G-PUR® for Reduced Dietary Fumonisin Bioavailability

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Placebo-controlled, Double-blind, Cross-over Study to Evaluate the Effect of G-PUR® on Dietary Fumonisin Bioavailability

Conditions
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Reduction of Dietary Fumonisin Bioavailability

Intervention / Treatment
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* Device: 2.0g G-PUR®
* Device: 2.0g G-PUR®
* Other: Placebo
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male and female subjects Age 18-55 years BMI 17-27 Subjects are in good clinical and mental health as established by medical history and physical examination Subject understands the scope of the study and agrees to strictly adhere to the study related diet plan Written informed consent Exclusion Criteria: Pregnancy or breastfeeding. Lack of willingness or capacity to co-operate appropriately Regular use of medications in the previous 2 months (except oral contraception) History of malignancies within the past two years or on current anticancer treatment History of gastrointestinal pathology such as clinically relevant gastritis, gastric ulcers, inflammatory bowel disease, chronic constipation History of diarrhoea within the past 14 days of screening History of gastrointestinal surgery with exception of appendectomy History of any chronic liver disease History of autoimmune disease requiring treatment within the past two months of screening Known symptomatic food allergies Active infection (including HIV and hepatitis B or C), or abnormalities in laboratory testing, vital signs, or physical examination Hypersensitivity to aluminium and/or silicon Chronic renal disease requiring dialysis Alcohol, cigarette or drug abuse Presence of any condition that impacts compliance with the study procedures Use of any investigational or non-registered product (drug or device) within 30 days preceding the first study product administration, or planned use during the study period Employee at the study site, spouse/partner or relative of any study staff (e.g. investigator, sub-investigators, or study nurse) or relationship to the sponsor

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2.0g G-PUR® oral - Placebo<br> | Device: 2.0g G-PUR®<br>* Oral administration (Intervention period I)<br>Other: Placebo<br>* Intervention period II<br>|
| Experimental: Placebo - 2.0g G-PUR® oral<br> | Device: 2.0g G-PUR®<br>* Oral administration (Intervention period II)<br>Other: Placebo<br>* Intervention period I<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The bioavailability of fumonisin is estimated based on the concentration of urinary biomarkers FB1 and FB2 |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of (serious) adverse device effects |  | 19 days | 
| Urinary biomarkers FB1 and FB2 (separately and sum of FB1 and FB2) |  | 24 hours |