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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
42
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 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 3: 100 ml of water in an opaque drinking bottle will be orally administered immediately before and after 204Pb intake
Department of Clinical Pharmacology, Medical University of Vienna
Vienna, Austria
204PbB Cmax normalized for total PbB
Cmax of 204PbB normalized for total natural PbB levels after intake of 204Pb-enriched water
Time frame: 216 hours
Incidence of (S)ADE
Incidence of (serious) adverse device effects
Time frame: 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
Time frame: 216 hours
Plasma PK parameters - tmax of 204PbB
Time to reach the peak concentration: The sampling time at which Cmax was observed
Time frame: 216 hours
204Pb concentrations in 24-hour urine
Measurement of 204Pb isotope tracer concentrations in 24-hour urine after intake of 204Pb enriched water
Time frame: 24 hours
204Pb in single hairs
Lead isotope tracer (204Pb) distribution and ratio in single hairs
Time frame: 9 days
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