PharmacokineticsNCT03369340

Nicotine Pharmacokinetics and Pharmacodynamics, Safety and Tolerability of P3P

A study testing P3P 1, P3P 2 and P3P 3 in people with Pharmacokinetics, run by Philip Morris Products S.A. at 1 site in Switzerland.

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 1, P3P 2 and P3P 3
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 19 participants
Where: 1 siteSwitzerland
Study dates: 7 Nov 2017to 2 May 2018
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 the Informed Consent Form (ICF) and is able to understand the information provided in the ICF.
Subject is between 21 and 65 years old.
Subject is Caucasian.
Smoking, healthy subject as judged by the Investigator or designee based on available assessments from the screening period.
Subject has been smoking at least 10 commercially available cigarettes per day at least for the last 4 weeks prior to Screening Visit. Smoking status will be verified based on a urinary cotinine test (cotinine ≥ 200 ng/mL).
Subject has been smoking for at least the last 3 years prior to Screening Visit.
Subject does not plan to quit smoking in the next 2 months after the Screening Visit.

Who cannot join

Female subject is pregnant or breastfeeding.
Female subject uses estrogen-containing hormonal contraception or hormone replacement therapy.

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

CROSS Research
Arzo, Canton Ticino, 6864

Other trials in Switzerland

About this study

Official title: A Single-center, Open-label, Randomized, Crossover Study to Investigate the Nicotine Pharmacokinetic Profile, Pharmacodynamics, Safety and Tolerability of Four P3P Variants in Smoking Healthy Adult Subjects

This is a single-center, open-label, randomized, crossover study to evaluate the pharmacokinetic (PK) profiles of four P3P variants (differing in nicotine aerosol particle size, nicotine concentration and in the absence or presence of a flavoring system), following a fixed puffing regimen and an ad libitum use period. In addition, pharmacodynamic (PD) effects (subjective effects and related behavioral assessments), as well as human puffing topography, will be evaluated, to provide further insights on product safety, acceptance, and use.

Read the detailed description

The goal of the proposed study is to evaluate the pharmacokinetic profiles of four P3P variants. Variants with two different nicotine contents (1 mg/product and 2 mg/product), two different nicotine aersol particle sizes and presence/absence of a flavoring system will be tested to identify which one would yield plasma nicotine concentrations as close as possible to those achieved after smoking a single cigarette. All of the subjects will initially use the lowest nicotine content product (P3P 3). Subject will continue the study using the three remaining products (P3P 1, P3P 2 and P3P 4) containing 2 mg nicotine/product in a randomly assigned sequence.

Two product use regimens: fixed puffing and ad libitum use will be applied to provide insight into nicotine absorption. The fixed puffing regimen with consistent use conditions across subjects will be applied in order to minimize variability. The 1 hour ad libitum use period will provide information on nicotine PK and product acceptance when subjects use the P3P according to their own puffing behavior which is closer to a real-world setting.

Safety and tolerability will also be assessed throughout the study.

Conditions: Pharmacokinetics
Being tested: P3P 1, P3P 2, P3P 3, P3P 4
Keywords: Nicotine, Nicotine-containing product

What participants receive

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

P3P 1Other
2 mg of nicotine; no flavor; nicotine powder particle size of 2.25 ± 0.2 μm
P3P 2Other
2 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm
P3P 3Other
1 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm
P3P 4Other
2 mg of nicotine; flavor; nicotine powder particle size of 1.8 ± 0.2 μm

