Neglected Tropical Diseases Clinical Trial
Official title:
Serum Pharmacokinetic Disposition and Urinary Excretion of Albendazole and Its Metabolites in Non-infected Human Volunteers.
Mass drug administration (MDA) of albendazole (ABZ) to school-age and pre-school-age
children is the currently recommended strategy for controlling soil-transmitted
helminthiasis (STH) in endemic areas. Recent mathematical modelling suggests that
community-wide MDA will be required in order to interrupt transmission of STH. DEWORM3 aims
to determine the feasibility of eliminating STH through expanded and intensified MDA
strategies. In order to ensure rigorous trial results, it is crucial that the definition of
such MDA coverage is informed by unbiased, empirical data. The Centro de Investigación
Veterinaria de Tandil (CIVETAN) and Instituto de Investigaciones en Enfermedades Tropicales
Universidad Nacional de Salta collaborate on scientific research related to pharmacokinetic
studies of ABZ.
This proposal describes the request for funding from DEWORM3 to conduct a study of the serum
pharmacokinetic characteristics and urinary excretion of ABZ and its metabolites in
non-infected human volunteers to better understand the use of urinary analysis of ABZ as a
measure of MDA adherence in the context of DEWORM3.
Objective 1.To characterize the plasma disposition kinetics of ABZ and its main metabolites
(ABZ sulphoxide and ABZ sulphone) in non-infected human volunteers.
Objective 2. To characterize the pattern of albendazole (ABZ) and its main metabolites (ABZ
sulphoxide and ABZ sulphone) urinary excretion in non-infected human volunteers.
Objective 3. To determine the optimal and the longest period time after treatment where
either ABZ and/or its metabolites can be measured in urine as an indirect assessment of an
individual's adherence to treatment.
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