VapingNCT03379740

Study to Investigate the Nicotine Pharmacokinetic Profiles and Pharmacodynamic Effects of P4M3 Variants

A study testing E-cigarette, P4M3-1.7% and P4M3-1.7%LA in people with Vaping and Nicotine Absorption, run by Philip Morris Products S.A. at 1 site in United States.

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

This is a single-center, open-label, concentration-ranging study to evaluate the nicotine PK profile and PD effects in healthy adult experienced users of closed tank/cartridge e-cigarettes using four different variants of P4M3 (nicotine concentration of 1.7%, 1.7% with 1.1% lactic acid [LA], 3% with 1.1% LA, and 4%… Read more about this study

Who is it for?: Ages 21 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Vaping, Nicotine Absorption
What is being tested?: E-cigarette, P4M3-1.7% and P4M3-1.7%LA
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteUnited States
Study dates: 11 Jul 2017to 1 Dec 2017
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 21 to 65 years of age, inclusive, at the Screening Visit.
Subject is a former daily cigarette smoker who smoked at least 100 cigarettes or more in his/her life and ceased smoking at least 3 months prior to the Screening Visit.
Subject has been using a commercially available, nicotine-containing closed tank/cartridge e-cigarette daily for at least 3 months prior to the Screening Visit.
Subject has a urine cotinine test ≥200 ng/mL at the Screening Visit and Admission.

Who cannot join

Subject has a clinically relevant disease which requires medication which as per the judgment of the Investigator would jeopardize the safety of the subject.
Subject has abnormal renal function test result or subject with a creatinine clearance <60 mL/minute at the Screening Visit, confirmed on repeat testing.
Subject has elevated liver function test results at the Screening Visit.
Subject has bilirubin >1.5X ULN at the Screening Visit.
Subject has FEV1/FVC <0.7 and FEV1 <80% predicted value at post-bronchodilator spirometry at the Screening Visit.
Subject has asthma condition at the Screening Visit.

Show all 15Show fewer

Subject has received medication within 14 days or within 5 half-lives of the drug (whichever is longer) prior to Admission, which has an impact on cytochrome P450 (CYP) 2A6 activity.
Subject has a carbon monoxide (CO) breath test ≥ 10 ppm at the Screening Visit or Admission.
Subject has a body mass index (BMI) <18.5 kg/m2 or BMI ≥35 kg/m2 at the Screening Visit.
Subject has a positive serology test for human immunodeficiency virus (HIV) 1/2, hepatitis B, or hepatitis C at the Screening Visit.
Subject has clinically significant ECG findings at the Screening Visit.
Subject has participated in a clinical study within 3 months prior to the Screening Visit.
Subject smokes cigarettes or uses other tobacco products.
Female subject of childbearing potential who is pregnant or breastfeeding.
Female subject of childbearing potential who does not agree to use an acceptable method of effective contraception..

Trial locations and contacts

1 site in 1 country.

United States1 site

High Point Clinical Trials Center
High Point, North Carolina, 27265

Other trials in United States

About this study

Official title: A Single-center, Open-label, Concentration-ranging Study to Investigate the Nicotine Pharmacokinetic Profiles and Pharmacodynamic Effects of the P4M3 Variants

Read the detailed description

The goal of the study is to evaluate the nicotine concentration profiles and derived PK parameters, subjective effects, behavioral parameters, including puffing topography parameters of P4M3 with four different variants of P4M3, in experienced e-cigarette users after a single-use experience with fixed puffing regime and after ad libitum use of P4M3.

Four variants of P4M3 will be evaluated together with subjects' own e-cigarettes to evaluate the relationship between the e-liquid composition (nicotine concentrations and presence of lactic acid) and the amount of nicotine absorbed, the speed of absorption, and the puffing topography.

Conditions: Vaping, Nicotine Absorption
Being tested: E-cigarette, P4M3-1.7%, P4M3-1.7%LA, P4M3-3%LA, P4M3-4%LA
Keywords: Nicotine-containing product, Alternative to cigarettes
Medical subject headings: Vaping

What participants receive

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

E-cigaretteOther
Subject's own e-cigarette
P4M3-1.7%Other
P4M3 e-liquid concentration of 1.7% nicotine without lactic acid
P4M3-1.7%LAOther
P4M3 e-liquid concentration of 1.7% nicotine with lactic acid
P4M3-3%LAOther
P4M3 e-liquid concentration of 3% nicotine with lactic acid
P4M3-4%LAOther
P4M3 e-liquid concentration of 4% nicotine with lactic acid

