Serum Pharmacokinetic Disposition and Urinary Excretion of Albendazole

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-21

Study Completion Date

2017-01-20

Brief Summary

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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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Detailed Description

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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.

Conditions

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Soil Transmitted Helminthiasis Neglected Tropical Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Pharmacokinetics

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Albendazole 400mg p.o. single dose

Volunteers receive 1 tablet albendazole 400mg (GSK) fasting.

Group Type EXPERIMENTAL

Albendazole.

Intervention Type DRUG

Single dose 400mg orally

Interventions

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Albendazole.

Single dose 400mg orally

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes