N/A
N=48
Nicotine Pharmacokinetic Profile of the CHTP 1.1 M
Smoking
Bottom Line
View on ClinicalTrials.gov: NCT02466412 ↗Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcome: Primary: Maximum Concentration (Cmax) of Nicotine Following Single Use of CHTP 1.1 M and mCC — 6.2950; 9.8463 ng/mL
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CHTP 1.1 M (Other); mCC (Other)
- Age
- Adult, Older Adult · 23+ yrs
- Sex
- All
- Sponsor
- Philip Morris Products S.A.
- Primary completion
- Aug 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Concentration (Cmax) of Nicotine Following Single Use of CHTP 1.1 M and mCC |
6.2950; 9.8463 | — |
| PRIMARY Area Under the Plasma Concentration Versus Time Curve From Time Zero (Pre-product Use) to Last Time Point [AUC(0-last)] Following Single Use of CHTP 1.1 M and mCC |
8.5311; 14.2172 | — |
Summary
The primary objective of this clinical study is to evaluate the pharmacokinetic (PK) profile of nicotine (rate and amount of nicotine absorbed) after single use of the Carbon Heated Tobacco Product 1.1 Menthol (CHTP 1.1 M), a potential Modified Risk Tobacco Product, compared to menthol cigarettes (mCC) in healthy smokers.
Eligibility Criteria
Inclusion Criteria
- Subject is Japanese.
- Subject is at a minimum 23 years of age.
- Smoking, healthy subject as judged by the Investigator.
- Subject has smoked for at least the last 3 years
- Subject smoked at least 10 commercially available mCCs per day over the last 4 weeks.
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 (NCT02466412). 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.