N/A
N=60
Product Use and Adaptation, Safety and Tolerability of P3P in Adult Healthy Smokers Switching to it
Pharmacokinetics
Bottom Line
View on ClinicalTrials.gov: NCT03953183 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcome: Primary: Plasma Nicotine Concentration-time Profile — 0.563; 0.563; 0.928; 1.02 ng/ml
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- P3P-1mg (Other); P3P-2mg (Other)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Philip Morris Products S.A.
- Primary completion
- Aug 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Plasma Nicotine Concentration-time Profile |
0.563; 0.563; 0.928; 1.02; 0.982; 1.39 | — |
| PRIMARY Maximum Nicotine Concentration [cCmax] |
1.46; 2.11; 2.05; 2.39 | — |
| PRIMARY Time to the Maximum Nicotine Concentration [cTmax] |
30.0; 30.0; 15.0; 30.0 | — |
| PRIMARY Area Under the Concentration-time Curve From Start of Product Use (T0) to 4 Hours [cAUC(0-4h)] |
3.03; 4.74; 3.96; 5.35 | — |
| SECONDARY Craving for a Cigarette |
138; 111; 130; 109 | — |
| SECONDARY Sensory Parameters |
3.33; 3.50; 4.60; 5.18; 2.33; 3.04 | — |
| SECONDARY Product Experience |
1.25; 1.32; 1.35; 1.45; 4.23; 4.04 | — |
| SECONDARY Product Dependence |
57.9; 59.1; 52.8; 53.0; 45.2; 49.5 | — |
| SECONDARY Product Acceptance |
3.63; 3.46; 3.80; 3.61; 5.27; 5.36 | — |
| SECONDARY Puffing Behavior of Subject |
18; 17; 12; 11; 0; 0 | — |
| SECONDARY Overall Product Use |
6.54; 6.37; 2.64; 2.68; 0.26; 0.25 | — |
| SECONDARY NEQ |
20.3; 30.1; 44.6; 30.4; 41.7; 18.8 | — |
| SECONDARY Total NNAL |
-7.07; -17.1; -8.05; -5.75; 14.3; -14.4 | — |
| SECONDARY CEMA |
-41.1; -27.3; -38.5; -26.0; -18.9; -23.6 | — |
| SECONDARY CYP2A6 Activity |
15.5; 3.19 | — |
| SECONDARY Amount of Powder Extracted From P3P Used for PK Assessment. |
24.1; 22.4; 28.9; 24.2 | — |
Summary
The purpose of the study is to evaluate the product use and adaptation in adult, current cigarette smoking subjects between baseline and after one month of use of one of two P3P variants. The effect of P3P use behavior on nicotine pharmacokinetic (PK) profile, acceptability, as well as the safety and tolerability of P3P over a period of 1 month will be investigated.
Eligibility Criteria
Inclusion Criteria
- Subject has signed and dated the ICF and is able to understand the information provided in it.
- Subject has been a smoker for at least the last 3 years prior to the Screening Visit and has smoked 5 to 15 commercially available cigarettes per day for the last 3 months prior to Screening.
- Subject has a positive urinary cotinine test (cotinine ≥ 200 ng/mL).
- Subject does not plan to quit smoking within 2 months.
- Smoking, healthy subject as judged by the Investigator or designee based on available assessments from the Screening period.
- Ready to switch from smoking cigarettes to using P3P for the duration of the study.
Exclusion Criteria
- As per the Investigator's judgment, the subject cannot participate in the study for any reason other than medical (e.g., psychological and/or social reason).
- Subject has a clinically relevant disease which requires medication or any other clinically significant medical condition, which as per the judgment of the Investigator would jeopardize the safety of the subject.
- Subject has asthma condition (post-bronchodilator FEV1/FVC 200 mL from pre- to post-bronchodilator values).
- Subject has (FEV1/FVC) 32.0 kg/m2.
- Subject has received medication within 14 days or within 5 half-lives of the drug prior to Admission (whichever is longer) which has an impact on CYP2A6 activity.
- Subject has a positive serology test for HIV 1/2, Hepatitis B, or Hepatitis C.
- Subject has a positive alcohol breath test and/or a history of alcohol disorder within the past 2 years.
- Subject has a positive urine drug test.
- Subject has participated in another clinical study within 3 months prior to the Screening Visit.
- Subject has been previously screened or enrolled in this study.
- For women only: subject is pregnant or is breastfeeding.
- For women of childbearing potential only: subject does not agree to use an acceptable method of effective contraception.
Data sourced from ClinicalTrials.gov (NCT03953183). 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.