NCT03159013

Brief Summary

Exposure to pyrethroid pesticides is a growing concern in the workplace especially since they are also present in the diet of the general population. It is important to monitor human exposure to these contaminants. Exposure to pyrethroids may occur by multiple routes of exposure (oral, inhalation and dermal), such that it is difficult to assess absorbed doses from external exposure assessments. Biological monitoring, which consists of measuring urinary metabolites, is now recognized by the scientific community as a preferred approach to assess exposure to this type of compound. These metabolites are biotransformation products produced in the human body from the exposure compounds. However, interpretation of these biological monitoring data requires a proper knowledge of the kinetic behavior and thus the fate of the substance of interest in the human body in order to link levels of biomarkers in individuals to actual absorbed doses. Human kinetic data are still poorly documented in the case of pyrethroids. The study in volunteers exposed to pyrethroids in controlled conditions will allow acquiring new urinary and blood profiles to refine and address uncertainties in the toxicokinetics of lambda-cyhalothrin following oral and dermal exposure. Those data will serve to build a toxicokinetic model to predict absorbed doses in workers from urinary metabolite measurements and therefore better assess health risks.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 22, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 19, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2017

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

May 15, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 18, 2017

Completed
Last Updated

May 19, 2017

Status Verified

May 1, 2017

Enrollment Period

2 months

First QC Date

May 15, 2017

Last Update Submit

May 17, 2017

Conditions

Exposure to Pollution

Keywords

PyrethroidsLambda-cyhalothrinBiomarkersToxicokinetics

Outcome Measures

Primary Outcomes (1)

  • Toxicokinetic parameters of lambda-cyhalothrin elimination after oral and dermal exposure.

    Elimination half-lives of biomarkers of exposure

    84-h post-treatment

Study Arms (2)

Pesticide toxicokinetics- oral

OTHER

Exposure type: ORAL Toxicokinetics

Other: Exposure

Pesticide toxicokinetics- dermal

OTHER

Exposure type: DERMAL Toxicokinetics

Other: Exposure

Interventions

ExposureOTHER

Oral exposure: 0,025 mg/kg bw dissolved in oil, on day 1, with blood withdrawn on days 2,3,4. Dermal exposure: 145 µl of commercial formulation (0,25 mg/kg bw) on 40 cm2 of forearm skin for 6 hours, on day 28, with blood withdrawn on days 29,30,31.

Pesticide toxicokinetics- dermalPesticide toxicokinetics- oral

Eligibility Criteria

Age21 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Good health
  • Caucasian origin (same group to have less genetic variability)

You may not qualify if:

  • Pyrethroid exposure at work or home (pet, garden)
  • Any kidney or liver illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Ratelle M, Cote J, Bouchard M. Time profiles and toxicokinetic parameters of key biomarkers of exposure to cypermethrin in orally exposed volunteers compared with previously available kinetic data following permethrin exposure. J Appl Toxicol. 2015 Dec;35(12):1586-93. doi: 10.1002/jat.3124. Epub 2015 Mar 13.

    PMID: 25772368BACKGROUND

  • Ratelle M, Cote J, Bouchard M. Toxicokinetics of permethrin biomarkers of exposure in orally exposed volunteers. Toxicol Lett. 2015 Jan 22;232(2):369-75. doi: 10.1016/j.toxlet.2014.12.003. Epub 2014 Dec 8.

    PMID: 25498136BACKGROUND

  • Cote J, Bonvalot Y, Carrier G, Lapointe C, Fuhr U, Tomalik-Scharte D, Wachall B, Bouchard M. A novel toxicokinetic modeling of cypermethrin and permethrin and their metabolites in humans for dose reconstruction from biomarker data. PLoS One. 2014 Feb 26;9(2):e88517. doi: 10.1371/journal.pone.0088517. eCollection 2014.

    PMID: 24586336BACKGROUND

Related Links

Study Officials

  • Michèle Bouchard, PhD

    Université de Montréal

    PRINCIPAL INVESTIGATOR

  • Jonathan Côté, MSc

    Université de Montréal

    PRINCIPAL INVESTIGATOR

  • Rania Khemiri, BSc

    Université de Montréal

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 15, 2017

First Posted

May 18, 2017

Study Start

September 22, 2016

Primary Completion

November 19, 2016

Study Completion

April 30, 2017

Last Updated

May 19, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share