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Ultralow Dose PAH Binary Mixture Study

NCT03631667 · 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 a 50 ng dose (5.4 nCi) alone or with 1250 ng phenanthrene.

Conditions

  • Environmental Exposure

Interventions

DRUG

[14C]-benzo[a]pyrene

Oral micro-dose (50 ng) (5.4 nCi)

DRUG

[14C]-benzo[a]pyrene plus phenanthrene

Oral micro-dose of 50 ng (5.4 nCi) \[14C\]-benzo\[a\]pyrene plus 1250 ng phenanthrene

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
2018-10-01
Primary Completion
2024-01-01
Completion
2024-02-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT03631667 on ClinicalTrials.gov