G-PUR® for Reduced Dietary Fumonisin Bioavailability

NCT04494178 | Terminated

• 1 other identifier: G-Fum_01
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Reduction of Dietary Fumonisin Bioavailability

Outcome Measures

Primary Outcomes (1)

• The bioavailability of fumonisin is estimated based on the concentration of urinary biomarkers FB1 and FB2

  24 hours

Secondary Outcomes (2)

• Incidence of (serious) adverse device effects

  19 days

• Urinary biomarkers FB1 and FB2 (separately and sum of FB1 and FB2)

  24 hours

Study Arms (2)

2.0g G-PUR® oral - Placebo

EXPERIMENTAL

Device: 2.0g G-PUR®; Other: Placebo

Placebo - 2.0g G-PUR® oral

EXPERIMENTAL

Device: 2.0g G-PUR®; Other: Placebo

Interventions

2.0g G-PUR® DEVICE

Oral administration (Intervention period I)

2.0g G-PUR® oral - Placebo

Placebo OTHER

Intervention period I

Placebo - 2.0g G-PUR® oral

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Glock Health, Science and Research GmbH: lead

Study Sites (1)

Department of Clinical Pharmacology, Medical University of Vienna

Vienna, Austria

Location

Study Officials

• Michael Wolzt, Prof.Dr.

  Department of Clinical Pharmacology, Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2020
• First Posted: July 31, 2020
• Study Start: August 18, 2020
• Primary Completion: November 4, 2020
• Study Completion: November 4, 2020
• Last Updated: November 16, 2020

Record last verified: 2020-11

Locations

AU (1)