Environmental Exposure Clinical Trial
Official title:
Ultralow Dose PAH Binary Mixture Study
Verified date | February 2024 |
Source | Oregon State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Oregon State University | Corvallis | Oregon |
Lead Sponsor | Collaborator |
---|---|
Oregon State University | Lawrence Livermore National Laboratory, National Institute of Environmental Health Sciences (NIEHS), Pacific Northwest National Laboratory |
United States,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
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