Status:
COMPLETED
G-PUR® for Reduced Lead Bioavailability
Lead Sponsor:
Glock Health, Science and Research GmbH
Conditions:
Lead Exposure
Eligibility:
All Genders
18-45 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 24 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 12 2020
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT04138693
Start Date
September 24 2019
End Date
February 12 2020
Last Update
June 4 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Clinical Pharmacology, Medical University of Vienna
Vienna, Austria