Early Phase 1
N=8
Benzo[a]Pyrene Ultralow Dose-Response Study
Environmental Exposure
Bottom Line
View on ClinicalTrials.gov: NCT03318978 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
May 2025
Primary outcome: Primary: Peak Plasma Concentration Cmax — 2.51; 5.68; 13.8; 8.99 fg [14C]-BaP/mL plasma
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- [14C]-benzo[a]pyrene (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Oregon State University
- Primary completion
- Jan 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Peak Plasma Concentration Cmax |
2.51; 5.68; 13.8; 8.99 | — |
| SECONDARY Time at Highest Plasma Concentration Tmax |
0.5; 0.5; 0.5; 0.5 | — |
| SECONDARY Area Under Plasma Concentration Versus Time Curve AUC |
12.2; 19.6; 88.5; 68.6 | — |
| SECONDARY Rate of Elimination (k1e) |
12.2; 19.6; 88.5; 68.6 | — |
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).
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
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.)
Data sourced from ClinicalTrials.gov (NCT03318978). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.