<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/NCT04494178</url>
  </required_header>
  <id_info>
    <org_study_id>G-Fum_01</org_study_id>
    <nct_id>NCT04494178</nct_id>
  </id_info>
  <brief_title>G-PUR® for Reduced Dietary Fumonisin Bioavailability</brief_title>
  <official_title>A Randomized, Placebo-controlled, Double-blind, Cross-over Study to Evaluate the Effect of G-PUR® on Dietary Fumonisin Bioavailability</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Glock Health, Science and Research GmbH</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Glock Health, Science and Research GmbH</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This prospective, placebo-controlled, randomized, monocentric, double-blind, crossover study&#xD;
      in healthy volunteers aims to assess the effect of a single dose of 2 g G-PUR® on&#xD;
      bioavailability of dietary fumonisin and to evaluate safety and tolerability.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Several analytical laboratories failed to develop and validate a suitable assay of urine&#xD;
    fumonisin (the primary endpoint) up to date. Because of missing alternatives for an analytical&#xD;
    laboratory the objective of the study cannot be met.&#xD;
  </why_stopped>
  <start_date type="Actual">August 18, 2020</start_date>
  <completion_date type="Actual">November 4, 2020</completion_date>
  <primary_completion_date type="Actual">November 4, 2020</primary_completion_date>
  <phase>N/A</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>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The bioavailability of fumonisin is estimated based on the concentration of urinary biomarkers FB1 and FB2</measure>
    <time_frame>24 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of (serious) adverse device effects</measure>
    <time_frame>19 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urinary biomarkers FB1 and FB2 (separately and sum of FB1 and FB2)</measure>
    <time_frame>24 hours</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">7</enrollment>
  <condition>Reduction of Dietary Fumonisin Bioavailability</condition>
  <arm_group>
    <arm_group_label>2.0g G-PUR® oral - Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo - 2.0g G-PUR® oral</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>2.0g G-PUR®</intervention_name>
    <description>Oral administration (Intervention period I)</description>
    <arm_group_label>2.0g G-PUR® oral - Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>2.0g G-PUR®</intervention_name>
    <description>Oral administration (Intervention period II)</description>
    <arm_group_label>Placebo - 2.0g G-PUR® oral</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Intervention period I</description>
    <arm_group_label>Placebo - 2.0g G-PUR® oral</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Intervention period II</description>
    <arm_group_label>2.0g G-PUR® oral - Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy male and female subjects&#xD;
&#xD;
          2. Age 18-55 years&#xD;
&#xD;
          3. BMI 17-27&#xD;
&#xD;
          4. Subjects are in good clinical and mental health as established by medical history and&#xD;
             physical examination&#xD;
&#xD;
          5. Subject understands the scope of the study and agrees to strictly adhere to the study&#xD;
             related diet plan&#xD;
&#xD;
          6. Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnancy or breastfeeding.&#xD;
&#xD;
          2. Lack of willingness or capacity to co-operate appropriately&#xD;
&#xD;
          3. Regular use of medications in the previous 2 months (except oral contraception)&#xD;
&#xD;
          4. History of malignancies within the past two years or on current anticancer treatment&#xD;
&#xD;
          5. History of gastrointestinal pathology such as clinically relevant gastritis, gastric&#xD;
             ulcers, inflammatory bowel disease, chronic constipation&#xD;
&#xD;
          6. History of diarrhoea within the past 14 days of screening&#xD;
&#xD;
          7. History of gastrointestinal surgery with exception of appendectomy&#xD;
&#xD;
          8. History of any chronic liver disease&#xD;
&#xD;
          9. History of autoimmune disease requiring treatment within the past two months of&#xD;
             screening&#xD;
&#xD;
         10. Known symptomatic food allergies&#xD;
&#xD;
         11. Active infection (including HIV and hepatitis B or C), or abnormalities in laboratory&#xD;
             testing, vital signs, or physical examination&#xD;
&#xD;
         12. Hypersensitivity to aluminium and/or silicon&#xD;
&#xD;
         13. Chronic renal disease requiring dialysis&#xD;
&#xD;
         14. Alcohol, cigarette or drug abuse&#xD;
&#xD;
         15. Presence of any condition that impacts compliance with the study procedures&#xD;
&#xD;
         16. Use of any investigational or non-registered product (drug or device) within 30 days&#xD;
             preceding the first study product administration, or planned use during the study&#xD;
             period&#xD;
&#xD;
         17. Employee at the study site, spouse/partner or relative of any study staff (e.g.&#xD;
             investigator, sub-investigators, or study nurse) or relationship to the sponsor&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael Wolzt, Prof.Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Clinical Pharmacology, Medical University of Vienna</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Clinical Pharmacology, Medical University of Vienna</name>
      <address>
        <city>Vienna</city>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>July 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2020</study_first_posted>
  <last_update_submitted>November 12, 2020</last_update_submitted>
  <last_update_submitted_qc>November 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT04494178
org study id: G-Fum_01
nct id: NCT04494178
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This prospective, placebo-controlled, randomized, monocentric, double-blind, crossover study
      in healthy volunteers aims to assess the effect of a single dose of 2 g G-PUR® on
      bioavailability of dietary fumonisin and to evaluate safety and tolerability.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: The bioavailability of fumonisin is estimated based on the concentration of urinary biomarkers FB1 and FB2
time frame: 24 hours
measure: Incidence of (serious) adverse device effects
time frame: 19 days
measure: Urinary biomarkers FB1 and FB2 (separately and sum of FB1 and FB2)
time frame: 24 hours
arm group label: 2.0g G-PUR® oral - Placebo
arm group type: Experimental
arm group label: Placebo - 2.0g G-PUR® oral
arm group type: Experimental
intervention type: Device
intervention name: 2.0g G-PUR®
description: Oral administration (Intervention period I)
arm group label: 2.0g G-PUR® oral - Placebo
intervention type: Device
intervention name: 2.0g G-PUR®
description: Oral administration (Intervention period II)
arm group label: Placebo - 2.0g G-PUR® oral
intervention type: Other
intervention name: Placebo
description: Intervention period I
arm group label: Placebo - 2.0g G-PUR® oral
intervention type: Other
intervention name: Placebo
description: Intervention period II
arm group label: 2.0g G-PUR® oral - Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Michael Wolzt, Prof.Dr.
role: Principal Investigator
affiliation: Department of Clinical Pharmacology, Medical University of Vienna
facility: 
country: Austria
responsible party type: Sponsor