Metabolism of the Insecticide Permethrin

Pharmacokinetics Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00572884
• Other study ID #: 200311123-8
• Secondary ID: DAMD17-01-1-0769
• Status: Completed
• Phase: N/A
• First received: December 11, 2007
• Last updated: December 11, 2007
• Start date: February 2006
• Est. completion date: November 2007

Study information

• Verified date: December 2007
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: November 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Metabolism
• Pharmacokinetics

Intervention

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

Locations

Country	Name	City	State
United States	CTSC Research Center	Mather	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Davis	U.S. Army Medical Research and Materiel Command

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentration of individual metabolites in urine		192 hours	No
Secondary	total carbon-14 in serum		192 hours	No
Secondary	Total carbon-14 in saliva		192 hours	No
Secondary	Total carbon-14 in urine samples		192 hours	No