Serum Pharmacokinetic Disposition and Urinary Excretion of Albendazole

Phase 1

Completed

• Conditions: Soil Transmitted Helminthiasis; Neglected Tropical Diseases
• Interventions: Drug: Albendazole.

• Registration Number: NCT03192449
• Lead Sponsor: Universidad Nacional de Salta

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2016-11-21
• Primary Completion: 2016-12-15
• Study Completion: 2017-01-20
• Status Verified: 2017-06
• Study First Submitted: 2017-06-16
• Study First Submitted QC: 2017-06-16
• Study First Posted: 2017-06-20
• Last Update Submitted: 2017-06-20
• Last Update Posted: 2017-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Albendazole 400mg p.o. single dose	Albendazole.	Volunteers receive 1 tablet albendazole 400mg (GSK) fasting.

Primary Outcome Measures

Name	Time	Method
Albendazole in urine	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