G-PUR® for Reduced Lead Bioavailability

A Randomized, Placebo-controlled, Double-blind Study to Evaluate the Effect of G-PUR® on Enteral Lead Isotope 204Pb-absorption

This is a prospective, randomized, placebo-controlled, double blind, parallel-arm study in a two-staged approach that will assess the effect of two different doses of G-PUR® on enteral lead absorption in healthy adults using a stable lead isotopic tracer (204Pb).

Study Overview

• Status: Completed
• Conditions: Lead Exposure
• Intervention / Treatment: Device: G-PUR® 2x 2.0 g oral suspension; Device: G-PUR® 1x 2.0 g oral suspension; Device: Placebo oral suspension

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria
    • Department of Clinical Pharmacology, Medical University of Vienna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Healthy male and female subjects
2. Age 18-45 years
3. BMI 19-27 for males and BMI 17-25 for female
4. Blood lead (PbB) concentration < 40 μg/l
5. Serum ferritin concentration within the sex-specific normal range, i.e. ≥ 15 - 150 ng/ml for women and 30 - 400 ng/ml for men
6. Presence of scalp hair with a minimum length of 5 mm and willingness to remove 5 single hairs with hair roots at end of study visit
7. Subject is in good clinical and mental health as established by medical history and physical examination
8. Stable eating habits, within one month before the start of the study
9. Subject agrees to be compliant for study related diet schedule
10. Women of childbearing potential agree to use adequate birth control methods during the study (for all females, negative pregnancy test at screening and at Visit 3 before dosing of IMD is required. Females of childbearing potential must use adequate contraception during the entire study period. Acceptable methods of contraception include: oral contraceptives, intrauterine device, female or male condoms with spermicide, diaphragm with spermicide, contraceptive medication patch, contraceptive medication implant, contraceptive medication injection, abstinence, or surgical sterilization more than 3 months before randomization.
11. Written informed consent

Exclusion Criteria:

1. Pregnancy and breastfeeding
2. Lack of willingness or capacity to co-operate appropriately
3. Regular use of medications or iron supplements in the previous 2 months except intake of contraceptives
4. Planning to shave head during study
5. History of malignancies within the past two years or on current anticancer treatment
6. History of gastrointestinal pathology such as gastritis, gastric ulcers, irritable bowel disease, inflammatory bowel disease, chronic constipation
7. History of diarrhoea within the past 14 days of screening
8. History of gastrointestinal surgery with exception of appendectomy
9. History of chronic autoimmune disease requiring treatment within the past two months of screening
10. Known diabetes mellitus I or II or Hba1c >6.5%
11. Known symptomatic food allergies
12. Any clinically relevant laboratory abnormalities in screening test
13. Alcohol, cigarette or drug abuse
14. Mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study
15. Presence of any condition that impacts compliance with the study procedures
16. Use of any regular medication (prescription or over the counter) for prevention or treatment of any medical condition
17. 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
18. 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
19. IMD should not be applied to patients that suffer from aluminium and/or silicon hypersensitivity or in case of renal failure that requires dialysis.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1: 2 x 2.0 g G-PUR® oral suspension	Device: G-PUR® 2x 2.0 g oral suspension; Cohort 1: 2 g G-PUR® powder mixed with 100 ml water in an opaque drinking bottle will be orally administered before and immediately after 204Pb intake
Experimental: Cohort 2: 1 x 2.0 g G-PUR® oral suspension	Device: G-PUR® 1x 2.0 g oral suspension; Cohort 2: 2 g G-PUR® powder mixed with 100 ml water in an opaque drinking bottle will be orally administered before 204Pb intake and 100 ml water (placebo) in an opaque drinking bottle immediately after 204Pb intake
Placebo Comparator: Cohort 3: Placebo oral suspension	Device: Placebo oral suspension; Cohort 3: 100 ml of water in an opaque drinking bottle will be orally administered immediately before and after 204Pb intake

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
204PbB Cmax normalized for total PbB	Cmax of 204PbB normalized for total natural PbB levels after intake of 204Pb-enriched water	216 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of (S)ADE	Incidence of (serious) adverse device effects	216 hours
Plasma PK parameters - AUC0-t of 204PbB	The observed area under the blood concentration versus time curve between time 0 and the time point of the last quantifiable concentration, calculated using the trapezoidal rule method	216 hours
Plasma PK parameters - tmax of 204PbB	Time to reach the peak concentration: The sampling time at which Cmax was observed	216 hours
204Pb concentrations in 24-hour urine	Measurement of 204Pb isotope tracer concentrations in 24-hour urine after intake of 204Pb enriched water	24 hours
204Pb in single hairs	Lead isotope tracer (204Pb) distribution and ratio in single hairs	9 days

Collaborators and Investigators

• Sponsor: Glock Health, Science and Research GmbH
• Investigators: Principal Investigator: Christa Firbas, Dr., Medical University Vienna, Department of Clinical Pharmacology

Publications and helpful links

General Publications

• Samekova K, Firbas C, Irrgeher J, Opper C, Prohaska T, Retzmann A, Tschegg C, Meisslitzer C, Tchaikovsky A, Gouya G, Freissmuth M, Wolzt M. Concomitant oral intake of purified clinoptilolite tuff (G-PUR) reduces enteral lead uptake in healthy humans. Sci Rep. 2021 Jul 20;11(1):14796. doi: 10.1038/s41598-021-94245-x.

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2019
• Primary Completion (Actual): February 12, 2020
• Study Completion (Actual): February 12, 2020

Study Registration Dates

• First Submitted: October 16, 2019
• First Submitted That Met QC Criteria: October 23, 2019
• First Posted (Actual): October 24, 2019

Study Record Updates

• Last Update Posted (Actual): June 4, 2020
• Last Update Submitted That Met QC Criteria: June 2, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Blood/Urine/Hair lead; Lead uptake & Lead bioavailability
• Other Study ID Numbers: G-Lead_01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No