N/A
N=62
Nicotine Pharmacokinetic Profile and Safety of the Tobacco Heating System 2.2 Menthol (THS 2.2 Menthol).
Smoking
Bottom Line
View on ClinicalTrials.gov: NCT01967706 ↗Enrolled (actual)
62
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcome: Primary: Maximum Concentration (Cmax) of Nicotine Following Single Use of mTHS, mCC and NRT — 10.70; 12.09; 7.64; 7.52 ng/mL
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- mTHS (Other); mCC (Other); NRT (Other)
- Age
- Adult, Older Adult · 23+ yrs
- Sex
- All
- Sponsor
- Philip Morris Products S.A.
- Primary completion
- Nov 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Concentration (Cmax) of Nicotine Following Single Use of mTHS, mCC and NRT |
10.70; 12.09; 7.64; 7.52 | — |
| PRIMARY Area Under the Plasma Concentration-Time Curve From Time Zero (Pre-product Use) to Last Time Point [AUC(0-last)] Following Single Use of mTHS, mCC and NRT |
23.99; 24.45; 15.61; 27.94 | — |
Summary
The primary objective of this clinical study is to evaluate the pharmacokinetic (PK) profile (rate and amount of nicotine absorbed) following a single use of the THS 2.2 Menthol (mTHS), a candidate Modified Risk Tobacco Product, compared to the PK profiles from a single use of a menthol cigarette (mCC) and from a single use of nicotine replacement therapy gum (NRT).
Eligibility Criteria
Inclusion Criteria
- Subject is Japanese.
- Smoking, healthy subject as judged by the Investigator.
- Subject has smoked at least 10 commercially available mCCs per day (no brand restrictions) for the last 4 weeks.
- 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).
- Subject has received medication within 14 days or within 5 half-lives of a medication (whichever is longer) which has an impact on CYP2A6 activity.
- Female subject is pregnant or breast feeding.
- Female subject does not agree to use an acceptable method of effective contraception.
Data sourced from ClinicalTrials.gov (NCT01967706). 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.