Expired Study
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Mather, California 95655


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.


Study summary:

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.


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


Study is Available At:


Original ID:

200311123-8


NCT ID:

NCT00572884


Secondary ID:

DAMD17-01-1-0769


Study Acronym:


Brief Title:

Metabolism of the Insecticide Permethrin


Official Title:

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


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

50 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of California, Davis


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Pharmacokinetics Study,


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

6


Enrollment Type:

Actual


Overall Contact Information

Official Name:Bruce D Hammock, PhD
Principal Investigator
University of California, Davis

Study Dates

Start Date:February 2006
Completion Date:November 2007
Completion Type:Actual
Verification Date:December 2007
Last Changed Date:December 11, 2007
First Received Date:December 11, 2007

Study Outcomes

Outcome Type:Primary Outcome
Measure:Concentration of individual metabolites in urine
Time Frame:192 hours
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:total carbon-14 in serum
Time Frame:192 hours
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Total carbon-14 in saliva
Time Frame:192 hours
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Total carbon-14 in urine samples
Time Frame:192 hours
Safety Issues:False

Study Interventions

Intervention Type:Other
Name:permethrin insecticide
Description:25 mg neat carbon-14 labelled permethrin applied dermally in isopropyl alcohol, once for 8 hours containing 1 microcurie of carbon-14

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of California, Davis
Agency Class:U.S. Fed
Agency Type:Collaborator
Agency Name:U.S. Army Medical Research and Materiel Command

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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