reporting Adverse Events (AEs) Related to Oxfendazole for Arm 4</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>Day 1 through Day 14</time_frame>
        <population>All participants are included in the analysis population.</population>
        <group_list>
          <group group_id="O1">
            <title>Arm 4: 3 mg/kg Oxfendazole, Post Fast</title>
            <description>3 mg/kg oxfendazole orally, one dose received following a fast on Day 1 or on Day 8</description>
          </group>
          <group group_id="O2">
            <title>Arm 4: 3 mg/kg Oxfendazole, Post Fed</title>
            <description>3 mg/kg oxfendazole orally, one dose received following a high fat meal on Day 1 or on Day 8</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Reporting Adverse Events (AEs) Related to Oxfendazole for Arm 4</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="12"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Area Under the Concentration Time-curve for a Single Dosing Interval (AUCtau) of Oxfendazole for Arm 1, 2 and 3</title>
        <description>AUCtau was defined as the total area under the concentration-time curve from dosing to the end of the 24-hour dosing interval for Dose 1 and Dose 5. AUCtau was calculated using the Linear Up Log Down calculation method.</description>
        <time_frame>0, 0.5, 1, 2, 3, 4, 6, 9, 12, 24 hours post-dose on day 1 and 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 24, 72, 120 hours post-dose on day 5</time_frame>
        <population>All participants are included in the analysis population.</population>
        <group_list>
          <group group_id="O1">
            <title>Arm 1: 3 mg/kg Oxfendazole for 5 Days</title>
            <description>Participants received 3 mg/kg oxfendazole orally once daily for 5 days</description>
          </group>
          <group group_id="O2">
            <title>Arm 2: 7.5 mg/kg Oxfendazole for 5 Days</title>
            <description>Participants received 7.5 mg/kg oxfendazole orally once daily for 5 days</description>
          </group>
          <group group_id="O3">
            <title>Arm 3: 15 mg/kg Oxfendazole for 5 Days</title>
            <description>Participants received 15 mg/kg oxfendazole orally once daily for 5 days</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Concentration Time-curve for a Single Dosing Interval (AUCtau) of Oxfendazole for Arm 1, 2 and 3</title>
          <description>AUCtau was defined as the total area under the concentration-time curve from dosing to the end of the 24-hour dosing interval for Dose 1 and Dose 5. AUCtau was calculated using the Linear Up Log Down calculation method.</description>
          <population>All participants 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_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Dose 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30200" spread="66.7"/>
                    <measurement group_id="O2" value="52500" spread="73.9"/>
                    <measurement group_id="O3" value="71800" spread="50.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dose 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38200" spread="33.1"/>
                    <measurement group_id="O2" value="65700" spread="34.5"/>
                    <measurement group_id="O3" value="69600" spread="28.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Area Under the Concentration Time-curve to the Time of Last Measured Concentration (AUClast) of Oxfendazole for Arm 4</title>
        <description>AUClast was defined as the area under the concentration-time curve from dosing to the time of the last measured concentration of that dosing period greater than the lower limit of quantification of the bioanalytical assay. AUClast was calculated using the Linear Up Log Down calculation method.</description>
        <time_frame>0, 0.5, 1, 2, 3, 4, 6, 9, 12, 24 hours post-dose</time_frame>
        <population>All participants are included in the analysis population.</population>
        <group_list>
          <group group_id="O1">
            <title>Arm 4: 3 mg/kg Oxfendazole, Fed/Fasted</title>
            <description>3 mg/kg oxfendazole orally, one dose received following a fast (n=6) or high fat meal (n=6) on Day 1 and crossed over to opposite arm to receive drug following high fat meal or fast on Day 8</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Concentration Time-curve to the Time of Last Measured Concentration (AUClast) of Oxfendazole for Arm 4</title>
          <description>AUClast was defined as the area under the concentration-time curve from dosing to the time of the last measured concentration of that dosing period greater than the lower limit of quantification of the bioanalytical assay. AUClast was calculated using the Linear Up Log Down calculation method.</description>
          <population>All participants 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="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Fed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58900" spread="25.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fasted</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31600" spread="38.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Maximum Observed Concentration (Cmax) of Oxfendazole in Plasma for Arms 1, 2, and 3</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, 0.5, 1, 2, 3, 4, 6, 9, 12, 24 hours post-dose on day 1 and 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 24, 72, 120 hours post-dose on day 5</time_frame>
