PharmacokineticsNCT03953183

Product Use and Adaptation, Safety and Tolerability of P3P in Adult Healthy Smokers Switching to it

A study testing P3P-1mg and P3P-2mg in people with Pharmacokinetics, run by Philip Morris Products S.A. at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 21 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Pharmacokinetics
What is being tested?: P3P-1mg and P3P-2mg
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteRussia
Study dates: 23 Apr 2019to 25 Oct 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Subject has signed and dated the ICF and is able to understand the information provided in it.
Subject has been a smoker for at least the last 3 years prior to the Screening Visit and has smoked 5 to 15 commercially available cigarettes per day for the last 3 months prior to Screening.
Subject has a positive urinary cotinine test (cotinine ≥ 200 ng/mL).
Subject does not plan to quit smoking within 2 months.
Smoking, healthy subject as judged by the Investigator or designee based on available assessments from the Screening period.
Ready to switch from smoking cigarettes to using P3P for the duration of the study.

Who cannot join

As per the Investigator's judgment, the subject cannot participate in the study for any reason other than medical (e.g., psychological and/or social reason).
Subject has a clinically relevant disease which requires medication or any other clinically significant medical condition, which as per the judgment of the Investigator would jeopardize the safety of the subject.
Subject has asthma condition (post-bronchodilator FEV1/FVC < 0.75 and reversibility in FEV1 ≥ 12% and > 200 mL from pre- to post-bronchodilator values).
Subject has (FEV1/FVC) < 0.7 and FEV1 < 80% predicted value at post-bronchodilator spirometry.
Subject has a BMI < 18.5 kg/m2 or > 32.0 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.

Show all 13Show fewer

Subject has a positive serology test for HIV 1/2, Hepatitis B, or Hepatitis C.
Subject has a positive alcohol breath test and/or a history of alcohol disorder within the past 2 years.
Subject has a positive urine drug test.
Subject has participated in another clinical study within 3 months prior to the Screening Visit.
Subject has been previously screened or enrolled in this study.
For women only: subject is pregnant or is breastfeeding.
For women of childbearing potential only: subject does not agree to use an acceptable method of effective contraception.

Trial locations and contacts

1 site in 1 country.

Russia1 site

LLC Scientific Research Center Eco-Safety
Saint Petersburg, 196143

Other trials in Russia

About this study

Official title: A Randomized, Double-blinded, 2-arm Parallel Groups, Single Center Study to Assess Product Use and Adaptation, Safety and Tolerability of P3P, a Novel Nicotine-containing Product, in Adult Healthy Cigarette Smokers Switching to One of Two P3P Variants for One Month

The purpose of the study is to evaluate the product use and adaptation in adult, current cigarette smoking subjects between baseline and after one month of use of one of two P3P variants. The effect of P3P use behavior on nicotine pharmacokinetic (PK) profile, acceptability, as well as the safety and tolerability of P3P over a period of 1 month will be investigated.

Read the detailed description

This is a study of daily use of up to 15 P3P products over one month, including 2 confinement periods (2 overnight stays at the beginning of the study and 1 overnight stay at the end of the exposure period). During the confinement visits, nicotine PK from P3P exposure will be assessed as well as pharmacodynamic effects related to craving, sensory parameters, product experience, and product acceptance.

Between the two confinement periods, subjects will return to the investigational site for weekly ambulatory visits during which P3P will be resupplied and selected safety and other study assessments will be performed.

From the start of the exposure period onwards, subjects will be instructed not to smoke or use other tobacco or nicotine containing products and to use P3P exclusively.

Conditions: Pharmacokinetics
Being tested: P3P-1mg, P3P-2mg
Keywords: Nicotine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

P3P-1mgOther
P3P-1mg (P3P product containing 1mg of nicotine.)
P3P-2mgOther
P3P-2mg (P3P product containing 2mg of nicotine.)

Study groups in NCT03953183
Study group	Role	What they receive
P3P-1mg	Other	Subjects randomized to exclusive use of P3P-1mg Receives: Other: P3P-1mg
P3P-2mg	Other	Subjects randomized to exclusive use of P3P-2mg Receives: Other: P3P-2mg

What is being measured

The primary outcome is the main question the study is designed to answer.

