NCT03318978

Benzo[a]Pyrene Ultralow Dose-Response Study

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Oregon State University · Academic / Other
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Accepted

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 following oral doses of 25, 50, 100 or 250 ng (2.7-27 nCi). Metabolite profiles and kinetics of elimination over this dose range are predicted to be consistent with a BaP physiologically based pharmacokinetic (PBPK) model developed by Pacific Northwest National Laboratory (PNNL). A non-smoker, not exposed occupationally, receives 270-700 ng of BaP daily; about 95% dietary. The WHO has set an estimated safe daily lifetime (70 year/70 Kg individual, cancer endpoint) exposure to BaP of 42-350 ng. This protocol represents de minimus risk.

Conditions

• Environmental Exposure

Interventions

Type	Name	Description
DRUG	[14C]-benzo[a]pyrene	Oral micro-dose range (25, 50, 100 and 250 ng)

Timeline

• Start date: 2018-04-17
• Primary completion: 2024-01-01
• Completion: 2024-02-01
• First posted: 2017-10-24
• Last updated: 2025-05-22
• Results posted: 2025-05-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study