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Serum Pharmacokinetic Disposition and Urinary Excretion of Albendazole

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ClinicalTrials.gov Identifier: NCT03192449
Recruitment Status : Completed
First Posted : June 20, 2017
Last Update Posted : June 22, 2017
Sponsor:
Collaborator:
CIVETAN CONICET, Facultad de Ciencias Veterinarias, UNCPBA. Tandil
Information provided by (Responsible Party):
Alejandro Krolewiecki, 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.


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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Pharmacokinetics
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 : November 21, 2016
Actual Primary Completion Date : December 15, 2016
Actual Study Completion Date : January 20, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Albendazole

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




Primary Outcome Measures :
  1. Albendazole in urine [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03192449


Sponsors and Collaborators
Universidad Nacional de Salta
CIVETAN CONICET, Facultad de Ciencias Veterinarias, UNCPBA. Tandil
Investigators
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Study Director: Alejandro J Krolewiecki, MD/PhD Universidad Nacional de Salta

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Alejandro Krolewiecki, Principal Investigator, Universidad Nacional de Salta
ClinicalTrials.gov Identifier: NCT03192449     History of Changes
Other Study ID Numbers: CIVETAN-IIET-ALB01
First Posted: June 20, 2017    Key Record Dates
Last Update Posted: June 22, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Publication in peer review journal

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Helminthiasis
Parasitic Diseases
Albendazole
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents
Anticestodal Agents
Antiplatyhelmintic Agents
Antiprotozoal Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents