Benzo[a]Pyrene Ultralow Dose-Response Study

NCT03318978 | Completed Early Phase 1 Results FDA Drug

• 2 other identifiers: LPI-8233R01ES028600
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Environmental Exposure

Keywords

Benzo[a]pyrene; Accelerator Mass Spectrometry; Polycyclic Aromatic Hydrocarbons

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  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)

  0-48 hours for each of the 4 dosing cycles with a washout period of 3 weeks between each dosing cycle

Study Arms (1)

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.

Drug: [14C]-benzo[a]pyrene

Interventions

[14C]-benzo[a]pyrene DRUG

Oral micro-dose range (25, 50, 100 and 250 ng)

Also known as: Carcinogenic PAH environmental pollutant

25 ng dose, 50 ng dose, 100 ng dose, 250 ng dose

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• Occupational PAH exposure (e.g. roofers, asphalt pavers, fire-fighters, etc.)

Sponsors & Collaborators

• Oregon State University: lead
• National Institute of Environmental Health Sciences (NIEHS): collaborator
• Lawrence Livermore National Laboratory: collaborator
• Pacific Northwest National Laboratory: collaborator

Study Sites (1)

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

Corvallis, Oregon, 97331, United States

Location

Results Point of Contact

• Title: David E. Williams, PhD
• Organization: Oregon State University

david.williams@oregonstate.edu

541-737-3277

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: Deidentified samples will be analyzed by AMS at Lawrence Livermore National Laboratory and the pharmacokinetics determine at Pacific Northwest National Laboratory.
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Helen P. Rumbel Professor for Cancer Prevention

Study Record Dates

• First Submitted: October 17, 2017
• First Posted: October 24, 2017
• Study Start: April 17, 2018
• Primary Completion: January 1, 2024
• Study Completion: February 1, 2024
• Last Updated: May 22, 2025
• Results First Posted: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)