Nicotine Pharmacokinetics Following Use of the P4M3 Gen 2.0 E-Cigarette Compared to Smoking Cigarettes
NCT ID: NCT05383508
Last Updated: 2024-04-26
Study Results
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View full resultsBasic Information
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COMPLETED
NA
36 participants
INTERVENTIONAL
2022-04-28
2022-08-25
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
NONE
Study Groups
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Product Sequence 1
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
CA35
Nicotine concentration: 3.5 % e-liquid flavor: Tobacco
CM35
Nicotine concentration: 3.5 % e-liquid flavor: Menthol
Cig
Subjects' preferred brand of commercially available, regular or mentholated cigarettes
Product Sequence 2
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
CA35
Nicotine concentration: 3.5 % e-liquid flavor: Tobacco
CM35
Nicotine concentration: 3.5 % e-liquid flavor: Menthol
Cig
Subjects' preferred brand of commercially available, regular or mentholated cigarettes
Product Sequence 3
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
CA35
Nicotine concentration: 3.5 % e-liquid flavor: Tobacco
CM35
Nicotine concentration: 3.5 % e-liquid flavor: Menthol
Cig
Subjects' preferred brand of commercially available, regular or mentholated cigarettes
Product Sequence 4
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
CA35
Nicotine concentration: 3.5 % e-liquid flavor: Tobacco
CM35
Nicotine concentration: 3.5 % e-liquid flavor: Menthol
Cig
Subjects' preferred brand of commercially available, regular or mentholated cigarettes
Product Sequence 5
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
CA35
Nicotine concentration: 3.5 % e-liquid flavor: Tobacco
CM35
Nicotine concentration: 3.5 % e-liquid flavor: Menthol
Cig
Subjects' preferred brand of commercially available, regular or mentholated cigarettes
Product Sequence 6
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
CA35
Nicotine concentration: 3.5 % e-liquid flavor: Tobacco
CM35
Nicotine concentration: 3.5 % e-liquid flavor: Menthol
Cig
Subjects' preferred brand of commercially available, regular or mentholated cigarettes
Interventions
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CA35
Nicotine concentration: 3.5 % e-liquid flavor: Tobacco
CM35
Nicotine concentration: 3.5 % e-liquid flavor: Menthol
Cig
Subjects' preferred brand of commercially available, regular or mentholated cigarettes
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
24 Years
65 Years
ALL
Yes
Sponsors
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Philip Morris Products S.A.
INDUSTRY
Responsible Party
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Principal Investigators
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Melanie Fein, MD
Role: PRINCIPAL_INVESTIGATOR
High Point Clinical Trials Center (HPCTC)
Locations
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High Point Clinical Trials Center (HPCTC)
High Point, North Carolina, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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P4-PK-04-US
Identifier Type: -
Identifier Source: org_study_id
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