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p450 Mediated Lung Toxicity

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00023114
First Posted: August 24, 2001
Last Update Posted: September 4, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institute of Environmental Health Sciences (NIEHS)
  Purpose
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.

Condition
Pulmonary Disease

Study Type: Observational
Study Design: Allocation: Random Sample
Primary Purpose: Screening

Further study details as provided by National Institute of Environmental Health Sciences (NIEHS):

Estimated Enrollment: 10
Study Start Date: September 2000
Estimated Study Completion Date: September 2001
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
All available organ donors in the Sacramento area
  Contacts and Locations
No Contacts or Locations Provided
  More Information

ClinicalTrials.gov Identifier: NCT00023114     History of Changes
Other Study ID Numbers: 8408-CP-001
First Submitted: August 22, 2001
First Posted: August 24, 2001
Last Update Posted: September 4, 2006
Last Verified: September 2006

Keywords provided by National Institute of Environmental Health Sciences (NIEHS):
lung function
smoking
metabolism

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases