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

NCT05383508 | Completed Results

• 1 other identifier: P4-PK-04-US
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Nicotine Vaping; Nicotine; Vaping

Keywords

Nicotine; Pharmacokinetics; Smoking; Cigarette; E-Cigarette

Outcome Measures

Primary Outcomes (4)

• Background-corrected Maximum Plasma Concentration [Cmax]

  To measure Cmax from 6 minutes ad libitum use for two e-liquid variants used with the P4M3 Gen 2.0 e-cigarette and for subjects smoking cigarettes.

  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.)

• Background-corrected Time to the Maximum Concentration [Tmax]

  To measure Tmax from 6 minutes ad libitum use for two e-liquid variants used with the P4M3 Gen 2.0 e-cigarette and for subjects smoking cigarettes.

  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.)

• Area Under the Background-corrected Concentration-time Curve From Start of Product Use to Time of Last Quantifiable Concentration and Extrapolated to Infinity.

  To measure the area under the background-corrected concentration-time curve (AUC) from start of product use from 6 minutes ad libitum use for two e-liquid variants used with the P4M3 Gen 2.0 e-cigarette and for subjects smoking cigarettes.

  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.)

• Maximum Ratio of Background-corrected Concentration Over Time

  To measure the maximum ratio of background-corrected concentration over time, from T0 (excluded) to Tmax (included)

  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.)

Study Arms (6)

Product Sequence 1

ACTIVE COMPARATOR

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

Other: CA35; Other: CM35; Other: Cig

Product Sequence 2

ACTIVE COMPARATOR

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

Other: CA35; Other: CM35; Other: Cig

Product Sequence 3

ACTIVE COMPARATOR

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

Other: CA35; Other: CM35; Other: Cig

Product Sequence 4

ACTIVE COMPARATOR

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

Other: CA35; Other: CM35; Other: Cig

Product Sequence 5

ACTIVE COMPARATOR

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

Other: CA35; Other: CM35; Other: Cig

Product Sequence 6

ACTIVE COMPARATOR

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

Other: CA35; Other: CM35; Other: Cig

Interventions

CA35 OTHER

Nicotine concentration: 3.5 % e-liquid flavor: Tobacco

Also known as: P4M3 variant CA35

Product Sequence 1; Product Sequence 2; Product Sequence 3; Product Sequence 4; Product Sequence 5; Product Sequence 6

CM35 OTHER

Nicotine concentration: 3.5 % e-liquid flavor: Menthol

Also known as: P4M3 variant CM35

Product Sequence 1; Product Sequence 2; Product Sequence 3; Product Sequence 4; Product Sequence 5; Product Sequence 6

Cig OTHER

Subjects' preferred brand of commercially available, regular or mentholated cigarettes

Product Sequence 1; Product Sequence 2; Product Sequence 3; Product Sequence 4; Product Sequence 5; Product Sequence 6

Eligibility Criteria

• Age: 24 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Philip Morris Products S.A.: lead

Study Sites (1)

High Point Clinical Trials Center (HPCTC)

High Point, North Carolina, 27265, United States

Location

MeSH Terms

Conditions

Vaping; Smoking

Interventions

Fibronectins

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Membrane Glycoproteins; Glycoproteins; Glycoconjugates; Carbohydrates; Serum Globulins; Globulins; Proteins; Amino Acids, Peptides, and Proteins; Membrane Proteins; Extracellular Matrix Proteins; Scleroproteins

Results Point of Contact

• Title: Christelle Haziza, Global Head Clinical Research and Execution
• Organization: Philip Morris Products S.A.

ClinicalTrials.PMI@pmi.com

+41 58 242 11 11

Study Officials

• Melanie Fein, MD

  High Point Clinical Trials Center (HPCTC)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2022
• First Posted: May 20, 2022
• Study Start: April 28, 2022
• Primary Completion: June 29, 2022
• Study Completion: August 25, 2022
• Last Updated: April 26, 2024
• Results First Posted: April 26, 2024

Record last verified: 2024-04

Locations

US (1)