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NCT00023114 Clinical Trial

p450 Mediated Lung Toxicity

Pulmonary Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00023114
Other study ID # 8408-CP-001
Secondary ID
Status Completed
Phase N/A
First received August 22, 2001
Last updated September 1, 2006
Start date September 2000
Est. completion date September 2001

Study information
Verified date September 2006
Source National Institute of Environmental Health Sciences (NIEHS)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

The purpose of this project is to do cross species comparisons of the metabolism and toxicity of a number of toxicants which require metabolism for toxicity. All of the toxicants in question are encountered by humans in the workplace, through lifestyle choices (cigarette smoking) and as a result of environmental contamination. The high incidence of pulmonary diseases in the human population means that it will be difficult if not impossible to determine whether humans are at risk from exposure to these chemicals without solid mechanistic data. Recent rodent bioassays suggest that these compounds have oncogenic potential further supporting the need to test the potential for injury in primates. As part of this testing, we intend to establish in vitro methods for assessing critical steps in the metabolism of these agents and their interaction with cellular macromolecules. Once this is done, similar studies can be conducted in Rhesus or in human lung tissue that is available because it cannot be used for transplant purposes.

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date September 2001
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility All available organ donors in the Sacramento area

Study Design

Allocation: Random Sample, Primary Purpose: Screening

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
National Institute of Environmental Health Sciences (NIEHS)
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