Nicotine Pharmacokinetic Profile and Safety of the Tobacco Heating System 2.2 Menthol (THS 2.2 Menthol)



Status:Completed
Conditions:Smoking Cessation
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:22 - 65
Updated:3/1/2014
Start Date:October 2013
End Date:May 2014
Contact:James L Borders, MD
Email:jbordersmd@ckrainc.com
Phone:+1-(859) 264 8999

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Trial Summary
Trial Overview
Inclusion Criteria

A Single-center, Randomized, Controlled, Crossover Study to Investigate the Nicotine Pharmacokinetic Profile and Safety of THS 2.2 Menthol Following Single Use in Smokers Compared to Menthol Conventional Cigarettes and Nicotine Nasal Spray

The overall goal of the study is to evaluate the pharmacokinetic (PK) profile (rate and the
amount of nicotine absorbed) following a single use of the THS 2.2 Menthol compared to the
PK profiles from a single use of a menthol conventional cigarette (mCC) and from a single
use of nicotine nasal spray (NNS).


Inclusion Criteria:

- Smoking, healthy subject as judged by the Investigator.

- Subject smokes at least 10 commercially available menthol CCs per day (with brand
restrictions) for the last 4 weeks, based on self reporting.

- Subject has smoked for at least the last 3 consecutive years.

- Subject does not plan to quit smoking in the next 3 months.

Exclusion Criteria:

- As per Investigator judgment, the subject cannot participate in the study for any
reason (e.g., medical, psychiatric, and/or social reason).

- The subject has received medication within 14 days or within 5 half-lives of a drug
(whichever is longer) which has an impact on CYP2A6 activity.

- For women: subject is pregnant or is breast feeding.

- For women: subject does not agree to use an acceptable method of effective
contraception.
We found this trial at
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Central Kentucky Research Associates, Inc.
Lexington, Kentucky 40509
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Lexington, KY
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