Metabolism of the Insecticide Permethrin

Study Overview
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Brief Summary
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Military personnel are exposed to the insecticide permethrin when using the DOD Insect Repellent System. A urinary metabolite of permethrin that is in high abundance and is relatively stable may be an ideal biomarker of exposure to this pesticide. Monitoring such a biomarker can prevent over-exposure. The objectives are to identify the most abundant human urinary metabolite following dermal exposure; to utilize this information to develop rapid laboratory-based and field portable methods to monitor the degree of an individual's exposure to permethrin.

Detailed Description
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Permethrin is applied to the forearm of the subject and remains for 8 hours. The exposed area is then washed with soap and water several times. 24 hour urine samples are collected at daily intervals for 192 hours. Blood and saliva samples are taken at pre-dose, 1, 3, 6, 9 12, 24, 48, 72, 96, 120, 144, 168 and 192 hours. Subjects must return to the clinic daily to drop off urine collections and have blood and saliva samples taken.

Official Title
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CCRC:Identification and Development of Biological Markers of Human Exposure to the Insecticide Permethrin

Conditions
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Pharmacokinetics, Metabolism

Intervention / Treatment
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* Other: permethrin insecticide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: self-report healthy adult men and premenopausal women Exclusion Criteria: unusual alcohol, drug, cigarette use for last 3 years unusual exercise program for last 3 years under the care of a physician for a disease participated in any radioactive drug study pregnant lactating people who rely more on their arm due to illness or injury people with neurological or musculoskeletal diseases use of permethrin in the last 6 months people who apply pesticides as their primary occupation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: permethrin insecticide|25 mg neat carbon-14 labelled permethrin applied dermally in isopropyl alcohol, once for 8 hours containing 1 microcurie of carbon-14|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of individual metabolites in urine |  | 192 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total carbon-14 in serum |  | 192 hours | 
| Total carbon-14 in saliva |  | 192 hours | 
| Total carbon-14 in urine samples |  | 192 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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permethrin, pyrethroid, pharmacokinetics, metabolism, accelerator mass spectrometry, human exposure