Plasma Nicotine Concentration-time Profile
To measure the plasma nicotine concentration-time profile following correction of baseline nicotine levels.
Measured: Derived from multiple blood sampling pre- and post-product use (over 4 hours post-product use), on day 1 and day 30.
Maximum Nicotine Concentration [cCmax]
To measure the maximum plasma nicotine concentration [cCmax] following correction of baseline nicotine levels.
Measured: Derived from multiple blood sampling pre- and post-product use (over 4 hours post-product use), on day 1 and day 30.
Time to the Maximum Nicotine Concentration [cTmax]
To measure the time to maximum nicotine concentration [cTmax] following correction of baseline nicotine levels.
Measured: Derived from multiple blood sampling pre- and post-product use (over 4 hours post-product use), on day 1 and day 30.
Area Under the Concentration-time Curve From Start of Product Use (T0) to 4 Hours [cAUC(0-4h)]
To measure the area under the plasma concentration-time curve [cAUC(0-4h)] following correction of baseline nicotine levels.
Measured: Derived from multiple blood sampling pre- and post-product use (over 4 hours post-product use), on day 1 and day 30.

Secondary outcomes (12)

Craving for a Cigarette
Measured on a Visual Analogue Scale (VAS) of 0 (no craving) to 100 (strong craving). Over time results calculated as area under curve mm*hour.
Measured: Before, during and up to 4 hours post-product use on day 1 and day 30
Sensory Parameters
Measured with a Sensory Questionnaire. Response to each question is assessed on a 7-point scale, ranging from 1 (not at all) to 7 (extremely).
Measured: Within 60 minutes after product use on day 1 and day 30.
Product Experience
Measured with ABOUT[TM]-Product Experience questionnaire. Response to each question is assessed on a 7-point scale, ranging from 1 (not at all) to 7 (extremely).
Measured: Within 60 minutes after product use on day 1 and day 30.
Product Dependence
Measured with ABOUT[TM]-Dependence questionnaire. Response to each question is assessed on a 5-point scale, ranging from 1 (not at all/never) to 5 (extremely/all the time) or a 6-point scale ranging from 0 (more than 3 hours) to 5 (0-5 minutes).
Measured: Within 60 minutes after product use on day 1 and day 30.
Product Acceptance
Measured with a Product Acceptance questionnaire. Response to each question is assessed on a 7-point scale, ranging from 1 (most negative) to 7 (most positive) or as multiple choice questions.
Measured: Within 60 minutes after product use on day 1 and day 30.
Puffing Behavior of Subject
To measure changes in subject puffing behavior. Evaluated by selection of one puffing behavior response out of three possible responses.
- 1. Puffing and holding the aerosol in the mouth for a short time and then inhaling (i.e. like a cigarette)
- 2. Puffing and immediately inhaling (without holding the aerosol in the mouth)
- 3. Puffing and immediately exhaling, without inhalation
Measured: Evaluated by site staff on day 1 and day 30. Self-evaluated by subject on day 2, day 7, day 15, day 22, and day 29.
Overall Product Use
To assess the number of any nicotine/tobacco products used overall on a daily basis.
Measured: Recorded daily by subject, in product use diary, from day 1 until day 30.
NEQ
To measure percent changes from baseline in Nicotine equivalents (NEQ) concentrations, measured in spot urine and expressed as concentration adjusted for creatinine.
Measured: Measured at baseline, day 7, day 15, day 22, and day 29.
Total NNAL
To measure percent changes from baseline in total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) concentrations, measured in spot urine and expressed as concentration adjusted for creatinine.
Measured: Measured at baseline, day 7, day 15, day 22, and day 29.
CEMA
To measure percent changes from baseline in 2-cyanoethylmercapturic acid (CEMA) concentrations, measured in spot urine and expressed as concentration adjusted for creatinine (ng/mg creat).
Measured: Measured at baseline, day 7, day 15, day 22, and day 29.
CYP2A6 Activity
To measure percent change from baseline in CYP2A6 enzymatic activity, on day 30, as measured by molar metabolic ratio of trans-3-hydroxy-cotinine/cotinine in plasma.
Measured: Measured before product use, on day 1 and day 30.
Amount of Powder Extracted From P3P Used for PK Assessment.
Weight difference (mg) of P3P before and after use, to determine the amount of powder extracted from P3P.
Measured: Before and after product use, on day 1 and day 30.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Apr 201925 Oct 2019

First posted16 May 2019
Study start23 Apr 2019
Primary completion14 Aug 2019
Study completion25 Oct 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for PharmacokineticsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Model description: A randomized, double-blinded, 2-arm parallel groups, single center study
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03953183
Sponsor's protocol ID: P3P-SE-02-RU
Status last verified: Nov 2020
First submitted: 15 May 2019
Last updated: 14 Dec 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Chrea C, Acquadro C, Afolalu EF, Spies E, Salzberger T, Abetz-Webb L, Cano S, Arnould B, Mainy N, Rose J, Weitkunat R. Developing fit-for-purpose self-report instruments for assessing consumer responses to tobacco and nicotine products: the ABOUT Toolbox initiative. F1000Res. 2018 Dec 2;7:1878. doi: 10.12688/f1000research.16810.1. eCollection 2018.
PubMed 30906527

