Lead ExposureNCT04138693
G-PUR® for Reduced Lead Bioavailability
A study testing G-PUR® 2x 2.0 g oral suspension and G-PUR® 1x 2.0 g oral suspension in people with Lead Exposure, run by Glock Health, Science and Research GmbH at 1 site in Austria.
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). Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Lead Exposure
- What is being tested?
- G-PUR® 2x 2.0 g oral suspension and G-PUR® 1x 2.0 g oral suspension
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteAustria
- Study dates
- 24 Sep 2019to 12 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Clinical Pharmacology, Medical University of Vienna
Vienna
About this study
Official title: A Randomized, Placebo-controlled, Double-blind Study to Evaluate the Effect of G-PUR® on Enteral Lead Isotope 204Pb-absorption
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
- Being tested
- G-PUR® 2x 2.0 g oral suspension, G-PUR® 1x 2.0 g oral suspension, Placebo oral suspension
- Keywords
- Blood/Urine/Hair lead, Lead uptake & Lead bioavailability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
G-PUR® 2x 2.0 g oral suspensionDevice
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 suspensionDevice
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 suspensionDevice
Cohort 3: 100 ml of water in an opaque drinking bottle will be orally administered immediately before and after 204Pb intake
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: 2 x 2.0 g G-PUR® oral suspension | Experimental | Not described Receives: Device: G-PUR® 2x 2.0 g oral suspension |
| Cohort 2: 1 x 2.0 g G-PUR® oral suspension | Experimental | Not described Receives: Device: G-PUR® 1x 2.0 g oral suspension |
| Cohort 3: Placebo oral suspension | Placebo comparator | Not described Receives: Device: Placebo oral suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
204PbB Cmax normalized for total PbB
Cmax of 204PbB normalized for total natural PbB levels after intake of 204Pb-enriched water
Measured: 216 hours
Secondary outcomes (5)
Incidence of (S)ADE
Incidence of (serious) adverse device effects
Measured: 216 hours
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
Measured: 216 hours
Plasma PK parameters - tmax of 204PbB
Time to reach the peak concentration: The sampling time at which Cmax was observed
Measured: 216 hours
204Pb concentrations in 24-hour urine
Measurement of 204Pb isotope tracer concentrations in 24-hour urine after intake of 204Pb enriched water
Measured: 24 hours
204Pb in single hairs
Lead isotope tracer (204Pb) distribution and ratio in single hairs
Measured: 9 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2019
- Study start24 Sep 2019
- Primary completion12 Feb 2020
- Study completion12 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lead ExposureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glock Health, Science and Research GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christa Firbas, Dr., Principal investigator, Medical University Vienna, Department of Clinical Pharmacology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04138693
- Sponsor's protocol ID
- G-Lead_01
- Status last verified
- Jun 2020
- First submitted
- 16 Oct 2019
- Last updated
- 4 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34285282
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-controlled, Double-blind Study to Evaluate the Effect of G-PUR® on Enteral Lead Isotope 204Pb-absorption
- ClinicalTrials.gov ID
- NCT04138693
- Acronym / sponsor ID
- G-Lead_01
- Conditions
- Lead Exposure
- Keywords
- Blood/Urine/Hair lead, Lead uptake & Lead bioavailability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Glock Health, Science and Research GmbHIndustry (pharma, biotech, devices)
- Study start
- 24 Sep 2019 (actual)
- Primary completion
- 12 Feb 2020 (actual)
- Study completion
- 12 Feb 2020 (actual)
- First posted
- 24 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| G-PUR® 2x 2.0 g oral suspensionCohort 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 | Device | Cohort 1: 2 x 2.0 g G-PUR® oral suspension |
| G-PUR® 1x 2.0 g oral suspensionCohort 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 | Device | Cohort 2: 1 x 2.0 g G-PUR® oral suspension |
| Placebo oral suspensionCohort 3: 100 ml of water in an opaque drinking bottle will be orally administered immediately before and after 204Pb intake | Device | Cohort 3: Placebo oral suspension |
Primary outcome
204PbB Cmax normalized for total PbB
Time frame: 216 hours
Cmax of 204PbB normalized for total natural PbB levels after intake of 204Pb-enriched water
5 secondary outcomes
Incidence of (S)ADE
Time frame: 216 hours
Plasma PK parameters - AUC0-t of 204PbB
Time frame: 216 hours
Plasma PK parameters - tmax of 204PbB
Time frame: 216 hours
204Pb concentrations in 24-hour urine
Time frame: 24 hours
204Pb in single hairs
Time frame: 9 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
- Derived from this study: PubMed 34285282Samekova 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christa Firbas, Dr. principal investigator
Medical University Vienna, Department of Clinical Pharmacology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing G-PUR® 2x 2.0 g oral suspension and G-PUR® 1x 2.0 g oral suspension in people with Lead Exposure, run by Glock Health, Science and Research GmbH at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
204PbB Cmax normalized for total PbB (time frame: 216 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04138693, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2020.