Pharmacokinetics and Excretion of Albendazole and Its Metabolites in Saliva

Pharmacokinetics and Excretion of Albendazole and Its Metabolites in Saliva in Healthy Volunteers

This project will develop and assess the feasibility and acceptability of a salive-based assay to monitor adherence to Mass Drug Administration (MDA) campaigns within Soil-transmitted helminthiasis (STH) control programs, evaluating the salive and serum pharmacokinetics of ALBENDAZOLE (ABZ) and its metabolites.The final goal is to obtain a field ready tool for the measurement of adherence to anthelmintic treatment at a community level that serves as a coverage/adherence indicator and a reference standard for other monitoring tools.

Study Overview

• Status: Not yet recruiting
• Conditions: Pharmacological Action
• Intervention / Treatment: Drug: Albendazole

• Study Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alejandro J Krolewiecki, MD; Phone Number: +5491131838673; Email: alekrol@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Body Mass Index: 18 to 25.

Physical exam without significant abnormal findings.

Exclusion Criteria:

Pregnancy

Lactation

Use of ABZ or other benzimidazole drugs in the previous 30 days

History of intolerance to ABZ

Malabsorption and/or other gastrointestinal conditions that might compromise ABZ absorption.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Albendazole; 400 mg po single dose	Drug: Albendazole; tablet administration after a meal contaning approximate 15 g of fat; Other Names: Albendazole tablet, Albendazole 400mg po

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Salive albendazole levels	Albendazole and its metabolites will be measured in salive samples through high performance liquid chromatography (HPLC).	72 hours

Collaborators and Investigators

• Sponsor: Universidad Nacional de Salta
• Collaborators: Fundación Mundo Sano

Study record dates

Study Major Dates

• Study Start (Anticipated): July 18, 2022
• Primary Completion (Anticipated): August 30, 2022
• Study Completion (Anticipated): December 16, 2022

Study Registration Dates

• First Submitted: July 6, 2022
• First Submitted That Met QC Criteria: July 6, 2022
• First Posted (Actual): July 12, 2022

Study Record Updates

• Last Update Posted (Actual): July 14, 2022
• Last Update Submitted That Met QC Criteria: July 11, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antiprotozoal Agents; Antiparasitic Agents; Anthelmintics; Antiplatyhelmintic Agents; Anticestodal Agents; Albendazole
• Other Study ID Numbers: ABZ0301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No