G-PUR® for Reduced Lead Bioavailability

NCT ID: NCT04138693

Last Updated: 2020-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-24
• Study Completion Date: 2020-02-12

Brief Summary

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).

Conditions

Lead Exposure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Cohort 1: 2 x 2.0 g G-PUR® oral suspension

Group Type: EXPERIMENTAL

G-PUR® 2x 2.0 g oral suspension

Intervention Type: DEVICE

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

Cohort 2: 1 x 2.0 g G-PUR® oral suspension

Group Type: EXPERIMENTAL

G-PUR® 1x 2.0 g oral suspension

Intervention Type: DEVICE

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

Cohort 3: Placebo oral suspension

Group Type: PLACEBO_COMPARATOR

Placebo oral suspension

Intervention Type: DEVICE

Cohort 3: 100 ml of water in an opaque drinking bottle will be orally administered immediately before and after 204Pb intake

Interventions

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

Intervention Type: 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

Intervention Type: 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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Glock Health, Science and Research GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christa Firbas, Dr.

Role: PRINCIPAL_INVESTIGATOR

Medical University Vienna, Department of Clinical Pharmacology

Locations

Department of Clinical Pharmacology, Medical University of Vienna

Vienna, , Austria

Countries

Austria

References

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.

Reference Type: DERIVED

PMID: 34285282 (View on PubMed)

Other Identifiers

G-Lead_01

Identifier Type: -

Identifier Source: org_study_id