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Polycyclic Aromatic Hydrocarbon
[14C]-benzo[a]pyrene for Environmental Exposures
Phase < 1
Waitlist Available
Research Sponsored by Oregon State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 hours
Awards & highlights
Summary
This trial is evaluating how the body processes a small amount of a chemical called benzo[a]pyrene, given four times at different doses.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 48 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Plasma and urine benzo[a]pyrene and metabolite levels after oral dose
Secondary outcome measures
Area under plasma concentration versus time curve AUC
Metabolites in plasma
Metabolites in urine
+3 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: 50 ng doseExperimental Treatment1 Intervention
Capsule containing 50 ng (2.7 nCi) [14C]-benzo[a]pyrene (BaP)
Group II: 250 ng doseExperimental Treatment1 Intervention
Capsule containing 100 ng (2.7 nCi) [14C]-benzo[a]pyrene (BaP)
Group III: 25 ng doseExperimental Treatment1 Intervention
Capsule containing 25 ng (2.7 nCi) [14C]-benzo[a]pyrene (BaP)
Group IV: 100 ng doseExperimental Treatment1 Intervention
Capsule containing 100 ng (2.7 nCi) [14C]-benzo[a]pyrene (BaP)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
[14C]-benzo[a]pyrene
2018
Completed Early Phase 1
~20
Find a Location
Who is running the clinical trial?
Oregon State UniversityLead Sponsor
50 Previous Clinical Trials
8,438 Total Patients Enrolled
3 Trials studying Environmental Exposures
452 Patients Enrolled for Environmental Exposures
National Institute of Environmental Health Sciences (NIEHS)NIH
286 Previous Clinical Trials
1,232,645 Total Patients Enrolled
12 Trials studying Environmental Exposures
4,758 Patients Enrolled for Environmental Exposures
Pacific Northwest National LaboratoryFED
9 Previous Clinical Trials
3,768 Total Patients Enrolled
2 Trials studying Environmental Exposures
12 Patients Enrolled for Environmental Exposures
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been exposed to certain chemicals (found in jobs like roofing, paving, and firefighting) that can increase the risk of developing a certain type of lung disease.You have a history of stomach or intestinal surgery, or you have certain digestive disorders like Crohn's disease, celiac disease, IBS, or colitis.You take medications that can affect how your stomach and intestines work or how your body absorbs nutrients.You currently have or have had kidney or liver problems in the past.
Research Study Groups:
This trial has the following groups:- Group 1: 100 ng dose
- Group 2: 25 ng dose
- Group 3: 250 ng dose
- Group 4: 50 ng dose
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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