        <population>All participants are included in the analysis population.</population>
        <group_list>
          <group group_id="O1">
            <title>Arm 1: 3 mg/kg Oxfendazole for 5 Days</title>
            <description>Participants received 3 mg/kg oxfendazole orally once daily for 5 days</description>
          </group>
          <group group_id="O2">
            <title>Arm 2: 7.5 mg/kg Oxfendazole for 5 Days</title>
            <description>Participants received 7.5 mg/kg oxfendazole orally once daily for 5 days</description>
          </group>
          <group group_id="O3">
            <title>Arm 3: 15 mg/kg Oxfendazole for 5 Days</title>
            <description>Participants received 15 mg/kg oxfendazole orally once daily for 5 days</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Observed Concentration (Cmax) of Oxfendazole in Plasma for Arms 1, 2, and 3</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 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_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Dose 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2960" spread="42.7"/>
                    <measurement group_id="O2" value="4160" spread="59.6"/>
                    <measurement group_id="O3" value="5990" spread="53.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dose 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3500" spread="16.3"/>
                    <measurement group_id="O2" value="5980" spread="17.8"/>
                    <measurement group_id="O3" value="6000" spread="28.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Maximum Observed Concentration (Cmax) of Oxfendazole in Plasma for Arm 4</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, 0.5, 1, 2, 3, 4, 6, 9, 12, 24 hours post-dose</time_frame>
        <population>All participants are included in the analysis population.</population>
        <group_list>
          <group group_id="O1">
            <title>Arm 4: 3 mg/kg Oxfendazole, Fed/Fasted</title>
            <description>3 mg/kg oxfendazole orally, one dose received following a fast (n=6) or high fat meal (n=6) on Day 1 and crossed over to opposite arm to receive drug following high fat meal or fast on Day 8</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Observed Concentration (Cmax) of Oxfendazole in Plasma for Arm 4</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 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="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Fed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4500" spread="19.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fasted</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3010" spread="40.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Terminal Elimination Half-life (t1/2) of Oxfendazole for Arms 1, 2, and 3</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, 0.5, 1, 2, 3, 4, 6, 9, 12, 24 hours post-dose on day 1 and 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 24, 72, 120 hours post-dose on day 5</time_frame>
        <population>All participants are included in the analysis population.</population>
        <group_list>
          <group group_id="O1">
            <title>Arm 1: 3 mg/kg Oxfendazole for 5 Days</title>
            <description>Participants received 3 mg/kg oxfendazole orally once daily for 5 days</description>
          </group>
          <group group_id="O2">
            <title>Arm 2: 7.5 mg/kg Oxfendazole for 5 Days</title>
            <description>Participants received 7.5 mg/kg oxfendazole orally once daily for 5 days</description>
          </group>
          <group group_id="O3">
            <title>Arm 3: 15 mg/kg Oxfendazole for 5 Days</title>
            <description>Participants received 15 mg/kg oxfendazole orally once daily for 5 days</description>
          </group>
        </group_list>
        <measure>
          <title>Terminal Elimination Half-life (t1/2) of Oxfendazole for Arms 1, 2, and 3</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 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_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Dose 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.98" spread="1.47"/>
                    <measurement group_id="O2" value="8.54" spread="3.62"/>
                    <measurement group_id="O3" value="8.35" spread="0.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dose 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.47" spread="2.34"/>
                    <measurement group_id="O2" value="11.00" spread="3.39"/>
                    <measurement group_id="O3" value="12.00" spread="2.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Terminal Elimination Half-life (t1/2) of Oxfendazole for Arm 4</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, 0.5, 1, 2, 3, 4, 6, 9, 12, 24 hours post-dose</time_frame>
        <population>All participants are included in the analysis population.</population>
        <group_list>
          <group group_id="O1">
            <title>Arm 4: 3 mg/kg Oxfendazole, Fed/Fasted</title>
            <description>3 mg/kg oxfendazole orally, one dose received following a fast (n=6) or high fat meal (n=6) on Day 1 and crossed over to opposite arm to receive drug following high fat meal or fast on Day 8</description>
          </group>
        </group_list>
        <measure>
