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/NCT06025344</url>
    </required_header>
    <id_info>
      <org_study_id>VRS-23-002</org_study_id>
      <nct_id>NCT06025344</nct_id>
    </id_info>
    <brief_title>A Relative Bioavailability Study With a Novel PanCytoVir™ Oral Suspension (100 mg/ml)</brief_title>
    <official_title>A Single Dose Oral Bioavailability Study of PanCytoVir™ Oral Suspension (100 mg/ml) 1000 mg Versus Probenecid 500 mg Tablets, 1000 mg (2 X 500 mg) in Healthy, Adult, Human Subjects Under 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>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        An open-label, balanced, randomized, two-treatment, two-sequence, two-period, crossover,&#xD;
        single dose oral relative bioavailability study of a novel PanCytoVir™ oral suspension (100&#xD;
        mg/mL) versus probenecid 500 mg tablets in normal healthy, adult, human subjects under&#xD;
        fasting 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">October 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>Bioavailability comparison using Cmax</measure>
      <time_frame>7 days</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Bioavailability comparison using AUC</measure>
      <time_frame>7 days</time_frame>
    </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 (100 mg/mL)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>PanCytoVir™ oral suspension (100 mg/mL)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Probenecid 1000 mg (2x500 mg tablets)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Probenecid 500 mg tablets</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>PanCytoVir™ 100 mg/mL oral suspension</intervention_name>
      <description>Single oral dose of 1000 mg (100 mg/mL) under fasted conditions</description>
      <arm_group_label>PanCytoVir™ 1000 mg (100 mg/mL)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Probenecid 500 mg</intervention_name>
      <description>Single oral dose of 1000 mg under fasted conditions</description>
      <arm_group_label>Probenecid 1000 mg (2x500 mg tablets)</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 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&#xD;
               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>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Probenecid</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Plans are currently under development</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/NCT06025344
  org study id: VRS-23-002
  nct id: NCT06025344
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  An open-label, balanced, randomized, two-treatment, two-sequence, two-period, crossover,
        single dose oral relative bioavailability study of a novel PanCytoVir™ oral suspension (100
        mg/mL) versus probenecid 500 mg tablets in normal healthy, adult, human subjects under
        fasting conditions.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Bioavailability comparison using Cmax
  time frame: 7 days
  measure: Bioavailability comparison using AUC
  time frame: 7 days
  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 (100 mg/mL)
  arm group type: Experimental
  description: PanCytoVir™ oral suspension (100 mg/mL)
  arm group label: Probenecid 1000 mg (2x500 mg tablets)
  arm group type: Experimental
  description: Probenecid 500 mg tablets
  intervention type: Drug
  intervention name: PanCytoVir™ 100 mg/mL oral suspension
  description: Single oral dose of 1000 mg (100 mg/mL) under fasted conditions
  arm group label: PanCytoVir™ 1000 mg (100 mg/mL)
  intervention type: Drug
  intervention name: Probenecid 500 mg
  description: Single oral dose of 1000 mg under fasted conditions
  arm group label: Probenecid 1000 mg (2x500 mg tablets)
  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
  mesh term: Probenecid
  sharing ipd: No
  ipd description: Plans are currently under development