Reduced Exposure Study Using THS 2.2 Menthol With 5 Days in a Confinement Setting Followed by 86 Days in an Ambulatory Setting
Completed · Not applicable
Conditions studied: Smoking
In brief
Evaluate if the ad libitum use of the THS 2.2 Menthol (mTHS), a candidate Modified Risk Tobacco Product, for 5 days in confinement, and after 86 days in an ambulatory setting, by apparently adult healthy smokers results in a reduction in the levels of biomarkers of exposure (BoExp) to selected harmful and potentially harmful constituents (HPHCs).
Key facts
- Study ID
- NCT01989156
- Run by
- Philip Morris Products S.A.
- People needed
- 160
- Starts
- 2013-12-01
- Expected to finish
- 2015-05-01
- Last updated by the study team
- 2020-03-24
Who can join
Age: 22 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Smoking, apparently healthy subject as judged by the Investigator.
- Subject smokes at least 10 commercially available mCCs per day (no 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 within the next 6 months.
You may not qualify if…
- 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 the medication (whichever is longer), which has an impact on CYP1A2 or 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.
Where it is running
- Covance Daytona Beach, 1900 Mason Ave., Suite 140 — Daytona Beach, Florida, United States
- Covance Dallas, 1341 W. Mockingbird Ln., Ste 400E — Dallas, Texas, United States
Full record on ClinicalTrials.gov
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