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Metabolism of the Insecticide Permethrin

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ClinicalTrials.gov Identifier: NCT00572884
Recruitment Status : Completed
First Posted : December 13, 2007
Last Update Posted : December 13, 2007
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Pharmacokinetics Metabolism Other: permethrin insecticide

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: CCRC:Identification and Development of Biological Markers of Human Exposure to the Insecticide Permethrin
Study Start Date : February 2006
Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Permethrin
U.S. FDA Resources

Arms and Interventions

Intervention Details:
    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

Outcome Measures

Primary Outcome Measures :
  1. Concentration of individual metabolites in urine [ Time Frame: 192 hours ]

Secondary Outcome Measures :
  1. total carbon-14 in serum [ Time Frame: 192 hours ]
  2. Total carbon-14 in saliva [ Time Frame: 192 hours ]
  3. Total carbon-14 in urine samples [ Time Frame: 192 hours ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00572884


Locations
United States, California
CTSC Research Center
Mather, California, United States, 95655
Sponsors and Collaborators
University of California, Davis
U.S. Army Medical Research and Materiel Command
Investigators
Principal Investigator: Bruce D Hammock, PhD University of California, Davis
More Information

Responsible Party: Bruce D. Hammock, University of California
ClinicalTrials.gov Identifier: NCT00572884     History of Changes
Other Study ID Numbers: 200311123-8
DAMD17-01-1-0769
P42ES004699 ( U.S. NIH Grant/Contract )
First Posted: December 13, 2007    Key Record Dates
Last Update Posted: December 13, 2007
Last Verified: December 2007

Keywords provided by University of California, Davis:
permethrin
pyrethroid
pharmacokinetics
metabolism
accelerator mass spectrometry
human exposure

Additional relevant MeSH terms:
Permethrin
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action