Metabolism of the Insecticide Permethrin

This study has been completed.
Sponsor:
Collaborator:
U.S. Army Medical Research and Materiel Command
Information provided by:
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00572884
First received: December 11, 2007
Last updated: NA
Last verified: December 2007
History: No changes posted
  Purpose

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 Intervention
Pharmacokinetics
Metabolism
Other: permethrin insecticide

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: CCRC:Identification and Development of Biological Markers of Human Exposure to the Insecticide Permethrin

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • Concentration of individual metabolites in urine [ Time Frame: 192 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • total carbon-14 in serum [ Time Frame: 192 hours ] [ Designated as safety issue: No ]
  • Total carbon-14 in saliva [ Time Frame: 192 hours ] [ Designated as safety issue: No ]
  • Total carbon-14 in urine samples [ Time Frame: 192 hours ] [ Designated as safety issue: No ]

Enrollment: 6
Study Start Date: February 2006
Study Completion Date: November 2007
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
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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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, P42 ES004699
Study First Received: December 11, 2007
Last Updated: December 11, 2007
Health Authority: United States: Institutional Review Board

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
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 29, 2014