Metabolism of the Insecticide Permethrin - Full Text View

Sponsor:	University of California, Davis
Collaborator:	U.S. Army Medical Research and Materiel Command
Information provided by:	University of California, Davis
ClinicalTrials.gov Identifier:	NCT00572884

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:	Basic Science, Open Label, Single Group Assignment, Pharmacokinetics Study
Official Title:	CCRC:Identification and Development of Biological Markers of Human Exposure to the Insecticide Permethrin

Resource links provided by NLM:

MedlinePlus related topics: Urine and Urination

Drug Information available for: Permethrin

U.S. FDA Resources

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:

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

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:	University of California ( Bruce D. Hammock )
Study ID Numbers:	200311123-8, DAMD17-01-1-0769, P42 ES004699
Study First Received:	December 11, 2007
Last Updated:	December 11, 2007
ClinicalTrials.gov Identifier:	NCT00572884 History of Changes
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:

Molecular Mechanisms of Pharmacological Action
Permethrin
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010