N/A
N=16
Metabolism of NNK in Japanese Americans
Smoking
Bottom Line
View on ClinicalTrials.gov: NCT04228952 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: The Ratio of D4-hydroxy Acid to D4- NNAL (an Estimate if NNK Alpha Hydroxylation) — 0.133; 0.175 Ratio
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Modified Natural American Spirit-Tan or Green cigarettes injected with labeled NNK (Combination_product)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Masonic Cancer Center, University of Minnesota
- Primary completion
- Oct 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Ratio of D4-hydroxy Acid to D4- NNAL (an Estimate if NNK Alpha Hydroxylation) |
0.133; 0.175 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Japanese American - one, but preferably 2 biological parents of Japanese descent
- 21 years or older
- Daily smoker
- Eligible urinary ratios of total 3-hydroxycotinine to cotinine (3HC/COT):
- "Little or no-CYP2A6 activity" defined as a 3-hydroxycotinine:cotinine ratio of 3.0.
- Stable and good physical and mental health
- Provided written informed consent to participate in the study
Exclusion Criteria
- Unwilling to avoid other nicotine containing products during the study and no use of any nicotine-containing products except cigarettes for 1 week prior to their study visits
- Currently taking any medications that affect relevant metabolic enzymes
- Experiencing medical conditions that might affect biomarkers of exposure and effect
- Pregnant or nursing or planning on becoming pregnant during the study
- Unable to read and understand English
Data sourced from ClinicalTrials.gov (NCT04228952). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.