          <title>Terminal Elimination Half-life (t1/2) of Oxfendazole for Arm 4</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 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="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Fed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.05" spread="0.776"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fasted</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.65" spread="1.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time of Maximum Observed Concentration (Tmax) of Oxfendazole for Arms 1, 2, and 3</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, 0.5, 1, 2, 3, 4, 6, 9, 12, 24 hours post-dose on day 1 and 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 24, 72, 120 hours post-dose on day 5</time_frame>
        <population>All participants are included in the analysis population.</population>
        <group_list>
          <group group_id="O1">
            <title>Arm 1: 3 mg/kg Oxfendazole for 5 Days</title>
            <description>Participants received 3 mg/kg oxfendazole orally once daily for 5 days</description>
          </group>
          <group group_id="O2">
            <title>Arm 2: 7.5 mg/kg Oxfendazole for 5 Days</title>
            <description>Participants received 7.5 mg/kg oxfendazole orally once daily for 5 days</description>
          </group>
          <group group_id="O3">
            <title>Arm 3: 15 mg/kg Oxfendazole for 5 Days</title>
            <description>Participants received 15 mg/kg oxfendazole orally once daily for 5 days</description>
          </group>
        </group_list>
        <measure>
          <title>Time of Maximum Observed Concentration (Tmax) of Oxfendazole for Arms 1, 2, and 3</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 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_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Dose 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.96" lower_limit="1.83" upper_limit="8.55"/>
                    <measurement group_id="O2" value="2.02" lower_limit="0.983" upper_limit="8.55"/>
                    <measurement group_id="O3" value="2.56" lower_limit="0.983" upper_limit="8.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dose 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.92" lower_limit="1.02" upper_limit="3.00"/>
                    <measurement group_id="O2" value="2.02" lower_limit="1.78" upper_limit="3.08"/>
                    <measurement group_id="O3" value="2.49" lower_limit="0.917" upper_limit="3.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time of Maximum Observed Concentration (Tmax) of Oxfendazole for Arm 4</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, 0.5, 1, 2, 3, 4, 6, 9, 12, 24 hours post-dose</time_frame>
        <population>All participants are included in the analysis population.</population>
        <group_list>
          <group group_id="O1">
            <title>Arm 4: 3 mg/kg Oxfendazole, Fed/Fasted</title>
            <description>3 mg/kg oxfendazole orally, one dose received following a fast (n=6) or high fat meal (n=6) on Day 1 and crossed over to opposite arm to receive drug following high fat meal or fast on Day 8</description>
          </group>
        </group_list>
        <measure>
          <title>Time of Maximum Observed Concentration (Tmax) of Oxfendazole for Arm 4</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 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="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Fed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.9" lower_limit="3.9" upper_limit="11.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fasted</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.99" lower_limit="1" upper_limit="2.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>AEs were collected from the time of receipt of study drug on Day 1 through the final study visit (approximately 10 or 14 days after receipt of study product).</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Arm 1: 3 mg/kg Oxfendazole for 5 Days</title>
          <description>Participants received 3 mg/kg oxfendazole orally once daily for 5 days</description>
        </group>
        <group group_id="E2">
          <title>Arm 2: 7.5 mg/kg Oxfendazole for 5 Days</title>
          <description>Participants received 7.5 mg/kg oxfendazole orally once daily for 5 days</description>
        </group>
        <group group_id="E3">
          <title>Arm 3: 15 mg/kg Oxfendazole for 5 Days</title>
          <description>Participants received 15 mg/kg oxfendazole orally once daily for 5 days</description>
        </group>
        <group group_id="E4">
          <title>Arm 4: 3 mg/kg Oxfendazole, Post Fast</title>
          <description>3 mg/kg oxfendazole orally, one dose received following a fast on Day 1 or on Day 8</description>
        </group>
        <group group_id="E5">
          <title>Arm 4: 3 mg/kg Oxfendazole, Post Fed</title>
          <description>3 mg/kg oxfendazole orally, one dose received following a high fat meal on Day 1 or on Day 8</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="12"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="12"/>
              </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="12"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA (21.0)</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="3" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="12"/>
