N/A
Completed N=62
Nicotine Pharmacokinetic Profile and Safety of the Tobacco Heating System 2.2 Menthol (THS 2.2 Menthol)
Source: ClinicalTrials.gov NCT01967719 ↗Enrolled (actual)
62
Serious AEs
0.0%
Results posted
Feb 2017
Primary outcomePrimary: Maximum Concentration (Cmax) of Nicotine Following Single Use of mTHS 2.2, mCC and NNS — 7.40; 13.08; 8.40; 3.23 ng/mL
Summary
The primary objective of the study is to evaluate the pharmacokinetic (PK) profiles (rate and amount of nicotine absorbed) after a single use of the THS 2.2 Menthol (mTHS 2.2) compared to a single use of the menthol conventional cigarette (mCC) and nicotine nasal spray (NNS).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Concentration (Cmax) of Nicotine Following Single Use of mTHS 2.2, mCC and NNS |
7.40; 13.08; 8.40; 3.23 | — |
| PRIMARY Area Under the Plasma Nicotine Concentration-Time Curve From Time Zero (Pre-product Use) to Last Time Point [AUC(0-last)] Following Single Use of mTHS 2.2, mCC and NNS |
16.53; 29.71; 15.59; 8.72 | — |
Eligibility Criteria
Inclusion Criteria
- Subject is aged from 22 to 65 years (inclusive).
- Smoking, healthy subject as judged by the Investigator.
- Subject smoked at least 10 commercially available menthol CCs per day (with brand restrictions) over the last 4 weeks.
- Subject has smoked for at least the last 3 consecutive years.
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 drug (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 (NCT01967719). 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. Informational only — not medical advice.