N/A
N=36
Nicotine Pharmacokinetics Following Use of the P4M3 Gen 2.0 E-Cigarette Compared to Smoking Cigarettes
Nicotine Vaping · Nicotine · Vaping
Bottom Line
View on ClinicalTrials.gov: NCT05383508 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcome: Primary: Background-corrected Maximum Plasma Concentration [Cmax] — 2.934; 3.365; 17.49 (ng/mL)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CA35 (Other); CM35 (Other); Cig (Other)
- Age
- Adult, Older Adult · 24+ yrs
- Sex
- All
- Sponsor
- Philip Morris Products S.A.
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Background-corrected Maximum Plasma Concentration [Cmax] |
2.934; 3.365; 17.49 | — |
| PRIMARY Background-corrected Time to the Maximum Concentration [Tmax] |
109.3; 37.79; 7.826 | — |
| PRIMARY Area Under the Background-corrected Concentration-time Curve From Start of Product Use to Time of Last Quantifiable Concentration and Extrapolated to Infinity. |
891.1; 655.6; 2484 | — |
| PRIMARY Maximum Ratio of Background-corrected Concentration Over Time |
0.3547; 0.5150; 3.239 | — |
Summary
This is a single-center, randomized, controlled, open-label, cross-over study with healthy adult smokers. The study will investigate the nicotine pharmacokinetic (PK) profiles of two e-liquid variants used with the P4M3 Gen 2.0 e-cigarette, compared to smoking combustible cigarettes.
In addition, pharmacodynamic (PD) effects (subjective effects and related behavioral assessments), will be evaluated to provide further insights on product evaluation, craving, liking, puffing topography. The study will be conducted with three periods and six sequences in a cross-over design.
This study is exploratory and there is no pre-specified hypothesis to be tested.
Eligibility Criteria
Inclusion Criteria
- Subject has signed the ICF and is able to understand the information provided in the ICF.
- Subject has smoked continuously for at least the last 3 years prior to the Screening visit.
- Subject has smoked ≥ 10 commercially available cigarettes per day for 4 weeks prior to Screening Visit and Admission.
- Subject does not plan to quit smoking cigarettes or using other nicotine or tobacco containing products in the next 3 months.
- Smoking, healthy subject as judged by the Investigator or designee based on available assessments from the Screening period.
Exclusion Criteria
- As per the Investigator's judgment, the subject cannot participate in the study for any reason other than medical.
- Subject has donated or received whole blood or blood products within 30 days prior to Screening Visit.
- BMI 35.0 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 history of alcohol abuse that could interfere with the subject's participation in study.
- Subject has a positive urine drug test.
- Subject has a positive alcohol breath test.
- Subject has participated in another clinical study within 30 days prior to the Screening Visit.
- Subject is pregnant (does not have negative pregnancy tests at Screening Visit and at Admission) 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 (NCT05383508). 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.