N/A
Completed N=62
Nicotine Pharmacokinetic Profile and Safety of the Tobacco Heating System 2.2 (THS 2.2)
Source: ClinicalTrials.gov NCT01967732 ↗Enrolled (actual)
62
Serious AEs
0.0%
Results posted
Aug 2016
Primary outcomePrimary: Maximum Concentration (Cmax) of Nicotine Following Single Use of THS 2.2, CC and NNS — 9.62; 12.42; 10.52; 3.51 ng/mL
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 compared to the PK profiles from a single use of a conventional cigarette (CC) and from a single use of nicotine nasal spray (NNS).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Concentration (Cmax) of Nicotine Following Single Use of THS 2.2, CC and NNS |
9.62; 12.42; 10.52; 3.51 | — |
| 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 THS 2.2, CC and NNS |
15.10; 20.28; 17.87; 8.02 | — |
Eligibility Criteria
Inclusion Criteria
- Subject is Caucasian
- Smoking, healthy subject as judged by the Investigator.
- Subject has smoked at least 10 commercially available non menthol CCs 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 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 (NCT01967732). 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.