xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06025318</url>
    </required_header>
    <id_info>
      <org_study_id>VRS-23-001</org_study_id>
      <nct_id>NCT06025318</nct_id>
    </id_info>
    <brief_title>An Evaluation of the Effect of Food on the PK of a Novel PanCytoVir™ Suspension (100mg/ml), in Healthy, Adult Volunteers</brief_title>
    <official_title>An Open-label, Balanced, Randomized, Two-period, Crossover, Single Dose Study to Compare the Bioavailability of PanCytoVir™ Oral Suspension (100mg/ml), in Healthy, Adult, Human Subjects Under Fed and Fasting Conditions</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>TrippBio, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>TrippBio, Inc.</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is an open-label, balanced, randomized, two-period, crossover, single dose study to&#xD;
        compare the relative bioavailability in normal healthy, adult, human subjects under Fed and&#xD;
        Fasting conditions. Subjects will receive a single oral dose of probenecid oral suspension&#xD;
        (100 mg/mL) under fed and fasted conditions.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">November 2023</completion_date>
    <primary_completion_date type="Anticipated">November 2023</primary_completion_date>
    <phase>Phase 1</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Crossover Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>To assess food effect on PanCytoVir™ in healthy, adult, human subjects as assessed by Cmax</measure>
      <time_frame>7 days</time_frame>
      <description>The drug concentration in plasma assessed by Cmax</description>
    </primary_outcome>
    <primary_outcome>
      <measure>To assess food effect on PanCytoVir™ in healthy, adult, human subjects as assessed by AUC</measure>
      <time_frame>7 days</time_frame>
      <description>The drug concentration in plasma assessed by AUC</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>the Incidence rates of AEs, TEAEs and Serious Adverse Events (SAEs)</measure>
      <time_frame>7 days</time_frame>
      <description>Numbers and incidence rates of AEs, TEAEs and Serious Adverse Events (SAEs) will be tabulated using available version of Medical Dictionary for Regulatory Activities (MedDRA) preferred term (PT), system organ class (SOC), severity and relationship. A patient having the same AE will be counted only once in calculating frequency while patient having same AE with different start date then both will be considered for calculating frequency. If AE is with same start date but different criteria (severity, relationship to study medication and outcome), worst case/latest case (whichever applicable) will be considered. Incidence of AEs will be summarized with count (%).</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">14</enrollment>
    <condition>Relative Bioavailability</condition>
    <arm_group>
      <arm_group_label>PanCytoVir™ 1000 mg fasted</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Single oral dose of PanCytoVir™ 1000 mg (100 mg/mL suspension) following an overnight fast</description>
    </arm_group>
    <arm_group>
      <arm_group_label>PanCytoVir™ 1000 mg fed</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Single oral dose of PanCytoVir™ 1000 mg (100 mg/mL suspension) following a standard, high-fat, high-calorie breakfast</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>PanCytoVir™</intervention_name>
      <description>PanCytoVir™ 100 mg/mL oral suspension</description>
      <arm_group_label>PanCytoVir™ 1000 mg fasted</arm_group_label>
      <arm_group_label>PanCytoVir™ 1000 mg fed</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Normal healthy adult human subjects.&#xD;
  &#xD;
            2. Subjects who are willing to participate and give informed consent&#xD;
  &#xD;
            3. Subjects who are ≥ 18 years of age to ≤ 45 years of age and have a Body Mass Index&#xD;
               between ≥18.5 to ≤ 30.0 kg/m2 extremes included, with weight of at least 50 kg.&#xD;
  &#xD;
            4. Subjects with normal findings as determined by baseline history, physical examination&#xD;
               and vital sign examination (blood pressure, pulse rate, respiration rate and body&#xD;
               temperature).&#xD;
  &#xD;
            5. Subjects with clinically acceptable findings as determined by haemogram, biochemistry,&#xD;
               urine analysis, 12 lead ECG and chest X-ray.&#xD;
  &#xD;
            6. Willingness to follow the protocol requirements especially abstaining from xanthine&#xD;
               containing food or beverages (chocolates, tea, coffee or cola drinks) or grapefruit&#xD;
               juice, any alcoholic products, the use of cigarettes and the use of tobacco products&#xD;
               for 72.00 hours prior to dosing until after the last blood sample collection in each&#xD;
               study period and adherence to food, fluid and posture restrictions.&#xD;
  &#xD;
            7. No history of significant alcoholism.&#xD;
  &#xD;
            8. Subject who have an estimated glomerular filtration rate (eGFR) value is &gt;60ml/min.&#xD;
  &#xD;
            9. Found negative in Alcohol test.&#xD;
  &#xD;
           10. Found negative in urine test for drug abuse [Benzodiazepines, Barbiturates, Morphine,&#xD;
               Cocaine, Amphetamines and Tetrahydrocannabinol (THC)].&#xD;
  &#xD;
           11. Non-smokers, ex-smokers and moderate smokers will be included. &quot;Moderate smokers are&#xD;
               defined as someone smoking 10 cigarettes or less per day, ex-smokers are someone who&#xD;
