Ignite Creation Date:
2024-05-06 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 12:51 PM
Study NCT ID:
NCT03631667
Status:
COMPLETED
Last Update Posted:
2024-02-15
First Post:
2018-08-08
Brief Title:
Ultralow Dose PAH Binary Mixture Study
Sponsor:
Oregon State University
Organization:
Oregon State University
Study Overview
Official Title:
Ultralow Dose PAH Binary Mixture Study
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Evaluation of the pharmacokinetics for 14C-benzoapyrene 14C-BaP and metabolites in plasma and urine over 48 hours following a 50 ng dose 54 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 54 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 year70 Kg individual cancer endpoint exposure to BaP of 42-350 ng This protocol represents de minimus risk
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01ES028600 | NIH | None | httpsreporternihgovquickSearchR01ES028600 |