Status:
COMPLETED
Pharmacokinetics of Benzo[a]Pyrene: Impact of Diet
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 a 50 ng dose (5.4 nCi) alone, following 7 days' consumption of...
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
- Age 21-65 (inclusive)
- If female, 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)
- Health history review and physical assessment showing general good health, as determined by study physician. Acceptable physical exam may have been conducted as part of protocol 8233 or 8554 if subject has not had significant changes in health status.
Exclusion
- 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.)
- Regular use of indole-3-carbinol or DIM dietary supplements
- Allergy or intolerance to Brussels sprouts or similar foods
Key Trial Info
Start Date :
January 24 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2024
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT03802721
Start Date
January 24 2019
End Date
February 1 2024
Last Update
June 22 2025
Active Locations (1)
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1
Oregon State University
Corvallis, Oregon, United States, 97331