G-PUR® for Reduced Lead Bioavailability

Glock Health, Science and Research

Status

Completed

Conditions

Lead Exposure

Treatments

Device: G-PUR® 1x 2.0 g oral suspension

Device: Placebo oral suspension

Device: G-PUR® 2x 2.0 g oral suspension

Study type

Interventional

Funder types

Industry

Identifiers

NCT04138693

G-Lead_01

Details and patient eligibility

About

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).

Enrollment

42 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.
Written informed consent

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%
Known symptomatic food allergies
Any clinically relevant laboratory abnormalities in screening test
Alcohol, cigarette or drug abuse
Mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study
Presence of any condition that impacts compliance with the study procedures
Use of any regular medication (prescription or over the counter) for prevention or treatment of any medical condition
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
IMD should not be applied to patients that suffer from aluminium and/or silicon hypersensitivity or in case of renal failure that requires dialysis.