- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00572884
Metabolism of the Insecticide Permethrin
December 11, 2007 updated by: University of California, Davis
CCRC:Identification and Development of Biological Markers of Human Exposure to the Insecticide Permethrin
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
6
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Mather, California, United States, 95655
- CTSC Research Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Concentration of individual metabolites in urine
Time Frame: 192 hours
|
192 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
total carbon-14 in serum
Time Frame: 192 hours
|
192 hours
|
|
Total carbon-14 in saliva
Time Frame: 192 hours
|
192 hours
|
|
Total carbon-14 in urine samples
Time Frame: 192 hours
|
192 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Bruce D Hammock, PhD, University of California, Davis
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2006
Study Completion (Actual)
November 1, 2007
Study Registration Dates
First Submitted
December 11, 2007
First Submitted That Met QC Criteria
December 11, 2007
First Posted (Estimate)
December 13, 2007
Study Record Updates
Last Update Posted (Estimate)
December 13, 2007
Last Update Submitted That Met QC Criteria
December 11, 2007
Last Verified
December 1, 2007
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 200311123-8
- DAMD17-01-1-0769
- P42ES004699 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.