Study groups in NCT03379740
Study group	Role	What they receive
Product Exposure Sequence 1	Experimental	Subjects will be randomized to follow a sequence of product exposure comprised of : Subject's own e-cigarette; P4M3-1.7%; P4M3-1.7%LA; P4M3-3%LA; and P4M3-4%LA Receives: Other: E-cigarette; Other: P4M3-1.7%; Other: P4M3-1.7%LA; Other: P4M3-3%LA; Other: P4M3-4%LA
Product Exposure Sequence 2	Experimental	Subjects will be randomized to follow a sequence of product exposure comprised of : Subject's own e-cigarette; P4M3-1.7%LA; P4M3-1.7%; P4M3-3%LA; and P4M3-4%LA Receives: Other: E-cigarette; Other: P4M3-1.7%; Other: P4M3-1.7%LA; Other: P4M3-3%LA; Other: P4M3-4%LA

What is being measured

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

Plasma Nicotine Concentration Versus Time Profile
To measure total and background-corrected plasma nicotine concentration versus time profiles from 60 minutes of ad libitum use.
Measured: From Day -1 (baseline) to Day 4
Peak Plasma Nicotine Concentration [cCpeak]
To measure background-corrected peak plasma nicotine concentration [cCpeak] from 60 minutes of ad libitum use.
Measured: From Day -1 (baseline) to Day 4
Time to Peak Plasma Nicotine Concentration [Tpeak]
To measure the time to peak plasma nicotine concentration [tpeak] from 60 minutes of ad libitum use.
Measured: From Day -1 (baseline) to Day 4
Background-corrected Trough Plasma Nicotine Concentration [cCtrough]
To measure background-corrected trough plasma nicotine concentration [cCtrough] from 60 minutes of ad libitum use.
Measured: From Day -1 (baseline) to Day 4
Background-corrected Average of Plasma Nicotine Concentration [cCaverage]
To measure background-corrected average of plasma nicotine concentration between 0 to 1 hour [cCaverage] from 60 minutes of ad libitum use.
Measured: From Day -1 (baseline) to Day 4

Secondary outcomes (9)

Total and Background-corrected Plasma Nicotine Concentration Versus Time Profiles
To measure the total and background-corrected plasma nicotine concentration versus time profiles of the P4M3 variants and subjects' own e-cigarette from the fixed puffing regimen.
Measured: From Day -1 (baseline) to Day 4
Background-corrected Maximum Plasma Concentration [cCmax]
To measure the background-corrected maximum plasma concentration [cCmax] of the P4M3 variants and subjects' own e-cigarette from the fixed puffing regimen.
Measured: From Day -1 (baseline) to Day 4
Time to the Maximum Concentration [Tmax]
To measure the time to the maximum concentration [tmax] of the P4M3 variants and subjects' own e-cigarette from the fixed puffing regimen.
Measured: From Day -1 (baseline) to Day 4
Background-corrected Area Under the Concentration-time Curve [cAUC(0-4h)]
To measure the background-corrected area under the concentration-time curve, which is above the corrected baseline from the start of product use to 4 hours [cAUC(0-4h)], of the P4M3 variants and subjects' own e-cigarette from the fixed puffing regimen.
Measured: From Day -1 (baseline) to Day 4
Subjective Effects of P4M3 Use
Measured with an adapted version of the modified Cigarette Evaluation Questionnaire (adapted mCEQ) within 60 minutes after the ad libitum use session. Assessed on a 7-point scale, ranging from 1 (not at all) to 7 (extremely).
Measured: From Day -1 (baseline) to Day 4
Area Under the Curve of Craving for an Electronic Cigarette
Measured on a Visual Analogue Scale (VAS) of 0 (no craving) to 100 (strong craving), before and after the fixed puffing regimen and ad libitum use period. (The VAS craving was measured from 0 to 100 on a 100 mm scale.)
The data below present the Area under the VAS craving score-time curve from the start of product use to 4 hours.
The area under the curve for VAS craving is an integrated measurement of the VAS craving taking into account several timepoints. AUC was calculated using a trapezoidal rule between timepoints without normalization.
Measured: From Day -1 (baseline) to Day 4
Sensory Parameters (Fixed Puffing Regimen)
Measured with a Sensory Questionnaire (SQ) within 60 minutes after each fixed puffing regimen use period. Response to each question is assessed on a 7-point scale, ranging from 1 (not at all) to 7 (extremely).
Measured: From Day 1 to Day 4
Sensory Parameters (ad Libitum Use)
Measured with a Sensory Questionnaire (SQ) within 60 minutes after each 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: From Day 1 to Day 4
Human Puffing Topography (HPT) of the P4M3 Variants and the Subjects' Own E-cigarette
Total Puff Volume measured for the P4M3 variants and the subjects' own e-cigarette from the fixed puffing regimen and the 60 minutes ad libitum use.
Measured: From Day -1 (baseline) to Day 4

Timeline

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

11 Jul 20171 Dec 2017

First posted20 Dec 2017
Study start11 Jul 2017
Primary completion14 Aug 2017
Study completion1 Dec 2017

