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Completed

NCT Number: NCT00572884

Metabolism of 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.

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Key information

Conditions

Pharmacokinetics Metabolism

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CTSC Research Center

Mather, California, 95655, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

permethrin insecticide

Other

25 mg neat carbon-14 labelled permethrin applied dermally in isopropyl alcohol, once for 8 hours containing 1 microcurie of carbon-14

Primary outcomes

  1. Concentration of individual metabolites in urine

    Time frame: 192 hours

Secondary outcomes

  1. total carbon-14 in serum

    Time frame: 192 hours

  2. Total carbon-14 in saliva

    Time frame: 192 hours

  3. Total carbon-14 in urine samples

    Time frame: 192 hours

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Collaborators

  • U.S. Army Medical Research and Development Command

Registry information

Official study title

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

Important dates

Study start
2006
Study completion
2007
First posted
Dec 13, 2007
Registry last updated
Dec 13, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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