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 14 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blinded, 2-arm Parallel Groups, Single Center Study to Assess Product Use and Adaptation, Safety and Tolerability of P3P, a Novel Nicotine-containing Product, in Adult Healthy Cigarette Smokers Switching to One of Two P3P Variants for One Month
ClinicalTrials.gov ID: NCT03953183
Acronym / sponsor ID: P3P-SE-02-RU
Conditions: Pharmacokinetics
Keywords: Nicotine
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Philip Morris Products S.A.Industry (pharma, biotech, devices)
Study start: 23 Apr 2019 (actual)
Primary completion: 14 Aug 2019 (actual)
Study completion: 25 Oct 2019 (actual)
First posted: 16 May 2019 (actual)
Results: Posted 14 Dec 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

From the start of the exposure period onwards, subjects will be instructed not to smoke or use other tobacco or nicotine containing products and to use P3P exclusively.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2
Model description: A randomized, double-blinded, 2-arm parallel groups, single center study

Arm	Type	Receives
P3P-1mg	Other	Other: P3P-1mgSubjects randomized to exclusive use of P3P-1mg
P3P-2mg	Other	Other: P3P-2mgSubjects randomized to exclusive use of P3P-2mg

Who may qualify

Ages: 21 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Subject has signed and dated the ICF and is able to understand the information provided in it.
Subject has been a smoker for at least the last 3 years prior to the Screening Visit and has smoked 5 to 15 commercially available cigarettes per day for the last 3 months prior to Screening.
Subject has a positive urinary cotinine test (cotinine ≥ 200 ng/mL).
Subject does not plan to quit smoking within 2 months.
Smoking, healthy subject as judged by the Investigator or designee based on available assessments from the Screening period.

Key exclusion criteria (13 listed)

As per the Investigator's judgment, the subject cannot participate in the study for any reason other than medical (e.g., psychological and/or social reason).
Subject has a clinically relevant disease which requires medication or any other clinically significant medical condition, which as per the judgment of the Investigator would jeopardize the safety of the subject.
Subject has asthma condition (post-bronchodilator FEV1/FVC < 0.75 and reversibility in FEV1 ≥ 12% and > 200 mL from pre- to post-bronchodilator values).
Subject has (FEV1/FVC) < 0.7 and FEV1 < 80% predicted value at post-bronchodilator spirometry.
Subject has a BMI < 18.5 kg/m2 or > 32.0 kg/m2.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
P3P-1mgP3P-1mg (P3P product containing 1mg of nicotine.)	Other	P3P-1mg
P3P-2mgP3P-2mg (P3P product containing 2mg of nicotine.)	Other	P3P-2mg

Primary outcome

Plasma Nicotine Concentration-time Profile
Time frame: Derived from multiple blood sampling pre- and post-product use (over 4 hours post-product use), on day 1 and day 30.
To measure the plasma nicotine concentration-time profile following correction of baseline nicotine levels.
Maximum Nicotine Concentration [cCmax]
Time frame: Derived from multiple blood sampling pre- and post-product use (over 4 hours post-product use), on day 1 and day 30.
To measure the maximum plasma nicotine concentration [cCmax] following correction of baseline nicotine levels.
Time to the Maximum Nicotine Concentration [cTmax]
Time frame: Derived from multiple blood sampling pre- and post-product use (over 4 hours post-product use), on day 1 and day 30.
To measure the time to maximum nicotine concentration [cTmax] following correction of baseline nicotine levels.
Area Under the Concentration-time Curve From Start of Product Use (T0) to 4 Hours [cAUC(0-4h)]
Time frame: Derived from multiple blood sampling pre- and post-product use (over 4 hours post-product use), on day 1 and day 30.
To measure the area under the plasma concentration-time curve [cAUC(0-4h)] following correction of baseline nicotine levels.

12 secondary outcomes

Craving for a Cigarette
Time frame: Before, during and up to 4 hours post-product use on day 1 and day 30
Sensory Parameters
Time frame: Within 60 minutes after product use on day 1 and day 30.
Product Experience
Time frame: Within 60 minutes after product use on day 1 and day 30.
Product Dependence
Time frame: Within 60 minutes after product use on day 1 and day 30.
Product Acceptance
Time frame: Within 60 minutes after product use on day 1 and day 30.
Puffing Behavior of Subject
Time frame: Evaluated by site staff on day 1 and day 30. Self-evaluated by subject on day 2, day 7, day 15, day 22, and day 29.
Overall Product Use
Time frame: Recorded daily by subject, in product use diary, from day 1 until day 30.
NEQ
Time frame: Measured at baseline, day 7, day 15, day 22, and day 29.
Total NNAL
Time frame: Measured at baseline, day 7, day 15, day 22, and day 29.
CEMA
Time frame: Measured at baseline, day 7, day 15, day 22, and day 29.
CYP2A6 Activity
Time frame: Measured before product use, on day 1 and day 30.
Amount of Powder Extracted From P3P Used for PK Assessment.
Time frame: Before and after product use, on day 1 and day 30.

