Clinical trial NCT05383508: Nicotine Pharmacokinetics Following Use of the P4M3 Gen 2.0 E-Cigarette Compared to Smoking Cigarettes
Official title: A Single-center, Randomized, Controlled, Open-label, Cross-over Study in Healthy Subjects to Investigate the Nicotine Pharmacokinetic Profiles of 2 Variants of P4M3 Gen 2.0, an Electronic Nicotine Delivery System, Compared to Cigarettes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nicotine Vaping
Nicotine
Vaping
Keywords: Nicotine
Pharmacokinetics
Smoking
Cigarette
E-Cigarette
Lead sponsor: Philip Morris Products S.A.
Sponsor class: INDUSTRY
First posted: 2022-05-20
Enrollment: 36
Sex: ALL
Minimum age (years): 24
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief 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.

Detailed description: The purpose of the study is to evaluate the nicotine pharmacokinetics (PK) profiles of two e-liquid variants used with the P4M3 Gen 2.0 e-cigarette versus cigarettes following a six minutes ad libitum use period. In addition, pharmacodynamic effects (PD), including subjective effects and related behavioral assessments, as well as human puffing topography (HPT) will be evaluated, to provide further insights on P4M3 Gen 2.0 product acceptance and product use. Safety will be assessed throughout the study.

The aim is to evaluate if P4M3 Gen 2.0 can provide an acceptable alternative to smoking cigarettes in terms of both, nicotine delivery and sensorial satisfaction for current adult smokers who would otherwise continue smoking cigarettes.

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 \< 18.5 kg/m2 or \> 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.

Primary outcomes:
measure: Background-corrected Maximum Plasma Concentration [Cmax]
timeFrame: T0 = start of product use. From day 1 to day 3, blood was drawn 5 minutes prior to T0 (day 1 only), and then 1, 2, 4, 6, 8, 10, 12, 15, 30 minutes, 1, 2, 4, 10 and 24 hours after T0. (Note that sample taken 24 hours after T0 on day 1 and day 2 only.)
measure: Background-corrected Time to the Maximum Concentration [Tmax]
timeFrame: T0 = start of product use. From day 1 to day 3, blood was drawn 5 minutes prior to T0 (day 1 only), and then 1, 2, 4, 6, 8, 10, 12, 15, 30 minutes, 1, 2, 4, 10 and 24 hours after T0. (Note that sample taken 24 hours after T0 on day 1 and day 2 only.)
measure: Area Under the Background-corrected Concentration-time Curve From Start of Product Use to Time of Last Quantifiable Concentration and Extrapolated to Infinity.
timeFrame: T0 = start of product use. From day 1 to day 3, blood was drawn 5 minutes prior to T0 (day 1 only), and then 1, 2, 4, 6, 8, 10, 12, 15, 30 minutes, 1, 2, 4, 10 and 24 hours after T0. (Note that sample taken 24 hours after T0 on day 1 and day 2 only.)
measure: Maximum Ratio of Background-corrected Concentration Over Time
timeFrame: T0 = start of product use. From day 1 to day 3, blood was drawn 5 minutes prior to T0 (day 1 only), and then 1, 2, 4, 6, 8, 10, 12, 15, 30 minutes, 1, 2, 4, 10 and 24 hours after T0. (Note that sample taken 24 hours after T0 on day 1 and day 2 only.)
Secondary outcomes:
Other outcomes:
Locations:
city: High Point
country: United States
facility: High Point Clinical Trials Center (HPCTC)
state: North Carolina
Study officials:
affiliation: High Point Clinical Trials Center (HPCTC)
name: Melanie Fein, MD
role: PRINCIPAL_INVESTIGATOR
References: