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Benzo[a]Pyrene Ultralow Dose-Response Study

NCT03318978 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2025-05-22

Study results available
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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

Interventions

DRUG

[14C]-benzo[a]pyrene

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

Sponsors & Collaborators

  • National Institute of Environmental Health Sciences (NIEHS)

    collaborator NIH

  • Lawrence Livermore National Laboratory

    collaborator OTHER

  • Pacific Northwest National Laboratory

    collaborator FED

  • Oregon State University

    lead OTHER

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-04-17
Primary Completion
2024-01-01
Completion
2024-02-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03318978 on ClinicalTrials.gov