Serum Pharmacokinetic Disposition and Urinary Excretion of Albendazole
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|ClinicalTrials.gov Identifier: NCT03192449|
Recruitment Status : Completed
First Posted : June 20, 2017
Last Update Posted : June 22, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Soil Transmitted Helminthiasis Neglected Tropical Diseases||Drug: Albendazole.||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Pharmacokinetics|
|Masking:||None (Open Label)|
|Official Title:||Serum Pharmacokinetic Disposition and Urinary Excretion of Albendazole and Its Metabolites in Non-infected Human Volunteers.|
|Actual Study Start Date :||November 21, 2016|
|Actual Primary Completion Date :||December 15, 2016|
|Actual Study Completion Date :||January 20, 2017|
Experimental: Albendazole 400mg p.o. single dose
Volunteers receive 1 tablet albendazole 400mg (GSK) fasting.
Single dose 400mg orally
- Albendazole in urine [ Time Frame: Up to 72 hours ]Urinary excretion of albendazole (ABZ) and its main metabolites (ABZ sulphoxide and ABZ sulphone) in non-infected human volunteers. PK parameters (Cmax, AUC, Tmax) from levels measured through HPLC
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03192449
|Study Director:||Alejandro J Krolewiecki, MD/PhD||Universidad Nacional de Salta|