N/A
Completed N=16
Nicotine Pharmacokinetic and Pharmacodynamics Profile, Safety and Tolerability of P3L
Source: ClinicalTrials.gov NCT02532374 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcomePrimary: Maximum Concentration (Cmax) of Nicotine Following Single Use of Nicorette® Inhalator — 6.095 ng/mL
Summary
The purpose of this study is to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD, i.e., subjective effects) profiles, and the safety and tolerability of the nicotine-containing aerosol delivered by Platform 3 Liquid (P3L) system at three different nicotine levels in smoking healthy subjects in relation to Nicorette® inhalator.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Concentration (Cmax) of Nicotine Following Single Use of Nicorette® Inhalator |
6.095 | — |
| PRIMARY Maximum Concentration (Cmax) of Nicotine Following Single Use of P3L 50 µg/Puff |
9.659 | — |
| PRIMARY Maximum Concentration (Cmax) of Nicotine Following Single Use of P3L 80 µg/Puff |
11.145 | — |
| PRIMARY Maximum Concentration (Cmax) of Nicotine Following Single Use of P3L 150 µg/Puff |
9.805 | — |
| PRIMARY Time to the Maximum Concentration (Tmax) of Nicotine Following Single Use of Nicorette® Inhalator |
30.0 | — |
| PRIMARY Time to the Maximum Concentration (Tmax) of Nicotine Following Single Use of P3L 50 µg/Puff |
7.0 | — |
| PRIMARY Time to the Maximum Concentration (Tmax) of Nicotine Following Single Use of P3L 80 µg/Puff |
7.0 | — |
| PRIMARY Time to the Maximum Concentration (Tmax) of Nicotine Following Single Use of P3L 150 µg/Puff |
7.0 | — |
| PRIMARY Area Under the Concentration-time Curve From Start of Product Use to the Last Quantifiable Time Point (AUC0-last) of Nicotine Following Single Use of Nicorette® Inhalator |
12.323 | — |
| PRIMARY Area Under the Concentration-time Curve From Start of Product Use to the Last Quantifiable Time Point (AUC0-last) of Nicotine Following Single Use of P3L 50 µg/Puff |
9.943 | — |
| PRIMARY Area Under the Concentration-time Curve From Start of Product Use to the Last Quantifiable Time Point (AUC0-last) of Nicotine Following Single Use of P3L 80 µg/Puff |
10.259 | — |
| PRIMARY Area Under the Concentration-time Curve From Start of Product Use to the Last Quantifiable Time Point (AUC0-last) of Nicotine Following Single Use of P3L 150 µg/Puff |
9.983 | — |
| PRIMARY Area Under the Concentration-time Curve From Start of Product Use to 10 Minutes After Start of Product Use (AUC0-10) of Nicotine Following Single Use of Nicorette® Inhalator |
0.124 | — |
| PRIMARY Area Under the Concentration-time Curve From Start of Product Use to 10 Minutes After Start of Product Use (AUC0-10) of Nicotine Following Single Use of P3L 50 µg/Puff |
1.028 | — |
| PRIMARY Area Under the Concentration-time Curve From Start of Product Use to 10 Minutes After Start of Product Use (AUC0-10) of Nicotine Following Single Use of P3L 80 µg/Puff |
1.157 | — |
| PRIMARY Area Under the Concentration-time Curve From Start of Product Use to 10 Minutes After Start of Product Use (AUC0-10) of Nicotine Following Single Use of P3L 150 µg/Puff |
1.040 | — |
Eligibility Criteria
Inclusion Criteria
- Subject is Caucasian
- Smoking, healthy subject as judged by the Investigator
- Subject smoked at least 10 commercially available non-menthol cigarettes (CCs) per day for the last 4 weeks
- Subject has smoked for at least the last 3 years prior to screening
- 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 donated or been in receipt of whole blood or blood products within 3 months prior to Admission Visit
- Female subject is pregnant or breast feeding
- Female subject does not agree to use an acceptable method of effective contraception
- Female subject uses estrogen-containing hormonal contraception or hormone replacement therapy
Data sourced from ClinicalTrials.gov (NCT02532374). 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.