An Early Phase 1 interventional study of [14C]-benzo[a]pyrene in Environmental Exposure, sponsored by Oregon State University. Completed at 1 site in United States. Open to participants aged 21 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-22.
Sponsored by Oregon State University · Early Phase 1, Interventional, and Basic science
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).
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.
Inclusion Criteria:
Inclusion criteria for women:
Inclusion criteria for men:
Exclusion Criteria:
Exclusion criteria for both men and women:
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.
Drug: [14C]-benzo[a]pyrene
Oral micro-dose range (25, 50, 100 and 250 ng)
Also known as: Carcinogenic PAH environmental pollutant
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.
Time frame: 0-48 hours for each of the 4 dosing cycles with a washout period of 3 weeks between each dosing cycle
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.
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
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.
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)
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.
Time frame: 0-48 hours for each of the 4 dosing cycles with a washout period of 3 weeks between each dosing cycle
| Milestone | 25 ng Dose, 50 ng Dose, 100 ng Dose, 250 ng Dose |
|---|---|
| Started | 8 |
| Completed | 7 |
| Not completed | 1 |
| Withdrew: Withdrawal by subject | 1 |
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.
| fg [14C]-BaP/mL plasma | 25 ng, 50 ng, 100 ng, and 250 ng Doses |
|---|---|
| 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 |
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.
| hour | 25 ng Dose, 50 ng Dose, 100 ng Dose, 250 ng Dose |
|---|---|
| 25 ng [14C]-BaP | 0.5 (0.5 to 4.0) |
| 50 ng [14C]-BaP | 0.5 (0.5 to 1.0) |
| 100 ng [14C]-BaP | 0.5 (0.5 to 1.0) |
| 250 ng [14C]-BaP | 0.5 (0.5 to 3.0) |
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.
| fg [14C]-BaP/mL plasma x hour | 25 ng Dose, 50 ng Dose, 100 ng Dose, 250 ng Dose |
|---|---|
| 25 ng [14C]-BaP | 12.2 ± 14.5 |
| 50 ng [14C]-BaP | 19.6 ± 15.7 |
| 100 ng [14C]-BaP | 88.5 ± 14.1 |
| 250 ng [14C]-BaP | 68.6 ± 60.4 |
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.
| hour(-1) | 25 ng Dose, 50 ng Dose, 100 ng Dose, 250 ng Dose |
|---|---|
| 25 ng [14C]-BaP | 12.2 ± 14.5 |
| 50 ng [14C]-BaP | 19.6 ± 15.7 |
| 100 ng [14C]-BaP | 88.5 ± 14.1 |
| 250 ng [14C]-BaP | 68.6 ± 64.0 |
Collected over 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.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 25 ng Dose, 50 ng Dose, 100 ng Dose, 250 ng Dose | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) |
| Age, Categorical(Participants) | 25 ng Dose, 50 ng Dose, 100 ng Dose, 250 ng Dose |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 8 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | 25 ng Dose, 50 ng Dose, 100 ng Dose, 250 ng Dose |
|---|---|
| Female | 3 |
| Male | 5 |
| Ethnicity (NIH/OMB)(Participants) | 25 ng Dose, 50 ng Dose, 100 ng Dose, 250 ng Dose |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 8 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | 25 ng Dose, 50 ng Dose, 100 ng Dose, 250 ng Dose |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 7 |
| More than one race | 1 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | 25 ng Dose, 50 ng Dose, 100 ng Dose, 250 ng Dose |
|---|---|
| United States | 8 |
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Plan to share: No — Deidentified samples sent to Lawrence Livermore National Laboratory Deidentified data sent to Pacific Northwest National Laboratory
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Oregon State University