Metabolism of the Insecticide Permethrin

December 11, 2007 updated by: University of California, Davis

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

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.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Mather, California, United States, 95655
        • CTSC Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Concentration of individual metabolites in urine
Time Frame: 192 hours
192 hours

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Bruce D Hammock, PhD, University of California, Davis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

December 11, 2007

First Submitted That Met QC Criteria

December 11, 2007

First Posted (Estimate)

December 13, 2007

Study Record Updates

Last Update Posted (Estimate)

December 13, 2007

Last Update Submitted That Met QC Criteria

December 11, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Other Study ID Numbers

  • 200311123-8
  • DAMD17-01-1-0769
  • P42ES004699 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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