NCT03159013

Toxicokinetic Study of Lambda-cyhalothrin Biomarkers of Exposure

Completed NA Last updated 19 May 2017

What this trial tests

NA trial testing Exposure in Exposure to Pollution in 7 participants. Completed in 30 April 2017.

Timeline

22 September 2016

Primary endpoint
19 November 2016

30 April 2017

Quick facts

Lead sponsor	Université de Montréal
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	crossover
Masking	single
Primary purpose	basic science
Enrollment	7
Start date	22 September 2016
Primary completion	19 November 2016
Estimated completion	30 April 2017

Drugs / interventions tested

• Exposure

Conditions studied

• Exposure to Pollution — all drugs for Exposure to Pollution →

Sponsor

Université de Montréal — full company profile →

Who can join

Adults 21 to 64, any sex, with Exposure to Pollution. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.