- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00023114
p450 Mediated Lung Toxicity
September 1, 2006 updated by: National Institute of Environmental Health Sciences (NIEHS)
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment
10
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
1 second and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
All available organ donors in the Sacramento area
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?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
September 1, 2000
Study Completion
September 1, 2001
Study Registration Dates
First Submitted
August 22, 2001
First Submitted That Met QC Criteria
August 23, 2001
First Posted (Estimate)
August 24, 2001
Study Record Updates
Last Update Posted (Estimate)
September 4, 2006
Last Update Submitted That Met QC Criteria
September 1, 2006
Last Verified
September 1, 2006
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 8408-CP-001
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.
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