Study groups in NCT03369340
Study group	Role	What they receive
Product Sequence 1	Active comparator	Subjects will be exposed to P3P 3 on day 1 of the study, then randomized to follow a sequence of product exposure comprised of: P3P 2 on Day 2; P3P 4 on Day 3; P3P 1 on Day 4 Receives: Other: P3P 1; Other: P3P 2; Other: P3P 3; Other: P3P 4
Product Sequence 2	Active comparator	Subjects will be exposed to P3P 3 on day 1 of the study, then randomized to follow a sequence of product exposure comprised of: P3P 4 on Day 2; P3P 1 on Day 3; P3P 2 on Day 4 Receives: Other: P3P 1; Other: P3P 2; Other: P3P 3; Other: P3P 4
Product Sequence 3	Active comparator	Subjects will be exposed to P3P 3 on day 1 of the study, then randomized to follow a sequence of product exposure comprised of: P3P 1 on Day 2; P3P 2 on Day 3; P3P 4 on Day 4 Receives: Other: P3P 1; Other: P3P 2; Other: P3P 3; Other: P3P 4
Product Sequence 4	Active comparator	Subjects will be exposed to P3P 3 on day 1 of the study, then randomized to follow a sequence of product exposure comprised of: P3P 1 on Day 2; P3P 4 on Day 3; P3P 2 on Day 4 Receives: Other: P3P 1; Other: P3P 2; Other: P3P 3; Other: P3P 4
Product Sequence 5	Active comparator	Subjects will be exposed to P3P 3 on day 1 of the study, then randomized to follow a sequence of product exposure comprised of: P3P 2 on Day 2; P3P 1 on Day 3; P3P 4 on Day 4 Receives: Other: P3P 1; Other: P3P 2; Other: P3P 3; Other: P3P 4
Product Sequence 6	Active comparator	Subjects will be exposed to P3P 3 on day 1 of the study, then randomized to follow a sequence of product exposure comprised of: P3P 4 on Day 2; P3P 2 on Day 3; P3P 1 on Day 4 Receives: Other: P3P 1; Other: P3P 2; Other: P3P 3; Other: P3P 4

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 of four P3P variants from the fixed puffing regimen, following correction of baseline nicotine levels.
Measured: Derived from multiple blood sampling (measured at 2 mins, 4 mins, 7 mins, 10 mins, 15 mins, 30 mins, 1 hour, 2 hours, and 4 hours post-product use) on Days 1, 2, 3 and 4
Maximum Plasma Concentration [Cmax]
To measure the maximum nicotine plasma concentration [Cmax] of four P3P variants from the fixed puffing regimen, following correction of baseline nicotine levels.
Measured: Derived from multiple blood sampling (measured at 2 mins, 4 mins, 7 mins, 10 mins, 15 mins, 30 mins, 1 hour, 2 hours, and 4 hours post-product use) on Days 1, 2, 3 and 4
Time to the Maximum Nicotine Concentration [Tmax]
To measure the time to maximum nicotine concentration [Tmax] of four P3P variants from the fixed puffing regimen, following correction of baseline nicotine levels.
Measured: Derived from multiple blood sampling (measured at 2 mins, 4 mins, 7 mins, 10 mins, 15 mins, 30 mins, 1 hour, 2 hours, and 4 hours post-product use) on Days 1, 2, 3 and 4
Area Under the Concentration-time Curve From Start of Product Use (T0 Fix) to 4 Hours [AUCfix (0-4h)]
To measure the area under the plasma concentration-time curve of four P3P variants from the fixed puffing regimen, following correction of baseline nicotine levels.
Measured: Derived from multiple blood sampling (measured at 2 mins, 4 mins, 7 mins, 10 mins, 15 mins, 30 mins, 1 hour, 2 hours, and 4 hours post-product use) on Days 1, 2, 3 and 4

Secondary outcomes (14)

Plasma Nicotine Concentration-time Profile
To measure the plasma nicotine concentration-time profile of four P3P variants from the ad libitum use period, following correction of baseline nicotine levels.
Measured: Derived from multiple blood sampling (measured at 10 mins, 20 mins, 30 mins, 40 mins, 1 hour, 2 hours, and 4 hours during and post-ad libitum use) on Days 1, 2, 3 and 4
Peak Plasma Nicotine Concentration [Cpeak]
To measure the Peak plasma nicotine concentration [Cpeak] of four P3P variants from the ad libitum use period, following correction of baseline nicotine levels.
Measured: Derived from multiple blood sampling (measured at 10 mins, 20 mins, 30 mins, 40 mins, 1 hour, 2 hours, and 4 hours during and post-ad libitum use) on Days 1, 2, 3 and 4
Time to Peak Plasma Nicotine Concentration [Tpeak]
To measure the time to peak plasma nicotine concentration [Tpeak] of four P3P variants from the ad libitum use period, following correction of baseline nicotine levels.
Measured: Derived from multiple blood sampling (measured at 10 mins, 20 mins, 30 mins, 40 mins, 1 hour, 2 hours, and 4 hours during and post-ad libitum use) on Days 1, 2, 3 and 4
Trough Plasma Nicotine Concentration [Ctrough]
To measure the trough plasma nicotine concentration [Ctrough] of four P3P variants from the ad libitum use period, following correction of baseline nicotine levels.
Measured: Derived from multiple blood sampling (measured at 10 mins, 20 mins, 30 mins, 40 mins, 1 hour, 2 hours, and 4 hours during and post-ad libitum use) on Days 1, 2, 3 and 4
Average of Plasma Nicotine Concentration From T0 ad Lib to 1 Hour [Caverage]
To measure the average of plasma nicotine concentration [Caverage], of four P3P variants from the ad libitum use period, following correction of baseline nicotine levels
Measured: Derived from multiple blood sampling (measured at 10 mins, 20 mins, 30 mins, 40 mins, 1 hour during ad libitum use) on Days 1, 2, 3 and 4
Area Under the Concentration-time Curve From Start of Product Use (T0 ad Lib) to 4 Hours [AUCad Lib (0-4h)]
To measure the area under the plasma concentration-time curve of four P3P variants from the ad libitum use period, following correction of baseline nicotine levels.
Measured: Derived from multiple blood sampling (measured at 10 mins, 20 mins, 30 mins, 40 mins, 1 hour, 2 hours, and 4 hours during and post-ad libitum use) on Days 1, 2, 3 and 4
AUC of Craving for a Cigarette During and After the Fixed Puffing Regimen
Measured on a Visual Analogue Scale (VAS) of 0 (no craving) to 100 (strong craving).
Measured: During and up to 4 hours post-product use on days 1, 2, 3 and 4
AUC Craving for a Cigarette During and After the ad Libitum Use Period
Measured on a Visual Analogue Scale (VAS) of 0 (no craving) to 100 (strong craving).
Measured: During and up to 4 hours post-product use on days 1, 2, 3 and 4
Product Evaluation
Measured with an adapted version of the modified Cigarette Evaluation Questionnaire (adapted mCEQ) following the ad libitum use period. Assessed on a 7-point scale, ranging from 1 (not at all) to 7 (extremely).
Measured: Within 60 minutes after the ad libitum use session on days 1, 2, 3 and 4
Sensory Parameters
Measured with a Sensory Questionnaire (SQ) following the ad libitum use period. 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 the ad libitum use session on days 1, 2, 3 and 4
Human Puffing Topography (HPT) Parameters (Puff Volume) of Four P3P Variants During the Fixed Puffing Regimen Period.
Descriptive statistics of total puff volume and average puff volume, of four P3P variants, during the fixed puffing regimen period.
Measured: During fixed puffing product use on days 1, 2, 3 and 4
Human Puffing Topography (HPT) Parameters (Puff Volume) of Four P3P Variants During the ad Libitum Use Period.
Descriptive statistics of total puff volume and average puff volume, of four P3P variants, during the ad libitum use period.
Measured: During ad libitum product use on days 1, 2, 3 and 4
Amount of Powder Aerosolized From P3P From the Fixed Puffing Regimen.
Descriptive statistics of P3P weight before use, and after use, for the fixed puffing regimen.
Measured: Before and after fixed puffing product use on days 1, 2, 3 and 4
Amount of Powder Aerosolized From P3P From the ad Libitum Use Period (Per Product Used).
P3P weight before use, and after use, to determine the amount of powder aerosolized from P3P during Ad Libitum use (per product used).
Measured: Before and after ad libitum product use on days 1, 2, 3 and 4

Timeline

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

7 Nov 20172 May 2018

First posted12 Dec 2017
Study start7 Nov 2017
Primary completion1 Feb 2018
Study completion2 May 2018

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.
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: Other
Allocation: Randomised
Intervention model: Crossover
Model description: A single-center, open-label, randomized, crossover study.
Masking: None (open label)
Enrolment: 19 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03369340
Sponsor's protocol ID: P3P-PK-01-CH
Status last verified: Jan 2020
First submitted: 22 Nov 2017
Last updated: 31 Jan 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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 31 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-center, Open-label, Randomized, Crossover Study to Investigate the Nicotine Pharmacokinetic Profile, Pharmacodynamics, Safety and Tolerability of Four P3P Variants in Smoking Healthy Adult Subjects
ClinicalTrials.gov ID: NCT03369340
Acronym / sponsor ID: P3P-PK-01-CH
Conditions: Pharmacokinetics
Keywords: Nicotine, Nicotine-containing product
Study type: Interventional
Recruitment status: Completed
Enrolment: 19 participants (actual)
Lead sponsor: Philip Morris Products S.A.Industry (pharma, biotech, devices)
Study start: 7 Nov 2017 (actual)
Primary completion: 1 Feb 2018 (actual)
Study completion: 2 May 2018 (actual)
First posted: 12 Dec 2017 (actual)
Results: Posted 31 Jan 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

Safety and tolerability will also be assessed throughout the study.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 6
Model description: A single-center, open-label, randomized, crossover study.

Arm	Type	Receives
Product Sequence 1	Active comparator	Other: P3P 1, Other: P3P 2, Other: P3P 3, Other: P3P 4Subjects will be exposed to P3P 3 on day 1 of the study, then randomized to follow a sequence of product exposure comprised of: P3P 2 on Day 2; P3P 4 on Day 3; P3P 1 on Day 4
Product Sequence 2	Active comparator	Other: P3P 1, Other: P3P 2, Other: P3P 3, Other: P3P 4Subjects will be exposed to P3P 3 on day 1 of the study, then randomized to follow a sequence of product exposure comprised of: P3P 4 on Day 2; P3P 1 on Day 3; P3P 2 on Day 4
Product Sequence 3	Active comparator	Other: P3P 1, Other: P3P 2, Other: P3P 3, Other: P3P 4Subjects will be exposed to P3P 3 on day 1 of the study, then randomized to follow a sequence of product exposure comprised of: P3P 1 on Day 2; P3P 2 on Day 3; P3P 4 on Day 4
Product Sequence 4	Active comparator	Other: P3P 1, Other: P3P 2, Other: P3P 3, Other: P3P 4Subjects will be exposed to P3P 3 on day 1 of the study, then randomized to follow a sequence of product exposure comprised of: P3P 1 on Day 2; P3P 4 on Day 3; P3P 2 on Day 4
Product Sequence 5	Active comparator	Other: P3P 1, Other: P3P 2, Other: P3P 3, Other: P3P 4Subjects will be exposed to P3P 3 on day 1 of the study, then randomized to follow a sequence of product exposure comprised of: P3P 2 on Day 2; P3P 1 on Day 3; P3P 4 on Day 4
Product Sequence 6	Active comparator	Other: P3P 1, Other: P3P 2, Other: P3P 3, Other: P3P 4Subjects will be exposed to P3P 3 on day 1 of the study, then randomized to follow a sequence of product exposure comprised of: P3P 4 on Day 2; P3P 2 on Day 3; P3P 1 on Day 4

Who may qualify

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

Key inclusion criteria (7 listed)

Subject has signed the Informed Consent Form (ICF) and is able to understand the information provided in the ICF.
Subject is between 21 and 65 years old.
Subject is Caucasian.
Smoking, healthy subject as judged by the Investigator or designee based on available assessments from the screening period.
Subject has been smoking at least 10 commercially available cigarettes per day at least for the last 4 weeks prior to Screening Visit. Smoking status will be verified based on a urinary cotinine test (cotinine ≥ 200 ng/mL).

Key exclusion criteria (2 listed)

Female subject is pregnant or breastfeeding.
Female subject uses estrogen-containing hormonal contraception or hormone replacement therapy.

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 12 mg of nicotine; no flavor; nicotine powder particle size of 2.25 ± 0.2 μm	Other	Product Sequence 1, Product Sequence 2, Product Sequence 3, Product Sequence 4, Product Sequence 5, Product Sequence 6
P3P 22 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm	Other	Product Sequence 1, Product Sequence 2, Product Sequence 3, Product Sequence 4, Product Sequence 5, Product Sequence 6
P3P 31 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm	Other	Product Sequence 1, Product Sequence 2, Product Sequence 3, Product Sequence 4, Product Sequence 5, Product Sequence 6
P3P 42 mg of nicotine; flavor; nicotine powder particle size of 1.8 ± 0.2 μm	Other	Product Sequence 1, Product Sequence 2, Product Sequence 3, Product Sequence 4, Product Sequence 5, Product Sequence 6

Primary outcome

Plasma Nicotine Concentration-time Profile
Time frame: Derived from multiple blood sampling (measured at 2 mins, 4 mins, 7 mins, 10 mins, 15 mins, 30 mins, 1 hour, 2 hours, and 4 hours post-product use) on Days 1, 2, 3 and 4
To measure the plasma nicotine concentration-time profile of four P3P variants from the fixed puffing regimen, following correction of baseline nicotine levels.
Maximum Plasma Concentration [Cmax]
Time frame: Derived from multiple blood sampling (measured at 2 mins, 4 mins, 7 mins, 10 mins, 15 mins, 30 mins, 1 hour, 2 hours, and 4 hours post-product use) on Days 1, 2, 3 and 4
To measure the maximum nicotine plasma concentration [Cmax] of four P3P variants from the fixed puffing regimen, following correction of baseline nicotine levels.
Time to the Maximum Nicotine Concentration [Tmax]
Time frame: Derived from multiple blood sampling (measured at 2 mins, 4 mins, 7 mins, 10 mins, 15 mins, 30 mins, 1 hour, 2 hours, and 4 hours post-product use) on Days 1, 2, 3 and 4
To measure the time to maximum nicotine concentration [Tmax] of four P3P variants from the fixed puffing regimen, following correction of baseline nicotine levels.
Area Under the Concentration-time Curve From Start of Product Use (T0 Fix) to 4 Hours [AUCfix (0-4h)]
Time frame: Derived from multiple blood sampling (measured at 2 mins, 4 mins, 7 mins, 10 mins, 15 mins, 30 mins, 1 hour, 2 hours, and 4 hours post-product use) on Days 1, 2, 3 and 4
To measure the area under the plasma concentration-time curve of four P3P variants from the fixed puffing regimen, following correction of baseline nicotine levels.

14 secondary outcomes

Plasma Nicotine Concentration-time Profile
Time frame: Derived from multiple blood sampling (measured at 10 mins, 20 mins, 30 mins, 40 mins, 1 hour, 2 hours, and 4 hours during and post-ad libitum use) on Days 1, 2, 3 and 4
Peak Plasma Nicotine Concentration [Cpeak]
Time frame: Derived from multiple blood sampling (measured at 10 mins, 20 mins, 30 mins, 40 mins, 1 hour, 2 hours, and 4 hours during and post-ad libitum use) on Days 1, 2, 3 and 4
Time to Peak Plasma Nicotine Concentration [Tpeak]
Time frame: Derived from multiple blood sampling (measured at 10 mins, 20 mins, 30 mins, 40 mins, 1 hour, 2 hours, and 4 hours during and post-ad libitum use) on Days 1, 2, 3 and 4
Trough Plasma Nicotine Concentration [Ctrough]
Time frame: Derived from multiple blood sampling (measured at 10 mins, 20 mins, 30 mins, 40 mins, 1 hour, 2 hours, and 4 hours during and post-ad libitum use) on Days 1, 2, 3 and 4
Average of Plasma Nicotine Concentration From T0 ad Lib to 1 Hour [Caverage]
Time frame: Derived from multiple blood sampling (measured at 10 mins, 20 mins, 30 mins, 40 mins, 1 hour during ad libitum use) on Days 1, 2, 3 and 4
Area Under the Concentration-time Curve From Start of Product Use (T0 ad Lib) to 4 Hours [AUCad Lib (0-4h)]
Time frame: Derived from multiple blood sampling (measured at 10 mins, 20 mins, 30 mins, 40 mins, 1 hour, 2 hours, and 4 hours during and post-ad libitum use) on Days 1, 2, 3 and 4
AUC of Craving for a Cigarette During and After the Fixed Puffing Regimen
Time frame: During and up to 4 hours post-product use on days 1, 2, 3 and 4
AUC Craving for a Cigarette During and After the ad Libitum Use Period
Time frame: During and up to 4 hours post-product use on days 1, 2, 3 and 4
Product Evaluation
Time frame: Within 60 minutes after the ad libitum use session on days 1, 2, 3 and 4
Sensory Parameters
Time frame: Within 60 minutes after the ad libitum use session on days 1, 2, 3 and 4
Human Puffing Topography (HPT) Parameters (Puff Volume) of Four P3P Variants During the Fixed Puffing Regimen Period.
Time frame: During fixed puffing product use on days 1, 2, 3 and 4
Human Puffing Topography (HPT) Parameters (Puff Volume) of Four P3P Variants During the ad Libitum Use Period.
Time frame: During ad libitum product use on days 1, 2, 3 and 4
Amount of Powder Aerosolized From P3P From the Fixed Puffing Regimen.
Time frame: Before and after fixed puffing product use on days 1, 2, 3 and 4
Amount of Powder Aerosolized From P3P From the ad Libitum Use Period (Per Product Used).
Time frame: Before and after ad libitum product use on days 1, 2, 3 and 4

Results and safety

Results posted to the registry on 31 Jan 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
Product Sequence 1	3	3
Product Sequence 2	3	3
Product Sequence 3	3	3
Product Sequence 4	3	3
Product Sequence 5	3	3
Product Sequence 6	3	3

Primary outcome: Plasma Nicotine Concentration-time Profile

Time frame: Derived from multiple blood sampling (measured at 2 mins, 4 mins, 7 mins, 10 mins, 15 mins, 30 mins, 1 hour, 2 hours, and 4 hours post-product use) on Days 1, 2, 3 and 4. Geometric mean (95% Confidence Interval). Unit: ng/mL

