Validation of a Novel CYP2A6 Phenotyping Probe in Adults

The purpose of the study is to develop a new method for understanding how the body breaks down certain medications by the metabolic enzyme, CYP2A6.  Genetic variations are known to occur with this enzyme and this study will also evaluate the effect of genetic variation on the breakdown of medications through this pathway.

Eligibility Criteria

Healthy, non-smoking adults aged 18-65 taking no medications with a BMI between 18.5-29.9 are invited to participate in this study. 
 
Participants need to refrain from caffeine, tobacco, alcohol and grapefruit juice intake for 48 hours prior to study visits. 
 
Participants need to be off any prescription medication for 14 days prior to study visits. 
 
Participants need to refrain from any over-the-counter medications for 48 hours prior to study visits.
 
•         You would receive a one time, low dose of the antibiotic metronidazole. Blood and urine samples will be collected for 24 hours post-dose (Visit 1); Visit 2 lasts approximately 1 hour and would occur the next day (48 hours after receiving medication) for a single collection of blood and urine
•         You would receive a one time, low dose of nicotine gum (2 mg) to chew for 30 minutes during Visit 3.  Blood and urine samples will be collected for 8 hours post-dose
•         An IV will be placed so that we can draw blood samples without repeated sticks
•         Left over blood may be stored for future research studies
•         There will be at least a 2 week break between the metronidazole and nicotine study days. 
•         You will be randomized to receive either metronidazole or nicotine first. You will be notified of this order when you call to schedule your first visit to be able to plan accordingly
 

Principal Investigator

Steve Leeder and Stephani Stancil

Study Contact

Stephani Stancil (slstancil@cmh.edu)

Estimated Completion Date

Saturday, December 31, 2016
05/27/2016