Serum Pharmacokinetic Disposition and Urinary Excretion of Albendazole

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.

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Key information

Conditions

Soil Transmitted Helminthiasis Disease Attributes Neglected Diseases Neglected Tropical Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Weight between 45 and 75 Kg.
Physical exam without significant abnormal findings.

Exclusion criteria

Intake of ABZ or other benzimidazole drugs within the last 30 days.
Malabsorption or other GI syndromes that could compromise the tolerability or absorption of ABZ.
History of hypersensitivity or intolerance to ABZ or its inactive ingredients.
Acute clinical conditions.
Pregnancy or breast feeding.

Treatment and study plan

Albendazole.

Drug

Single dose 400mg orally

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Universidad Nacional de Salta

Other

Collaborators

CIVETAN CONICET, Facultad de Ciencias Veterinarias, UNCPBA. Tandil

Registry information

Official study title

Serum Pharmacokinetic Disposition and Urinary Excretion of Albendazole and Its Metabolites in Non-infected Human Volunteers.

Important dates

Study start: 2016
Primary completion: 2016
Study completion: 2017
First posted: Jun 20, 2017
Registry last updated: Jun 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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