Trial · NCT03802721
Pharmacokinetics of Benzo[a]Pyrene: Impact of Diet
NCT03802721, Early phase 1, Completed, Oregon State University; results first posted 2025-05-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pharmacokinetics of Benzo[a]Pyrene: Impact of Diet. Trials, record NCT03802721. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03802721
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pharmacokinetics of Benzo[a]Pyrene: Impact of Diet
- NCT number
- NCT03802721
- Status
- Completed
- Phases
- Early phase 1
- Enrollment
- 7 participants, actual
- Lead sponsor
- Oregon State University
- Conditions
- Environmental Exposure
- Interventions
- [14C]-benzo[a]pyrene, Brussels sprouts before 50 ng dose, DIM supplement before 50 ng dose
- First posted
- 2019-01-14
- Last updated
- 2025-06-22
- Results first posted
- 2025-05-09
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Peak Plasma Concentration of 14C-BaP Cmax | 0-48 hours for each of 3 dosing cycles, with a washout period of 3 weeks between each dosing cycle | Determination of highest concentration of 14C-BaP 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 Cmax. |
| Secondary | Time at Highest Plasma Concentration of 14C-BaP Tmax | 0-48 hours for each of 3 dosing cycles, with a washout period of 3 weeks between each dosing cycle | Determination of time at which plasma concentration of 14C-BaP 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. |
| Secondary | Area Under Plasma Concentration of 14C-BaP Versus Time Curve AUC | 0-48 hours for each of 3 dosing cycles, with a washout period of 3 weeks between each dosing cycle | Integration of concentration of 14C-BaP in plasma 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. |
| Secondary | Rate of Elimination of 14C-BaP (Half Life) | 0-48 hours for each of 3 dosing cycles, with a washout period of 3 weeks between each dosing cycle | Determination of constants for rate of elimination of 14C-BaP 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 half-life. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Peak Plasma Concentration of 14C-BaP Cmax | 0-48 hours for each of 3 dosing cycles, with a washout period of 3 weeks between each dosing cycle | fg [14C]-BaP/mL plasma | MEAN | |
| SECONDARY | Time at Highest Plasma Concentration of 14C-BaP Tmax | 0-48 hours for each of 3 dosing cycles, with a washout period of 3 weeks between each dosing cycle | hour | MEAN | |
| SECONDARY | Area Under Plasma Concentration of 14C-BaP Versus Time Curve AUC | 0-48 hours for each of 3 dosing cycles, with a washout period of 3 weeks between each dosing cycle | fg [14C]-BaP/mL plasma x hour | MEAN | |
| SECONDARY | Rate of Elimination of 14C-BaP (Half Life) | 0-48 hours for each of 3 dosing cycles, with a washout period of 3 weeks between each dosing cycle | hour | MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Peak Plasma Concentration of 14C-BaP Cmax | 50 ng Dose; Brussels Sprouts Before 50 ng Dose; DIM Supplement Before 50 ng Dose | 50 ng [14C] BaP | 3.69 | Standard Deviation 4.12 | fg [14C]-BaP/mL plasma |
| Peak Plasma Concentration of 14C-BaP Cmax | 50 ng Dose; Brussels Sprouts Before 50 ng Dose; DIM Supplement Before 50 ng Dose | Brussels sprouts before 50 ng [14C] BaP | 1.67 | Standard Deviation 1.03 | fg [14C]-BaP/mL plasma |
| Peak Plasma Concentration of 14C-BaP Cmax | 50 ng Dose; Brussels Sprouts Before 50 ng Dose; DIM Supplement Before 50 ng Dose | DIM supplement before 50 ng [14C] BaP | 0.68 | Standard Deviation 0.51 | fg [14C]-BaP/mL plasma |
| Time at Highest Plasma Concentration of 14C-BaP Tmax | 50 ng Dose; Brussels Sprouts Before 50 ng Dose; DIM Supplement Before 50 ng Dose | 50 ng [14C] BaP | 1.58 | Standard Deviation 1.16 | hour |
| Time at Highest Plasma Concentration of 14C-BaP Tmax | 50 ng Dose; Brussels Sprouts Before 50 ng Dose; DIM Supplement Before 50 ng Dose | Brussels sprouts before 50 ng [14C] BaP | 1.14 | Standard Deviation 0.90 | hour |
| Time at Highest Plasma Concentration of 14C-BaP Tmax | 50 ng Dose; Brussels Sprouts Before 50 ng Dose; DIM Supplement Before 50 ng Dose | DIM supplement before | 14.00 | Standard Deviation 19.17 | hour |
| Area Under Plasma Concentration of 14C-BaP Versus Time Curve AUC | 50 ng Dose; Brussels Sprouts Before 50 ng Dose; DIM Supplement Before 50 ng Dose | 50 ng [14C] BaP | 10.93 | Standard Deviation 9.19 | fg [14C]-BaP/mL plasma x hour |
| Area Under Plasma Concentration of 14C-BaP Versus Time Curve AUC | 50 ng Dose; Brussels Sprouts Before 50 ng Dose; DIM Supplement Before 50 ng Dose | Brussels sprouts before 50 ng [14C] BaP | 9.34 | Standard Deviation 10.02 | fg [14C]-BaP/mL plasma x hour |
| Area Under Plasma Concentration of 14C-BaP Versus Time Curve AUC | 50 ng Dose; Brussels Sprouts Before 50 ng Dose; DIM Supplement Before 50 ng Dose | DIM supplement before 50 ng [14C] BaP | 5.51 | Standard Deviation 6.17 | fg [14C]-BaP/mL plasma x hour |
| Rate of Elimination of 14C-BaP (Half Life) | 50 ng Dose; Brussels Sprouts Before 50 ng Dose; DIM Supplement Before 50 ng Dose | 50 ng [14C] BaP | 3.69 | Standard Deviation 3.80 | hour |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 50 ng Dose; Brussels Sprouts Before 50 ng Dose; DIM Supplement Before 50 ng Dose | 7 | |
| Overall Study | COMPLETED | 50 ng Dose; Brussels Sprouts Before 50 ng Dose; DIM Supplement Before 50 ng Dose | 7 | |
| Overall Study | NOT COMPLETED | 50 ng Dose; Brussels Sprouts Before 50 ng Dose; DIM Supplement Before 50 ng Dose | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 50 ng Dose; Brussels Sprouts Before 50 ng Dose; DIM Supplement Before 50 ng Dose | 0 | 7 |
| Total, other adverse events | 50 ng Dose; Brussels Sprouts Before 50 ng Dose; DIM Supplement Before 50 ng Dose | 0 | 7 |
| Total, serious adverse events | 50 ng Dose; Brussels Sprouts Before 50 ng Dose; DIM Supplement Before 50 ng Dose | 0 | 7 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01ES028600 | Benzo[a]pyrene Micro-dosing of Humans: A New Tool for Exposure, Risk Assessment and Prevention | WILLIAMS, DAVID E | OREGON STATE UNIVERSITY | NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES | 2018 to 2022 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03802721
GET https://conductscience.org/api/trials/v1/NCT03802721/registered