Environmental ExposureEarly Phase 1NCT03318978

Benzo[a]Pyrene Ultralow Dose-Response Study

A Early Phase 1 study testing [14C]-benzo[a]pyrene in people with Environmental Exposure, run by Oregon State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Evaluation of the pharmacokinetics for [14C]-benzo[a]pyrene ([14C]-BaP) and metabolites in plasma and urine over 48 hours following 4 oral doses of 25, 50, 10 and 250 ng (2.7-27 nCi). Read more about this study

Who is it for?: Ages 21 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Environmental Exposure
What is being tested?: [14C]-benzo[a]pyrene
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 8 participants
Where: 1 siteUnited States
Study dates: 17 Apr 2018to 1 Feb 2024
Phase: Early Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Age 21-65 (inclusive)
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)
Age 21-65 (inclusive)
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)

Who cannot join

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.)

Trial locations and contacts

1 site in 1 country.

United States1 site

Clinical Research Facility, 407 Linus Pauling Science Center, Oregon State University
Corvallis, Oregon, 97331

Other trials in United States

About this study

Evaluation of the pharmacokinetics for [14C]-benzo[a]pyrene ([14C]-BaP) and metabolites in plasma and urine over 48 hours following 4 oral doses of 25, 50, 10 and 250 ng (2.7-27 nCi).

Read the 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 25, 50, 100 or 250 ng (2.7-27 nCi). Metabolite profiles and kinetics of elimination over this dose range 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
Being tested: [14C]-benzo[a]pyrene
Keywords: Benzo[a]pyrene, Accelerator Mass Spectrometry, Polycyclic Aromatic Hydrocarbons

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

[14C]-benzo[a]pyreneDrug
Also called Carcinogenic PAH environmental pollutant
Oral micro-dose range (25, 50, 100 and 250 ng)

Study groups in NCT03318978
Study group	Role	What they receive
25 ng dose, 50 ng dose, 100 ng dose, 250 ng dose	Experimental	Cycle 1: Capsule containing 25 ng (2.7 nCi) [14C]-benzo[a]pyrene (BaP). Cycle 2: Capsule containing 50 ng (2.7 nCi) [14C]-benzo[a]pyrene (BaP). Cycle 3: Capsule containing 100 ng (2.7 nCi) [14C]-benzo[a]pyrene (BaP). Cycle 4: Capsule containing 250 ng (2.7 nCi) [14C]-benzo[a]pyrene (BaP). At least 3 weeks will pass between cycles as a washout period. Receives: Drug: [14C]-benzo[a]pyrene

What is being measured

The primary outcome is the main question the study is designed to answer.

Peak Plasma Concentration Cmax
Determination of highest concentration in plasma. Blood samples collected at 0 (baseline), 0.25, 0.5, 1, 2, 3, 4, 8, 24, and 48 hour after dosing. All time points were used to determine peak plasma concentration Cmax.
Measured: 0-48 hours for each of the 4 dosing cycles with a washout period of 3 weeks between each dosing cycle

Secondary outcomes (3)

Time at Highest Plasma Concentration Tmax
Determination of time at which plasma concentration is highest. Blood samples collected at 0 (baseline), 0.25, 0.5, 1, 2, 3, 4, 8, 24, and 48 hour after dosing. All time points were used to determine Tmax, time at highest plasma concentration.
Measured: 0-48 hours for each of the 4 dosing cycles with a washout period of 3 weeks between each dosing cycle
Area Under Plasma Concentration Versus Time Curve AUC
Integration of concentration over time. Blood samples collected at 0 (baseline), 0.25, 0.5, 1, 2, 3, 4, 8, 24, and 48 hour after dosing. All time points were used to determine AUC.
Measured: 0-48 hours for each of the 4 dosing cycles with a washout period of 3 weeks between each dosing cycle
Rate of Elimination (k1e)
Determination of constants for rate of elimination from plasma. Blood samples collected at 0 (baseline), 0.25, 0.5, 1, 2, 3, 4, 8, 24, and 48 hour after dosing. All time points were used to determine k1e.
Measured: 0-48 hours for each of the 4 dosing cycles with a washout period of 3 weeks between each dosing cycle

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Apr 20181 Feb 2024

First posted24 Oct 2017
Study start17 Apr 2018
Primary completion1 Jan 2024
Study completion1 Feb 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Environmental ExposureStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Early Phase 1
Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03318978
Sponsor's protocol ID: LPI-8233
Other IDs: R01ES028600
Status last verified: May 2025
First submitted: 17 Oct 2017
Last updated: 22 May 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: Deidentified samples sent to Lawrence Livermore National Laboratory Deidentified data sent to Pacific Northwest National Laboratory