Results and safety

Results posted to the registry on 14 Dec 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
P3P-1mg	30	30
P3P-2mg	30	28

Primary outcome: Plasma Nicotine Concentration-time Profile

Time frame: Derived from multiple blood sampling pre- and post-product use (over 4 hours post-product use), on day 1 and day 30.. Geometric mean (95% Confidence Interval). Unit: ng/ml

Measure	P3P-1mg n = 30	P3P-2mg n = 28
4 mins after start of product use (Day 1)	0.563 (0.384 to 0.824)	0.563 (0.370 to 0.858)
7 mins after start of product use (Day 1)	0.928 (0.635 to 1.36)	1.02 (0.688 to 1.51)
10 mins after start of product use (Day 1)	0.982 (0.699 to 1.38)	1.39 (0.949 to 2.03)
15 mins after start of product use (Day 1)	1.18 (0.914 to 1.54)	1.58 (1.14 to 2.20)
30 mins after start of product use (Day 1)	1.24 (0.969 to 1.60)	1.59 (1.09 to 2.34)
1 hr after start of product use (Day 1)	1.07 (0.850 to 1.34)	1.45 (1.04 to 2.02)
2 hr after start of product use (Day 1)	0.702 (0.546 to 0.904)	1.08 (0.824 to 1.41)
4 hr after start of product use (Day 1)	0.353 (0.272 to 0.458)	0.570 (0.416 to 0.781)

Population analysed: Some participants were excluded from analysis for protocol deviations. For participants in whom the elimination rate constant could not be calculated for any of the visits, background-corrected nicotine concentrations were considered as missing.

Primary outcome: Maximum Nicotine Concentration [cCmax]

Time frame: Derived from multiple blood sampling pre- and post-product use (over 4 hours post-product use), on day 1 and day 30.. Geometric mean (95% Confidence Interval). Unit: ng/mL

Measure	P3P-1mg n = 30	P3P-2mg n = 28
Day 1	1.46 (1.12 to 1.89)	2.11 (1.62 to 2.75)
Day 30	2.05 (1.69 to 2.48)	2.39 (1.73 to 3.32)

Primary outcome: Time to the Maximum Nicotine Concentration [cTmax]

Time frame: Derived from multiple blood sampling pre- and post-product use (over 4 hours post-product use), on day 1 and day 30.. Median (95% Confidence Interval). Unit: minutes

Measure	P3P-1mg n = 30	P3P-2mg n = 28
Day 1	30.0 (15.0 to 30.0)	30.0 (15.0 to 30.0)
Day 30	15.0 (10.0 to 30.0)	30.0 (15.0 to 60.0)

Primary outcome: Area Under the Concentration-time Curve From Start of Product Use (T0) to 4 Hours [cAUC(0-4h)]

Time frame: Derived from multiple blood sampling pre- and post-product use (over 4 hours post-product use), on day 1 and day 30.. Geometric mean (95% Confidence Interval). Unit: ng*hour/mL

Measure	P3P-1mg n = 30	P3P-2mg n = 28
Day 1	3.03 (2.34 to 3.92)	4.74 (3.64 to 6.19)
Day 30	3.96 (3.29 to 4.78)	5.35 (3.85 to 7.43)

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, for a total study duration of up to 45 days for each subject.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
P3P-1mg	0 of 30 (0%)	7 of 30 (23.3%)	0 of 30
P3P-2mg	0 of 30 (0%)	5 of 30 (16.7%)	0 of 30

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 30906527Chrea C, Acquadro C, Afolalu EF, Spies E, Salzberger T, Abetz-Webb L, Cano S, Arnould B, Mainy N, Rose J, Weitkunat R. Developing fit-for-purpose self-report instruments for assessing consumer responses to tobacco and nicotine products: the ABOUT Toolbox initiative. F1000Res. 2018 Dec 2;7:1878. doi: 10.12688/f1000research.16810.1. eCollection 2018.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Christelle Haziza, PhD study chair

Philip Morris Products SA

Vasilyuk V Bogdanovich, MD principal investigator

LLC Scientific Research Center Eco-Safety

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing P3P-1mg and P3P-2mg in people with Pharmacokinetics, run by Philip Morris Products S.A. at 1 site in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Plasma Nicotine Concentration-time Profile (time frame: Derived from multiple blood sampling pre- and post-product use (over 4 hours post-product use), on day 1 and day 30.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03953183, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2020; AzTrials last refreshed its copy on 8 Nov 2026.