Benzo[a]Pyrene Ultralow Dose-Response Study
Completed · Early Phase 1
Conditions studied: Environmental Exposure
In brief
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).
Key facts
- Study ID
- NCT03318978
- Run by
- Oregon State University
- People needed
- 8
- Starts
- 2018-04-17
- Expected to finish
- 2024-02-01
- Last updated by the study team
- 2025-05-22
Who can join
Age: 21 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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.)
Where it is running
- Clinical Research Facility, 407 Linus Pauling Science Center, Oregon State University — Corvallis, Oregon, United States
Full record on ClinicalTrials.gov
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