N/A
N=18
Nicotine Pharmacokinetics and Pharmacodynamics, Safety and Tolerability of P3P
Pharmacokinetics
Bottom Line
View on ClinicalTrials.gov: NCT03369340 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcome: Primary: Plasma Nicotine Concentration-time Profile — 0.751; 0.336; 0.205; 0.478 ng/mL
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- P3P 1 (Other); P3P 2 (Other); P3P 3 (Other); P3P 4 (Other)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Philip Morris Products S.A.
- Primary completion
- Feb 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Plasma Nicotine Concentration-time Profile |
1.78; 1.48; 0.945; 1.49; 2.31; 2.27 | — |
| PRIMARY Maximum Plasma Concentration [Cmax] |
3.08; 2.13; 1.14; 2.79 | — |
| PRIMARY Time to the Maximum Nicotine Concentration [Tmax] |
15.0; 22.5; 15.0; 15.0 | — |
| PRIMARY Area Under the Concentration-time Curve From Start of Product Use (T0 Fix) to 4 Hours [AUCfix (0-4h)] |
5.84; 5.08; 2.37; 5.73 | — |
| SECONDARY Plasma Nicotine Concentration-time Profile |
1.78; 1.48; 0.945; 1.49; 2.31; 2.27 | — |
| SECONDARY Peak Plasma Nicotine Concentration [Cpeak] |
5.38; 5.41; 2.63; 4.67 | — |
| SECONDARY Time to Peak Plasma Nicotine Concentration [Tpeak] |
65.0; 82.4; 68.0; 61.9 | — |
| SECONDARY Trough Plasma Nicotine Concentration [Ctrough] |
1.80; 1.58; 1.13; 1.56 | — |
| SECONDARY Average of Plasma Nicotine Concentration From T0 ad Lib to 1 Hour [Caverage] |
3.19; 3.13; 1.69; 2.87 | — |
| SECONDARY Area Under the Concentration-time Curve From Start of Product Use (T0 ad Lib) to 4 Hours [AUCad Lib (0-4h)] |
13.6; 14.5; 6.32; 12.1 | — |
| SECONDARY AUC of Craving for a Cigarette During and After the Fixed Puffing Regimen |
40.1; 57.6; 116; 64.8 | — |
| SECONDARY AUC Craving for a Cigarette During and After the ad Libitum Use Period |
76.4; 72.4; 89.6; 66.8 | — |
| SECONDARY Product Evaluation |
3.22; 4.40; 4.42; 4.13; 2.60; 3.88 | — |
| SECONDARY Sensory Parameters |
3.17; 4.22; 4.22; 3.78; 4.67; 3.61 | — |
| SECONDARY Human Puffing Topography (HPT) Parameters (Puff Volume) of Four P3P Variants During the Fixed Puffing Regimen Period. |
732; 806; 878; 845; 61.0; 66.9 | — |
| SECONDARY Human Puffing Topography (HPT) Parameters (Puff Volume) of Four P3P Variants During the ad Libitum Use Period. |
1485; 1559; 1598; 1512; 57.5; 62.3 | — |
| SECONDARY Amount of Powder Aerosolized From P3P From the Fixed Puffing Regimen. |
954; 965; 966; 965; 938; 944 | — |
| SECONDARY Amount of Powder Aerosolized From P3P From the ad Libitum Use Period (Per Product Used). |
954; 964; 964; 964; 937; 938 | — |
Summary
This is a single-center, open-label, randomized, crossover study to evaluate the pharmacokinetic (PK) profiles of four P3P variants (differing in nicotine aerosol particle size, nicotine concentration and in the absence or presence of a flavoring system), following a fixed puffing regimen and an ad libitum use period. In addition, pharmacodynamic (PD) effects (subjective effects and related behavioral assessments), as well as human puffing topography, will be evaluated, to provide further insights on product safety, acceptance, and use.
Eligibility Criteria
Inclusion criteria
- Subject has signed the Informed Consent Form (ICF) and is able to understand the information provided in the ICF.
- Subject is between 21 and 65 years old.
- Subject is Caucasian.
- Smoking, healthy subject as judged by the Investigator or designee based on available assessments from the screening period.
- Subject has been smoking at least 10 commercially available cigarettes per day at least for the last 4 weeks prior to Screening Visit. Smoking status will be verified based on a urinary cotinine test (cotinine ≥ 200 ng/mL).
- Subject has been smoking for at least the last 3 years prior to Screening Visit.
- Subject does not plan to quit smoking in the next 2 months after the Screening Visit.
Exclusion criteria
- Female subject is pregnant or breastfeeding.
- Female subject uses estrogen-containing hormonal contraception or hormone replacement therapy.
Data sourced from ClinicalTrials.gov (NCT03369340). 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.