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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: 2 x 2.0 g G-PUR® oral suspension | Experimental |
| |
| Cohort 2: 1 x 2.0 g G-PUR® oral suspension | Experimental |
| |
| Cohort 3: Placebo oral suspension | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 204PbB Cmax normalized for total PbB | Cmax of 204PbB normalized for total natural PbB levels after intake of 204Pb-enriched water | 216 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of (S)ADE | Incidence of (serious) adverse device effects | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christa Firbas, Dr. | Medical University Vienna, Department of Clinical Pharmacology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Clinical Pharmacology, Medical University of Vienna | Vienna | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34285282 | Derived | 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. |
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| 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 |
|
| 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 |
|
| 216 hours |
| Plasma PK parameters - tmax of 204PbB | Time to reach the peak concentration: The sampling time at which Cmax was observed | 216 hours |
| 204Pb concentrations in 24-hour urine | Measurement of 204Pb isotope tracer concentrations in 24-hour urine after intake of 204Pb enriched water | 24 hours |
| 204Pb in single hairs | Lead isotope tracer (204Pb) distribution and ratio in single hairs | 9 days |