Nicotine Pharmacokinetics Following Use of the P4M3 Gen 2.0 E-Cigarette Compared to Smoking Cigarettes

Philip Morris

Status: Completed

Conditions: Nicotine; Nicotine Vaping; Vaping

Treatments: Other: CM35; Other: Cig; Other: CA35

Study type: Interventional

Funder types: Industry

Identifiers

NCT05383508

P4-PK-04-US

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 24 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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36 participants in 6 patient groups

Product Sequence 1

Active Comparator group

Description:

After at least 12 hours of abstinence from the use of any nicotine/tobacco containing products (referred to as nicotine wash-out), subjects will smoke a cigarette or use one of the e-liquid variants with P4M3 Gen 2.0 according to randomized product use sequence ad libitum for 6 minutes (± 30 seconds). CA35 on Day 1; Cig on Day 2; CM35 on Day 3

Treatment:

Other: Cig

Other: CA35

Other: CM35

Product Sequence 2

Active Comparator group

Description:

After at least 12 hours of abstinence from the use of any nicotine/tobacco containing products (referred to as nicotine wash-out), subjects will smoke a cigarette or use one of the e-liquid variants with P4M3 Gen 2.0 according to randomized product use sequence ad libitum for 6 minutes (± 30 seconds). CA35 on Day 1; CM35 on Day 2; Cig on Day 3

Treatment:

Other: Cig

Other: CA35

Other: CM35

Product Sequence 3

Active Comparator group

Description:

After at least 12 hours of abstinence from the use of any nicotine/tobacco containing products (referred to as nicotine wash-out), subjects will smoke a cigarette or use one of the e-liquid variants with P4M3 Gen 2.0 according to randomized product use sequence ad libitum for 6 minutes (± 30 seconds). Cig on Day 1; CA35 on Day 2; CM35 on Day 3

Treatment:

Other: Cig

Other: CA35

Other: CM35

Product Sequence 4

Active Comparator group

Description:

After at least 12 hours of abstinence from the use of any nicotine/tobacco containing products (referred to as nicotine wash-out), subjects will smoke a cigarette or use one of the e-liquid variants with P4M3 Gen 2.0 according to randomized product use sequence ad libitum for 6 minutes (± 30 seconds). Cig on Day 1; CM35 on Day 2; CA35 on Day 3

Treatment:

Other: Cig

Other: CA35

Other: CM35

Product Sequence 5

Active Comparator group

Description:

After at least 12 hours of abstinence from the use of any nicotine/tobacco containing products (referred to as nicotine wash-out), subjects will smoke a cigarette or use one of the e-liquid variants with P4M3 Gen 2.0 according to randomized product use sequence ad libitum for 6 minutes (± 30 seconds). CM35 on Day 1; Cig on Day 2; CA35 on Day 3

Treatment:

Other: Cig

Other: CA35

Other: CM35

Product Sequence 6

Active Comparator group

Description:

After at least 12 hours of abstinence from the use of any nicotine/tobacco containing products (referred to as nicotine wash-out), subjects will smoke a cigarette or use one of the e-liquid variants with P4M3 Gen 2.0 according to randomized product use sequence ad libitum for 6 minutes (± 30 seconds). CM35 on Day 1; CA35 on Day 2; Cig on Day 3

Treatment:

Other: Cig

Other: CA35

Other: CM35