Ignite Creation Date:
2024-05-06 @ 2:09 PM
Last Modification Date:
2024-10-26 @ 1:26 PM
Study NCT ID:
NCT04228952
Status:
RECRUITING
Last Update Posted:
2024-02-28
First Post:
2020-01-09
Brief Title:
Metabolism of NNK in Japanese Americans
Sponsor:
Masonic Cancer Center University of Minnesota
Organization:
Masonic Cancer Center University of Minnesota
Study Overview
Official Title:
STUDY 2 CLINICAL PROTOCOL Metabolism of NNK Among Japanese Americans
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The risk of lung cancer varies by individual and by ethnicracial 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 ethnicracial 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
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
Detailed Description:
Eligible subjects will provide a baseline 24 hour urine sample Study cigarettes spiked with labeled NNK will be provided to the subjects to smoke over a 7 day period During this time 24 hour urine samples will be collected over days 5 6 and 7 on study cigarettes Blood will be drawn on days 6 and 7 on study cigarettes Samples will be analyzed for NNK metabolism
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P01CA138338 | NIH | None | httpsreporternihgovquickSearchP01CA138338 |