Status:
COMPLETED
Benzo[a]Pyrene Ultralow Dose-Response Study
Lead Sponsor:
Oregon State University
Collaborating Sponsors:
National Institute of Environmental Health Sciences (NIEHS)
Lawrence Livermore National Laboratory
Conditions:
Environmental Exposure
Eligibility:
All Genders
21-65 years
Phase:
EARLY_PHASE1
Brief Summary
Evaluation of the pharmacokinetics for \[14C\]-benzo\[a\]pyrene (\[14C\]-BaP) and metabolites in plasma and urine over 48 hours following 4 oral doses of 25, 50, 10 and 250 ng (2.7-27 nCi).
Detailed Description
The pharmacokinetics for \[14C\]-BaP and metabolites will be assessed by UHLPC-Accelerator Mass Spectrometry (AMS, Lawrence Livermore National Laboratory) in plasma and urine collected over 48 hours f...
Eligibility Criteria
Inclusion
- Inclusion criteria for women:
- Age 21-65 (inclusive)
- Must be post-menopausal or have had surgical sterilization to eliminate any possibility for fetal exposure
- Willing to defer blood donation for one month before, throughout, and one month after completion of study activities
- Willing to avoid consuming cruciferous vegetables, I3C or DIM supplements, smoked or cured meat or cheeses, or charcoal-grilled meats for 2 weeks prior to and during each study cycle (gas grilled foods acceptable)
- Inclusion criteria for men:
- Age 21-65 (inclusive)
- Willing to defer blood donation for one month before, throughout, and one month after completion of study activities
- Willing to avoid consuming cruciferous vegetables, I3C or DIM supplements, smoked or cured meat or cheeses, or charcoal-grilled meats for 2 weeks prior to and during each study cycle (gas grilled foods acceptable)
Exclusion
- Exclusion criteria for both men and women:
- Smoker (tobacco or other substances) or use of smokeless tobacco in past 3 months or living with smoker
- Regular use of medications that affect gut motility or nutrient absorption (e.g. cholestyramine, sucralfate, orlistat, pro- or anti-motility agents)
- History of gastrointestinal surgery (e.g. bariatric surgery, cholecystectomy) or gastrointestinal disorder (Crohn's disease, celiac disease, IBS, or colitis)
- Current or history of kidney or liver disease
- Prior high-dose 14C exposure from medical tests. (micro-dose 14C exposure not exclusionary)
- Occupational PAH exposure (e.g. roofers, asphalt pavers, fire-fighters, etc.)
Key Trial Info
Start Date :
April 17 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2024
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT03318978
Start Date
April 17 2018
End Date
February 1 2024
Last Update
May 22 2025
Active Locations (1)
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1
Clinical Research Facility, 407 Linus Pauling Science Center, Oregon State University
Corvallis, Oregon, United States, 97331