Serum Pharmacokinetic Disposition and Urinary Excretion of Albendazole

Sponsor

Universidad Nacional de Salta (Other)

Overall Status

Completed

CT.gov ID

NCT03192449

Collaborator

CIVETAN CONICET, Facultad de Ciencias Veterinarias, UNCPBA. Tandil (Other)

Enrollment

Arm

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Soil Transmitted Helminthiasis Neglected Tropical Diseases	Drug: Albendazole.	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

8 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

PharmacokineticsPharmacokinetics

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Nov 21, 2016

Actual Primary Completion Date :

Dec 15, 2016

Actual Study Completion Date :

Jan 20, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Albendazole 400mg p.o. single dose Volunteers receive 1 tablet albendazole 400mg (GSK) fasting.	Drug: Albendazole. Single dose 400mg orally

Arm

Intervention/Treatment

Experimental: Albendazole 400mg p.o. single dose

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

Drug: Albendazole.

Single dose 400mg orally

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

Study Director: Alejandro J Krolewiecki, MD/PhD, Universidad Nacional de Salta

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Alejandro Krolewiecki, Principal Investigator, Universidad Nacional de Salta

ClinicalTrials.gov Identifier:

NCT03192449

Other Study ID Numbers:

CIVETAN-IIET-ALB01

First Posted:

Jun 20, 2017

Last Update Posted:

Jun 22, 2017

Last Verified:

Jun 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Helminthiasis

Albendazole

Study Results

No Results Posted as of Jun 22, 2017