Metabolism of the Insecticide Permethrin - Tabular View

Tracking Information

First Received Date ^ICMJE

December 11, 2007

Last Updated Date

December 11, 2007

Start Date ^ICMJE

February 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Metabolism of the Insecticide Permethrin

Official Title ^ICMJE

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

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.

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 Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Basic Science, Open Label, Single Group Assignment, Pharmacokinetics Study

Condition ^ICMJE

Pharmacokinetics
Metabolism

Intervention ^ICMJE

Other: permethrin insecticide

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

November 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 50 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00572884

Responsible Party

Bruce D. Hammock, University of California

Study ID Numbers ^ICMJE

200311123-8, DAMD17-01-1-0769, P42 ES004699

Study Sponsor ^ICMJE

University of California, Davis

Collaborators ^ICMJE

U.S. Army Medical Research and Materiel Command

Investigators ^ICMJE

Principal Investigator:

Bruce D Hammock, PhD

University of California, Davis

Information Provided By

University of California, Davis

Verification Date

December 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP