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

Glock Health, Science and Research GmbH1 site in 1 country42 target enrollmentSeptember 24, 2019

ConditionsLead Exposure

Overview

Phase: N/A
Intervention: Not specified
Conditions: Lead Exposure
Sponsor: Glock Health, Science and Research GmbH
Enrollment: 42
Locations: 1
Primary Endpoint: 204PbB Cmax normalized for total PbB
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

September 24, 2019

End Date

February 12, 2020

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Glock Health, Science and Research GmbH

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy male and female subjects
•Age 18-45 years
•BMI 19-27 for males and BMI 17-25 for female
•Blood lead (PbB) concentration \< 40 μg/l
•Serum ferritin concentration within the sex-specific normal range, i.e. ≥ 15 - 150 ng/ml for women and 30 - 400 ng/ml for men
•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
•Subject is in good clinical and mental health as established by medical history and physical examination
•Stable eating habits, within one month before the start of the study
•Subject agrees to be compliant for study related diet schedule
•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.

Exclusion Criteria

•Pregnancy and breastfeeding
•Lack of willingness or capacity to co-operate appropriately
•Regular use of medications or iron supplements in the previous 2 months except intake of contraceptives
•Planning to shave head during study
•History of malignancies within the past two years or on current anticancer treatment
•History of gastrointestinal pathology such as gastritis, gastric ulcers, irritable bowel disease, 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 chronic autoimmune disease requiring treatment within the past two months of screening
•Known diabetes mellitus I or II or Hba1c \>6.5%