Serum Pharmacokinetic Disposition and Urinary Excretion o... | NCT03192449

Studies
Serum Pharmacokinetic Disposition and Urinary Excretion of Albendazole

NCT03192449

Sponsor

Universidad Nacional de Salta

Status

Completed

Last Update Posted

Jun 22, 2017Actual

Enrollment

8Actual

Phase

Phase 1

Conditions

Soil Transmitted Helminthiasis
Neglected Tropical Diseases

Interventions

Albendazole.

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 21, 2016Actual

Primary Completion Date

Dec 15, 2016Actual

Completion Date

Jan 20, 2017Actual

First Submitted Date

Jun 16, 2017

First Submission Date that Met QC Criteria

Jun 16, 2017

First Posted Date

Jun 20, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 20, 2017

Last Update Posted Date

Jun 22, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Alejandro Krolewiecki, Principal Investigator, Universidad Nacional de SaltaPrincipal Investigator

Lead Sponsor

Universidad Nacional de SaltaOTHER

Collaborators

Name	Class
CIVETAN CONICET, Facultad de Ciencias Veterinarias, UNCPBA. Tandil	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

8Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Albendazole 400mg p.o. single dose	Experimental	Volunteers receive 1 tablet albendazole 400mg (GSK) fasting.	Drug: Albendazole.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Albendazole.	Drug	Single dose 400mg orally	Albendazole 400mg p.o. single dose

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alejandro J Krolewiecki, MD/PhD	Universidad Nacional de Salta	Study Director

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29346367	Derived	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.

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D002219	Carbamates
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals