G-PUR® for Reduced Lead Bioavailability

NCT04138693 | Completed

• 1 other identifier: G-Lead_01
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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

Keywords

Blood/Urine/Hair lead; Lead uptake & Lead bioavailability

Outcome Measures

Primary Outcomes (1)

• 204PbB Cmax normalized for total PbB

  Cmax of 204PbB normalized for total natural PbB levels after intake of 204Pb-enriched water

  216 hours

Secondary Outcomes (5)

• Incidence of (S)ADE

  216 hours

• Plasma PK parameters - AUC0-t of 204PbB

  216 hours

• Plasma PK parameters - tmax of 204PbB

  216 hours

• 204Pb concentrations in 24-hour urine

  24 hours

• 204Pb in single hairs

  9 days

Study Arms (3)

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

Cohort 3: Placebo oral suspension

PLACEBO COMPARATOR

Device: Placebo oral suspension

Interventions

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

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

Placebo oral suspension DEVICE

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

Cohort 3: Placebo oral suspension

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Glock Health, Science and Research GmbH: lead

Study Sites (1)

Department of Clinical Pharmacology, Medical University of Vienna

Vienna, Austria

Location

Related Publications (1)

• 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.

  PMID: 34285282 DERIVED

Study Officials

• Christa Firbas, Dr.

  Medical University Vienna, Department of Clinical Pharmacology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2019
• First Posted: October 24, 2019
• Study Start: September 24, 2019
• Primary Completion: February 12, 2020
• Study Completion: February 12, 2020
• Last Updated: June 4, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)