G-PUR® for Reduced Dietary Fumonisin Bioavailability | NCT04494178

Studies
G-PUR® for Reduced Dietary Fumonisin Bioavailability

NCT04494178

Sponsor

Glock Health, Science and Research GmbH

Status

Terminated

Last Update Posted

Nov 16, 2020Actual

Enrollment

7Actual

Phase

Not Applicable

Conditions

Reduction of Dietary Fumonisin Bioavailability

Interventions

2.0g G-PUR®
2.0g G-PUR®
Placebo
Placebo

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2020

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Several analytical laboratories failed to develop and validate a suitable assay of urine fumonisin (the primary endpoint) up to date. Because of missing alternatives for an analytical laboratory the objective of the study cannot be met.

Expanded Access Info

Start Date

Aug 18, 2020Actual

Primary Completion Date

Nov 4, 2020Actual

Completion Date

Nov 4, 2020Actual

First Submitted Date

Jul 28, 2020

First Submission Date that Met QC Criteria

Jul 28, 2020

First Posted Date

Jul 31, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 12, 2020

Last Update Posted Date

Nov 16, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

7Actual

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
2.0g G-PUR®	Device	Oral administration (Intervention period I)	2.0g G-PUR® oral - Placebo

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

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

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided