Soil Transmitted HelminthiasisPhase 1NCT03192449
Serum Pharmacokinetic Disposition and Urinary Excretion of Albendazole
A Phase 1 study testing Albendazole. in people with Soil Transmitted Helminthiasis and Neglected Tropical Diseases, run by Universidad Nacional de Salta.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Soil Transmitted Helminthiasis, Neglected Tropical Diseases
- What is being tested?
- Albendazole.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- 21 Nov 2016to 20 Jan 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Weight between 45 and 75 Kg.
- Physical exam without significant abnormal findings.
Who cannot join
- 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.
About this study
Official title: Serum Pharmacokinetic Disposition and Urinary Excretion of Albendazole and Its Metabolites in Non-infected Human Volunteers.
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.
Read the 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.
- Being tested
- Albendazole.
- Medical subject headings
- Neglected Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Albendazole.Drug
Single dose 400mg orally
| Study group | Role | What they receive |
|---|---|---|
| Albendazole 400mg p.o. single dose | Experimental | Volunteers receive 1 tablet albendazole 400mg (GSK) fasting. Receives: Drug: Albendazole. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2017
- Study start21 Nov 2016
- Primary completion15 Dec 2016
- Study completion20 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Soil Transmitted HelminthiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pharmacokinetics
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Nacional de Salta
- Sponsor type
- University, hospital or other
- Collaborators
- CIVETAN CONICET, Facultad de Ciencias Veterinarias, UNCPBA. Tandil
- Responsible party
- Principal investigator, Alejandro Krolewiecki, Universidad Nacional de Salta
- Investigators
- Alejandro J Krolewiecki, MD/PhD, Study director, Universidad Nacional de Salta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03192449
- Sponsor's protocol ID
- CIVETAN-IIET-ALB01
- Status last verified
- Jun 2017
- First submitted
- 16 Jun 2017
- Last updated
- 22 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Publication in peer review journal
Publications
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.
PubMed 29346367
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Pharmacokinetic Disposition and Urinary Excretion of Albendazole and Its Metabolites in Non-infected Human Volunteers.
- ClinicalTrials.gov ID
- NCT03192449
- Acronym / sponsor ID
- CIVETAN-IIET-ALB01
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Universidad Nacional de SaltaUniversity, hospital or other
- Collaborators
- CIVETAN CONICET, Facultad de Ciencias Veterinarias, UNCPBA. Tandil
- Study start
- 21 Nov 2016 (actual)
- Primary completion
- 15 Dec 2016 (actual)
- Study completion
- 20 Jan 2017 (actual)
- First posted
- 20 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pharmacokinetics
| Arm | Type | Receives |
|---|---|---|
| Albendazole 400mg p.o. single dose | Experimental | Drug: Albendazole.Volunteers receive 1 tablet albendazole 400mg (GSK) fasting. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Weight between 45 and 75 Kg.
- Physical exam without significant abnormal findings.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Albendazole.Single dose 400mg orally | Drug | Albendazole 400mg p.o. single dose |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2017.
- Derived from this study: PubMed 29346367Ceballos 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.
- Individual participant dataSharing planned: Yes. Publication in peer review journal
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alejandro J Krolewiecki, MD/PhD study director
Universidad Nacional de Salta
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Albendazole. in people with Soil Transmitted Helminthiasis and Neglected Tropical Diseases, run by Universidad Nacional de Salta.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Albendazole in urine (time frame: Up to 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03192449, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2017.