Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03631667
Other study ID # LPI-8554
Secondary ID R01ES028600
Status Completed
Phase Early Phase 1
First received
Last updated
Start date October 1, 2018
Est. completion date February 1, 2024

Study information

Verified date February 2024
Source Oregon State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 5
Est. completion date February 1, 2024
Est. primary completion date January 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 65 Years
Eligibility Inclusion Criteria: - Age 21-65 (inclusive) - If female, 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) Exclusion Criteria: - 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.) - Regular use of indole-3-carbinol or DIM dietary supplements

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
[14C]-benzo[a]pyrene
Oral micro-dose (50 ng) (5.4 nCi)
[14C]-benzo[a]pyrene plus phenanthrene
Oral micro-dose of 50 ng (5.4 nCi) [14C]-benzo[a]pyrene plus 1250 ng phenanthrene

Locations

Country Name City State
United States Oregon State University Corvallis Oregon

Sponsors (4)

Lead Sponsor Collaborator
Oregon State University Lawrence Livermore National Laboratory, National Institute of Environmental Health Sciences (NIEHS), Pacific Northwest National Laboratory

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Plasma and urine 14C-BaP and 14C-BaP metabolite levels after oral dose Plasma and urine levels of 14C-BaP and 14C-BaP metabolites measured by accelerator mass spectrometry 48 hours
Secondary Peak plasma concentration of 14C-BaP Cmax Determination of highest concentration of 14C-BaP in plasma 48 hours
Secondary Time at highest plasma concentration of 14C-BaP Tmax Determination of time at which plasma concentration of 14C-BaP is highest 48 hours
Secondary Area under plasma concentration of 14C-BaP versus time curve AUC Integration of concentration of 14C-BaP in plasma over time 48 hours
Secondary Rate of elimination of 14C-BaP Determination of constants for rate of elimination of 14C-BaP from plasma 48 hours
Secondary Metabolites of 14C-BaP in plasma Determination of plasma metabolites of 14C-BaP 48 hours
Secondary Metabolites of 14C-BaP in urine Determination of urinary metabolites of 14C-BaP 48 hours
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05541653 - The IGNITE Study on Concentrated Investment in Black Neighborhoods N/A
Completed NCT04028791 - Sickle Cell Trait and Exercise, Effect of Hot Environment N/A
Not yet recruiting NCT05105386 - The Impact of Synergies of Indoor Air Pollutants on Childhood Health and Wellbeing
Completed NCT05507944 - FeNO Hairdressers Pilot
Completed NCT04146025 - Nurtured in Nature N/A
Recruiting NCT05179993 - Detection of Microplastics in Human Granulosa Cells and in the Follicular Fluid of Women Undergoing ICSI Treatment
Completed NCT03444922 - Effects of BPA on Insulin and Glucose Responses N/A
Recruiting NCT03319927 - Reducing Pesticide Exposures in Child Care Centers N/A
Recruiting NCT05500690 - Understanding Effects of Folic Acid on the Methylosome and Transcriptome of Women With Spina Bifida Affected Pregnancies N/A
Recruiting NCT05394363 - Generation Victoria Cohort 2020s: A Statewide Longitudinal Cohort Study of Victorian Children and Their Parents
Completed NCT00021658 - Effects of Pesticide Exposure on Neurodevelopment/Growth/Respiratory Health N/A
Not yet recruiting NCT05315388 - Effects of "Vitamin N" Nature Immersion Therapy on Stress Levels in Health Care Workers in the City of Bogotá N/A
Recruiting NCT06107933 - Developmental Impacts of Microplastics Exposure in Early Life
Completed NCT02540408 - Detection and Characterization of COPD in Dairy Farmers N/A
Completed NCT03440307 - Intervention to Reduce Bisphenol A Exposure in Women N/A
Completed NCT05160948 - Change in Knowledge After Receiving Personal Air Pollution Results
Recruiting NCT05865782 - Reconstructing Schoolyards With Greenery to Increase Schoolchildren's Physical Activity and Mitigate Climate Changes N/A
Completed NCT02707172 - Removal of Dermal Exposure to Phthalate Ester by Hand Washing N/A
Active, not recruiting NCT03215368 - The Ma'Anshan Birth Cohort (MABC)
Recruiting NCT06083415 - Early Breast Growth in Girls Aged 6 to 8 Years in the Current Environmental Context N/A