G-PUR® for Reduced Lead Bioavailability

Lead Exposure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04138693
• Other study ID #: G-Lead_01
• Status: Completed
• Phase: N/A
• Start date: September 24, 2019
• Est. completion date: February 12, 2020

Study information

• Verified date: June 2020
• Source: Glock Health, Science and Research GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: February 12, 2020
• Est. primary completion date: February 12, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lead Exposure

Intervention

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

Locations

Country	Name	City	State
Austria	Department of Clinical Pharmacology, Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Glock Health, Science and Research GmbH

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	204PbB Cmax normalized for total PbB	Cmax of 204PbB normalized for total natural PbB levels after intake of 204Pb-enriched water	216 hours
Secondary	Incidence of (S)ADE	Incidence of (serious) adverse device effects	216 hours
Secondary	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
Secondary	Plasma PK parameters - tmax of 204PbB	Time to reach the peak concentration: The sampling time at which Cmax was observed	216 hours
Secondary	204Pb concentrations in 24-hour urine	Measurement of 204Pb isotope tracer concentrations in 24-hour urine after intake of 204Pb enriched water	24 hours
Secondary	204Pb in single hairs	Lead isotope tracer (204Pb) distribution and ratio in single hairs	9 days