Measure	P3P 1 n = 16	P3P 2 n = 16	P3P 3 n = 16	P3P 4 n = 16
2 mins after start of fixed puffing product use	0.751 (0.447 to 1.26)	0.336 (0.200 to 0.562)	0.205 (0.119 to 0.351)	0.478 (0.278 to 0.824)
4 mins after start of fixed puffing product use	1.56 (1.05 to 2.32)	0.740 (0.489 to 1.12)	0.394 (0.206 to 0.756)	1.20 (0.762 to 1.89)
7 mins after start of fixed puffing product use	2.01 (1.44 to 2.79)	1.20 (0.910 to 1.58)	0.547 (0.330 to 0.906)	1.66 (1.18 to 2.33)
10 mins after start of fixed puffing product use	2.33 (1.75 to 3.11)	1.54 (1.23 to 1.93)	0.701 (0.411 to 1.19)	1.92 (1.43 to 2.57)
15 mins after start of fixed puffing product use	2.62 (1.92 to 3.56)	1.78 (1.35 to 2.35)	0.947 (0.661 to 1.36)	2.31 (1.87 to 2.85)
30 mins after start of fixed puffing product use	2.40 (1.97 to 2.91)	1.98 (1.57 to 2.51)	0.931 (0.697 to 1.24)	2.25 (1.91 to 2.64)
1 hour after start of fixed puffing product use	1.97 (1.60 to 2.42)	1.71 (1.35 to 2.18)	0.758 (0.573 to 1.00)	1.85 (1.57 to 2.19)
2 hours after start of fixed puffing product use	1.20 (0.911 to 1.57)	1.17 (0.897 to 1.53)	0.383 (0.241 to 0.607)	1.23 (1.00 to 1.51)

Population analysed: Baseline correction of nicotine concentrations could be performed for 16 out of the 18 randomized subjects.

Primary outcome: Maximum Plasma Concentration [Cmax]

Measure	P3P 1 n = 16	P3P 2 n = 16	P3P 3 n = 16	P3P 4 n = 16
Value	3.08 (2.33 to 4.06)	2.13 (1.62 to 2.81)	1.14 (0.768 to 1.68)	2.79 (2.10 to 3.71)

Population analysed: Baseline correction of nicotine concentrations could be performed for 16 out of the 18 randomized subjects

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

Time frame: Derived from multiple blood sampling (measured at 2 mins, 4 mins, 7 mins, 10 mins, 15 mins, 30 mins, 1 hour, 2 hours, and 4 hours post-product use) on Days 1, 2, 3 and 4. Median (Full Range). Unit: minutes

Measure	P3P 1 n = 16	P3P 2 n = 16	P3P 3 n = 16	P3P 4 n = 16
Value	15.0 (4.00 to 60.0)	22.5 (4.00 to 62.0)	15.0 (4.00 to 60.0)	15.0 (4.00 to 70.0)

Population analysed: Baseline correction of nicotine concentrations could be performed for 16 out of the 18 randomized subjects.

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

Measure	P3P 1 n = 16	P3P 2 n = 16	P3P 3 n = 16	P3P 4 n = 16
Value	5.84 (4.56 to 7.48)	5.08 (3.97 to 6.50)	2.37 (1.67 to 3.37)	5.73 (4.45 to 7.39)

Population analysed: Baseline correction of nicotine concentrations could be performed for 16 out of the 18 randomized subjects.

14 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 duration of up to 34 days for each subject.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Safety Population (P3P 1)	0 of 18 (0%)	4 of 18 (22.2%)	0 of 18
Safety Population (P3P 2)	0 of 18 (0%)	5 of 18 (27.8%)	0 of 18
Safety Population (P3P 3)	0 of 19 (0%)	4 of 19 (21.1%)	0 of 19
Safety Population (P3P 4)	0 of 18 (0%)	3 of 18 (16.7%)	0 of 18

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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 S.A.

Milko Radicioni, MD principal investigator

CROSS Research, Arzo, Ticino, Switzerland

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 1, P3P 2 and P3P 3 in people with Pharmacokinetics, run by Philip Morris Products S.A. at 1 site in Switzerland.

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 7 inclusion and 2 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 31 Jan 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 Switzerland. 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 31 Jan 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 (measured at 2 mins, 4 mins, 7 mins, 10 mins, 15 mins, 30 mins, 1 hour, 2 hours, and 4 hours post-product use) on Days 1, 2, 3 and 4). 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 NCT03369340.

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 31 Jan 2020.