Serum Pharmacokinetic Disposition and Urinary Excretion of Albendazole

NCT03192449 | Completed Phase 1

• 1 other identifier: CIVETAN-IIET-ALB01
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Soil Transmitted Helminthiasis; Neglected Tropical Diseases

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Albendazole 400mg p.o. single dose

EXPERIMENTAL

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

Drug: Albendazole.

Interventions

Albendazole. DRUG

Single dose 400mg orally

Albendazole 400mg p.o. single dose

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Nacional de Salta: lead
• CIVETAN CONICET, Facultad de Ciencias Veterinarias, UNCPBA. Tandil: collaborator

Related Publications (1)

• Ceballos L, Krolewiecki A, Juarez M, Moreno L, Schaer F, Alvarez LI, Cimino R, Walson J, Lanusse CE. Assessment of serum pharmacokinetics and urinary excretion of albendazole and its metabolites in human volunteers. PLoS Negl Trop Dis. 2018 Jan 18;12(1):e0005945. doi: 10.1371/journal.pntd.0005945. eCollection 2018 Jan.

  PMID: 29346367 DERIVED

MeSH Terms

Conditions

Neglected Diseases

Interventions

Albendazole

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Alejandro J Krolewiecki, MD/PhD

  Universidad Nacional de Salta

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Pharmacokinetics

Study Record Dates

• First Submitted: June 16, 2017
• First Posted: June 20, 2017
• Study Start: November 21, 2016
• Primary Completion: December 15, 2016
• Study Completion: January 20, 2017
• Last Updated: June 22, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will share