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Environmental Exposure trials

Study at a glance

From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Benzo[a]Pyrene Ultralow Dose-Response Study
ClinicalTrials.gov ID: NCT03318978
Acronym / sponsor ID: LPI-8233
Conditions: Environmental Exposure
Keywords: Benzo[a]pyrene, Accelerator Mass Spectrometry, Polycyclic Aromatic Hydrocarbons
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 8 participants (actual)
Lead sponsor: Oregon State UniversityUniversity, hospital or other
Collaborators: National Institute of Environmental Health Sciences (NIEHS), Lawrence Livermore National Laboratory, Pacific Northwest National Laboratory
Study start: 17 Apr 2018 (actual)
Primary completion: 1 Jan 2024 (actual)
Study completion: 1 Feb 2024 (actual)
First posted: 24 Oct 2017 (actual)
Results: Posted 22 May 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Evaluation of the pharmacokinetics for [14C]-benzo[a]pyrene ([14C]-BaP) and metabolites in plasma and urine over 48 hours following 4 oral doses of 25, 50, 10 and 250 ng (2.7-27 nCi).

Detailed description

Study design

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
25 ng dose, 50 ng dose, 100 ng dose, 250 ng dose	Experimental	Drug: [14C]-benzo[a]pyreneCycle 1: Capsule containing 25 ng (2.7 nCi) [14C]-benzo[a]pyrene (BaP). Cycle 2: Capsule containing 50 ng (2.7 nCi) [14C]-benzo[a]pyrene (BaP). Cycle 3: Capsule containing 100 ng (2.7 nCi) [14C]-benzo[a]pyrene (BaP). Cycle 4: Capsule containing 250 ng (2.7 nCi) [14C]-benzo[a]pyrene (BaP). At least 3 weeks will pass between cycles as a washout period.

Who may qualify

Ages: 21 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Age 21-65 (inclusive)
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)

Key exclusion criteria (6 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
[14C]-benzo[a]pyreneAlso: Carcinogenic PAH environmental pollutantOral micro-dose range (25, 50, 100 and 250 ng)	Drug	25 ng dose, 50 ng dose, 100 ng dose, 250 ng dose

Primary outcome

Peak Plasma Concentration Cmax
Time frame: 0-48 hours for each of the 4 dosing cycles with a washout period of 3 weeks between each dosing cycle
Determination of highest concentration in plasma. Blood samples collected at 0 (baseline), 0.25, 0.5, 1, 2, 3, 4, 8, 24, and 48 hour after dosing. All time points were used to determine peak plasma concentration Cmax.

3 secondary outcomes

Time at Highest Plasma Concentration Tmax
Time frame: 0-48 hours for each of the 4 dosing cycles with a washout period of 3 weeks between each dosing cycle
Area Under Plasma Concentration Versus Time Curve AUC
Time frame: 0-48 hours for each of the 4 dosing cycles with a washout period of 3 weeks between each dosing cycle
Rate of Elimination (k1e)
Time frame: 0-48 hours for each of the 4 dosing cycles with a washout period of 3 weeks between each dosing cycle

Results and safety

Results posted to the registry on 22 May 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
25 ng Dose, 50 ng Dose, 100 ng Dose, 250 ng Dose	8	7

Primary outcome: Peak Plasma Concentration Cmax

Time frame: 0-48 hours for each of the 4 dosing cycles with a washout period of 3 weeks between each dosing cycle. Mean (Standard Deviation). Unit: fg [14C]-BaP/mL plasma

Measure	25 ng, 50 ng, 100 ng, and 250 ng Doses n = 7
25 ng [14C]-BaP	2.51 (2.53)
50 ng [14C]-BaP	5.68 (4.70)
100 ng [14C]-BaP	13.8 (9.52)
250 ng [14C]-BaP	8.99 (7.08)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 48.5 hours for each of 4 dosing cycles with a 3-week washout period between each dosing cycle. Participants were assessed for adverse events 15 minutes prior to the [14c]-BaP dose administration (time= 0 hour) until 15 minutes after the final blood sample collection time point (time = 48 hour) and removal of the peripheral IV catheter.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
25 ng Dose, 50 ng Dose, 100 ng Dose, 250 ng Dose	0 of 7 (0%)	0 of 7 (0%)	0 of 7

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. Deidentified samples sent to Lawrence Livermore National Laboratory Deidentified data sent to Pacific Northwest National Laboratory

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing [14C]-benzo[a]pyrene in people with Environmental Exposure, run by Oregon State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Peak Plasma Concentration Cmax (time frame: 0-48 hours for each of the 4 dosing cycles with a washout period of 3 weeks between each dosing cycle). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03318978.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2025.