              </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="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="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Dyspepsia</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="12"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </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="1" subjects_affected="1" 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="12"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Vessel Puncture Site Haemorrhage</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="12"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Electrocardiogram QT Prolonged</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="12"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased Appetite</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="12"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</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="12"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" 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="12"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Oropharyngial 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="12"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </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/NCT03035760
org study id: 16-0005
secondary id: HHSN272201300020I
nct id: NCT03035760
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
This Phase I study is an open label multiple ascending dose evaluation of the safety and PK
      of oxfendazole (3, 7.5, or 15 mg/kg) given orally daily to healthy adult men and nonpregnant
      women aged 18-45 followed by a single dose cross over trial evaluating the safety and
      pharmacokinetics of a single dose of oxfendazole (3 mg/kg) given following an 8 hour fast or
      following a high fat meal. The study duration will be approximately 12 months with each
      subject participation lasting approximately 6 weeks. In the multiple ascending dose
      evaluation, between 8 and 24 subjects will be enrolled; each dose group will be comprised of
      eight volunteers. To enhance safety, one sentinel subject will be dosed for five days and
      monitored for 7 days from the time of the first dose for predefined adverse events. If there
      are no predefined safety events, a second sentinel subject will be enrolled and followed for
      a total of 7 days. If there are no predefined safety signals identified for either of these
      two sentinel subjects, the remaining subjects in the group will be enrolled. After all eight
      subjects have completed the 10 day follow up period, an electronic safety review of the
      electronic data will be performed. If none of the predefined safety events have occurred DMID
      will approve enrollment into the second dose group (7.5 mg/kg oxfendazole daily x 5 days) and
      will be monitored for a total of 7 days each for predefined adverse events prior to enrolling
      the remaining subjects in the group. After the 10 day follow up period has been completed for
      group 2, an electronic safety review will be completed and if no predefined events have
      occurred two sequential subjects (one at a time with 7 days between each subject) will be
      enrolled into the third dose group (15 mg/kg oxfendazole daily x 5 days) and will be
      monitored for a total of 7 days each for predefined safety events prior to enrolling the
      remaining subjects in the group. In the food effects evaluation, 12 subjects will be enrolled
      into the single dose cross over group where half of the subjects will initially receive a
      single dose of 3 mg/kg of oxfendazole following an 8 hour fast and the other half will
      receive a single dose of 3 mg/kg of oxfendazole following a high fat meal. Subjects will then
      cross over to receive a single dose following a high fat breakfast or fasting period (water
      is permitted). All subjects will have received a dose of oxfendazole following both a fasting
      period and a meal. The primary objectives are: 1) To assess the safety of oxfendazole
      administered daily for five days; and 2) To assess the safety of oxfendazole administered as
      a single dose with or without food.
This Phase I study is an open label multiple ascending dose evaluation of the safety and PK
      of oxfendazole (3, 7.5, or 15 mg/kg) given orally daily to healthy adult men and nonpregnant
      women aged 18-45 followed by a single dose cross over trial evaluating the safety and
      pharmacokinetics of a single dose of oxfendazole (3 mg/kg) given following an 8 hour fast or
      following a high fat meal. The study duration will be approximately 12 months with each
      subject participation lasting approximately 6 weeks. In the multiple ascending dose
      evaluation, between 8 and 24 subjects will be enrolled; each dose group will be comprised of
      eight volunteers. To enhance safety, one sentinel subject will be dosed for five days and
      monitored for 7 days from the time of the first dose for predefined adverse events. If there
      are no predefined safety events, a second sentinel subject will be enrolled and followed for
      a total of 7 days. If there are no predefined safety signals identified for either of these
      two sentinel subjects, the remaining subjects in the group will be enrolled. After all eight
      subjects have completed the 10 day follow up period, an electronic safety review of the
      electronic data will be performed. If none of the predefined safety events have occurred DMID