               completely stopped smoking for at least 3 months.&quot;&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. History of allergic responses or hypersensitivity to Probenecid or other related&#xD;
               drugs, or any of its ingredients.&#xD;
  &#xD;
            2. Requiring medication for any ailment having enzyme-modifying activity in the previous&#xD;
               21 days, prior to dosing day.&#xD;
  &#xD;
            3. Subjects who have taken prescription medications or over-the-counter products&#xD;
               (including vitamins and minerals) within 14 days prior to administration of study drug&#xD;
  &#xD;
            4. Any medical or surgical conditions, which might significantly interfere with the&#xD;
               functioning of gastrointestinal tract, blood-forming organs etc.&#xD;
  &#xD;
            5. History of cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological,&#xD;
               metabolic, haematological, gastrointestinal, endocrine, immunological or psychiatric&#xD;
               diseases.&#xD;
  &#xD;
            6. Participation in a clinical drug study or bioequivalence study 90 days prior to period&#xD;
               I dosing of the present study.&#xD;
  &#xD;
            7. History of malignancy or other serious diseases.&#xD;
  &#xD;
            8. Blood donation 90 days prior to period I dosing of the present study.&#xD;
  &#xD;
            9. Subjects with positive HIV tests, HBsAg or Hepatitis-C tests.&#xD;
  &#xD;
           10. History of problem in swallowing tablets/capsules/ Suspension.&#xD;
  &#xD;
           11. Any contraindication to blood sampling.&#xD;
  &#xD;
           12. Female subjects found positive serum (β) Beta- hCG (Human Chorionic Gonadotropin)&#xD;
               test.&#xD;
  &#xD;
           13. Lactating women (currently breast feeding).&#xD;
  &#xD;
           14. Female subjects not confirming to using birth control measures, from the date of&#xD;
               screening until the completion of the study. Abstinence, barrier methods (condom,&#xD;
               diaphragm, etc.) are acceptable.&#xD;
  &#xD;
           15. Use of hormonal contraceptives either oral or implants.&#xD;
  &#xD;
           16. History of urinary retention, gastric retention and other severe decreased&#xD;
               gastrointestinal motility conditions, uncontrolled narrow-angle glaucoma.&#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>
    <overall_official>
      <last_name>David E Martin, PharmD</last_name>
      <role>Study Director</role>
      <affiliation>TrippBio, Inc.</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>David E. Martin, PharmD</last_name>
      <phone>3015381878</phone>
      <email>davidmartin@trippbio.com</email>
    </overall_contact>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 24, 2023</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Plans are currently being developed</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06025318
  org study id: VRS-23-001
  nct id: NCT06025318
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  This is an open-label, balanced, randomized, two-period, crossover, single dose study to
        compare the relative bioavailability in normal healthy, adult, human subjects under Fed and
        Fasting conditions. Subjects will receive a single oral dose of probenecid oral suspension
        (100 mg/mL) under fed and fasted conditions.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: To assess food effect on PanCytoVir™ in healthy, adult, human subjects as assessed by Cmax
  time frame: 7 days
  description: The drug concentration in plasma assessed by Cmax
  measure: To assess food effect on PanCytoVir™ in healthy, adult, human subjects as assessed by AUC
  time frame: 7 days
  description: The drug concentration in plasma assessed by AUC
  measure: the Incidence rates of AEs, TEAEs and Serious Adverse Events (SAEs)
  time frame: 7 days
  description: Numbers and incidence rates of AEs, TEAEs and Serious Adverse Events (SAEs) will be tabulated using available version of Medical Dictionary for Regulatory Activities (MedDRA) preferred term (PT), system organ class (SOC), severity and relationship. A patient having the same AE will be counted only once in calculating frequency while patient having same AE with different start date then both will be considered for calculating frequency. If AE is with same start date but different criteria (severity, relationship to study medication and outcome), worst case/latest case (whichever applicable) will be considered. Incidence of AEs will be summarized with count (%).
  arm group label: PanCytoVir™ 1000 mg fasted
  arm group type: Experimental
  description: Single oral dose of PanCytoVir™ 1000 mg (100 mg/mL suspension) following an overnight fast
  arm group label: PanCytoVir™ 1000 mg fed
  arm group type: Experimental
  description: Single oral dose of PanCytoVir™ 1000 mg (100 mg/mL suspension) following a standard, high-fat, high-calorie breakfast
  intervention type: Drug
  intervention name: PanCytoVir™
  description: PanCytoVir™ 100 mg/mL oral suspension
  arm group label: PanCytoVir™ 1000 mg fasted
  arm group label: PanCytoVir™ 1000 mg fed
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 45 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: David E Martin, PharmD
  role: Study Director
  affiliation: TrippBio, Inc.
  last name: David E. Martin, PharmD
  phone: 3015381878
  email: davidmartin@trippbio.com
  responsible party type: Sponsor
  sharing ipd: No
  ipd description: Plans are currently being developed