NCT03631667

Ultralow Dose PAH Binary Mixture 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 a 50 ng dose (5.4 nCi) alone or with 1250 ng phenanthrene.

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 50 ng dose (5.4 nCi) alone or with 1250 ng phenanthrene. Metabolite profiles and kinetics of elimination 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 (50 ng) (5.4 nCi)
DRUG	[14C]-benzo[a]pyrene plus phenanthrene	Oral micro-dose of 50 ng (5.4 nCi) \[14C\]-benzo\[a\]pyrene plus 1250 ng phenanthrene

Timeline

• Start date: 2018-10-01
• Primary completion: 2024-01-01
• Completion: 2024-02-01
• First posted: 2018-08-15
• Last updated: 2025-05-22
• Results posted: 2025-05-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study