Serum Pharmacokinetic Disposition and Urinary Excretion of Albendazole

Neglected Tropical Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03192449
• Other study ID #: CIVETAN-IIET-ALB01
• Status: Completed
• Phase: Phase 1
• First received: June 16, 2017
• Last updated: June 20, 2017
• Start date: November 21, 2016
• Est. completion date: January 20, 2017

Study information

• Verified date: June 2017
• Source: Universidad Nacional de Salta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: January 20, 2017
• Est. primary completion date: December 15, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Helminthiasis
• Neglected Tropical Diseases
• Soil Transmitted Helminthiasis

Intervention

Drug:
• Albendazole.
Single dose 400mg orally

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Universidad Nacional de Salta	CIVETAN CONICET, Facultad de Ciencias Veterinarias, UNCPBA. Tandil

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Albendazole in urine	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	Up to 72 hours