MedTrace Logo

Metabolism of NNK in Japanese Americans

NCT04228952 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 16

Last updated 2025-08-01

Study results available
· View outcomes & findings →

Summary

The risk of lung cancer varies by individual and by ethnic/racial group. In this study the investigators will explore how individual differences in the metabolism of a tobacco-specific lung carcinogen may contribute to the variable risk of lung cancer between ethnic/racial groups.

In this 10 day clinical trial, Japanese Americans will smoke a cigarette containing deuterium-labeled 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK), a tobacco-specific lung carcinogen. The study cigarette will be smoked for 7 days.

This will allow for NNK metabolic profiling and determining the effect of CYP2A6 genotype on the level of NNK α-hydroxylation in Japanese Americans smokers using \[pyridine- D4\]-NNK containing cigarettes.

Conditions

  • Smoking

Interventions

COMBINATION_PRODUCT

Modified Natural American Spirit-Tan or Green cigarettes injected with labeled NNK

American Spirit cigarettes will be modified by adding 0.300 μg \[pyridine-D4\]NNK to each cigarette so that the amount of total (deuterated plus unlabeled) NNK in these cigarettes is below 0.700 μg/g tobacco.

Sponsors & Collaborators

  • University of Hawaii

    collaborator OTHER

  • National Cancer Institute (NCI)

    collaborator NIH

  • Masonic Cancer Center, University of Minnesota

    lead OTHER

Principal Investigators

  • Dorothy K Hatsukami, Ph.D · Masonic Cancer Center, University of Minnesota

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2021-10-15
Completion
2025-04-14
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 NCT04228952 on ClinicalTrials.gov