      will approve enrollment into the second dose group (7.5 mg/kg oxfendazole daily x 5 days) and
      will be monitored for a total of 7 days each for predefined adverse events prior to enrolling
      the remaining subjects in the group. After the 10 day follow up period has been completed for
      group 2, an electronic safety review will be completed and if no predefined events have
      occurred two sequential subjects (one at a time with 7 days between each subject) will be
      enrolled into the third dose group (15 mg/kg oxfendazole daily x 5 days) and will be
      monitored for a total of 7 days each for predefined safety events prior to enrolling the
      remaining subjects in the group. In the food effects evaluation, 12 subjects will be enrolled
      into the single dose cross over group where half of the subjects will initially receive a
      single dose of 3 mg/kg of oxfendazole following an 8 hour fast and the other half will
      receive a single dose of 3 mg/kg of oxfendazole following a high fat meal. Subjects will then
      cross over to receive a single dose following a high fat breakfast or fasting period (water
      is permitted). All subjects will have received a dose of oxfendazole following both a fasting
      period and a meal. The primary objectives are: 1) To assess the safety of oxfendazole
      administered daily for five days; and 2) To assess the safety of oxfendazole administered as
      a single dose with or without food. The secondary objectives are: 1) To define the multi-dose
      kinetics of oxfendazole; and 2) To determine the effect of food on the kinetics of
      oxfendazole.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Subjects Reporting Adverse Events (AEs) Related to Oxfendazole for Arms 1, 2, and 3
time frame: Day 1 through Day 10
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: Number of Subjects Reporting Adverse Events (AEs) Related to Oxfendazole for Arm 4
time frame: Day 1 through Day 14
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 for a Single Dosing Interval (AUCtau) of Oxfendazole for Arm 1, 2 and 3
time frame: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 24 hours post-dose on day 1 and 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 24, 72, 120 hours post-dose on day 5
description: AUCtau was defined as the total area under the concentration-time curve from dosing to the end of the 24-hour dosing interval for Dose 1 and Dose 5. AUCtau was calculated using the Linear Up Log Down calculation method.
measure: Area Under the Concentration Time-curve to the Time of Last Measured Concentration (AUClast) of Oxfendazole for Arm 4
time frame: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 24 hours post-dose
description: AUClast was defined as the area under the concentration-time curve from dosing to the time of the last measured concentration of that dosing period greater than the lower limit of quantification of the bioanalytical assay. AUClast was calculated using the Linear Up Log Down calculation method.
measure: Maximum Observed Concentration (Cmax) of Oxfendazole in Plasma for Arms 1, 2, and 3
time frame: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 24 hours post-dose on day 1 and 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 24, 72, 120 hours post-dose on day 5
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: Maximum Observed Concentration (Cmax) of Oxfendazole in Plasma for Arm 4
time frame: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 24 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: Terminal Elimination Half-life (t1/2) of Oxfendazole for Arms 1, 2, and 3
time frame: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 24 hours post-dose on day 1 and 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 24, 72, 120 hours post-dose on day 5
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: Terminal Elimination Half-life (t1/2) of Oxfendazole for Arm 4
time frame: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 24 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 for Arms 1, 2, and 3
time frame: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 24 hours post-dose on day 1 and 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 24, 72, 120 hours post-dose on day 5
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: Time of Maximum Observed Concentration (Tmax) of Oxfendazole for Arm 4
time frame: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 24 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.
arm group label: 1
arm group type: Experimental
description: 3 mg/kg orally once daily for 5 days (n = 8)
arm group label: 2
arm group type: Experimental
description: 7.5 mg/kg orally once daily for 5 days (n = 8)
arm group label: 3
arm group type: Experimental
description: 15 mg/kg orally once daily for 5 days (n = 8)
arm group label: 4
arm group type: Experimental
description: 3 mg/kg orally, one dose received following a fast (n=6) or high fat meal (n=6) on Day 1 and crossed over to opposite arm to receive drug following high fat meal or fast on Day 8
intervention type: Drug
intervention name: Oxfendazole
description: methyl-5 (6)-phenylsulfiyl-2-benzimidazole carbamate, is a broad spectrum benzimidazole antihelminthic. It is the sulphoxide metabolite of fenbendazole.
arm group label: 1
arm group label: 2
arm group label: 3
arm group label: 4
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: Helminthiasis
mesh term: Oxfendazole
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 