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 VapingStudies 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: Parallel groups
Masking: None (open label)
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03379740
Sponsor's protocol ID: P4M3-PK-02-US
Status last verified: Nov 2019
First submitted: 1 Dec 2017
Last updated: 22 Nov 2019
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 22 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-center, Open-label, Concentration-ranging Study to Investigate the Nicotine Pharmacokinetic Profiles and Pharmacodynamic Effects of the P4M3 Variants
ClinicalTrials.gov ID: NCT03379740
Acronym / sponsor ID: P4M3-PK-02-US
Conditions: Vaping, Nicotine Absorption
Keywords: Nicotine-containing product, Alternative to cigarettes
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: Philip Morris Products S.A.Industry (pharma, biotech, devices)
Study start: 11 Jul 2017 (actual)
Primary completion: 14 Aug 2017 (actual)
Study completion: 1 Dec 2017 (actual)
First posted: 20 Dec 2017 (actual)
Results: Posted 22 Nov 2019

Clinical summary

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

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Product Exposure Sequence 1	Experimental	Other: E-cigarette, Other: P4M3-1.7%, Other: P4M3-1.7%LA, Other: P4M3-3%LA, Other: P4M3-4%LASubjects will be randomized to follow a sequence of product exposure comprised of : Subject's own e-cigarette; P4M3-1.7%; P4M3-1.7%LA; P4M3-3%LA; and P4M3-4%LA
Product Exposure Sequence 2	Experimental	Other: E-cigarette, Other: P4M3-1.7%, Other: P4M3-1.7%LA, Other: P4M3-3%LA, Other: P4M3-4%LASubjects will be randomized to follow a sequence of product exposure comprised of : Subject's own e-cigarette; P4M3-1.7%LA; P4M3-1.7%; P4M3-3%LA; and P4M3-4%LA

Who may qualify

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

Key inclusion criteria (5 listed)

Subject has signed the informed consent form (ICF) and is able to understand the information provided in the ICF.
Subject is 21 to 65 years of age, inclusive, at the Screening Visit.
Subject is a former daily cigarette smoker who smoked at least 100 cigarettes or more in his/her life and ceased smoking at least 3 months prior to the Screening Visit.
Subject has been using a commercially available, nicotine-containing closed tank/cartridge e-cigarette daily for at least 3 months prior to the Screening Visit.
Subject has a urine cotinine test ≥200 ng/mL at the Screening Visit and Admission.

Key exclusion criteria (15 listed)

Subject has a clinically relevant disease which requires medication which as per the judgment of the Investigator would jeopardize the safety of the subject.
Subject has abnormal renal function test result or subject with a creatinine clearance <60 mL/minute at the Screening Visit, confirmed on repeat testing.
Subject has elevated liver function test results at the Screening Visit.
Subject has bilirubin >1.5X ULN at the Screening Visit.
Subject has FEV1/FVC <0.7 and FEV1 <80% predicted value at post-bronchodilator spirometry at the Screening Visit.

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
E-cigaretteSubject's own e-cigarette	Other	Product Exposure Sequence 1, Product Exposure Sequence 2
P4M3-1.7%P4M3 e-liquid concentration of 1.7% nicotine without lactic acid	Other	Product Exposure Sequence 1, Product Exposure Sequence 2
P4M3-1.7%LAP4M3 e-liquid concentration of 1.7% nicotine with lactic acid	Other	Product Exposure Sequence 1, Product Exposure Sequence 2
P4M3-3%LAP4M3 e-liquid concentration of 3% nicotine with lactic acid	Other	Product Exposure Sequence 1, Product Exposure Sequence 2
P4M3-4%LAP4M3 e-liquid concentration of 4% nicotine with lactic acid	Other	Product Exposure Sequence 1, Product Exposure Sequence 2

Primary outcome

Plasma Nicotine Concentration Versus Time Profile
Time frame: From Day -1 (baseline) to Day 4
To measure total and background-corrected plasma nicotine concentration versus time profiles from 60 minutes of ad libitum use.
Peak Plasma Nicotine Concentration [cCpeak]
Time frame: From Day -1 (baseline) to Day 4
To measure background-corrected peak plasma nicotine concentration [cCpeak] from 60 minutes of ad libitum use.
Time to Peak Plasma Nicotine Concentration [Tpeak]
Time frame: From Day -1 (baseline) to Day 4
To measure the time to peak plasma nicotine concentration [tpeak] from 60 minutes of ad libitum use.
Background-corrected Trough Plasma Nicotine Concentration [cCtrough]
Time frame: From Day -1 (baseline) to Day 4
To measure background-corrected trough plasma nicotine concentration [cCtrough] from 60 minutes of ad libitum use.
Background-corrected Average of Plasma Nicotine Concentration [cCaverage]
Time frame: From Day -1 (baseline) to Day 4
To measure background-corrected average of plasma nicotine concentration between 0 to 1 hour [cCaverage] from 60 minutes of ad libitum use.

9 secondary outcomes

Total and Background-corrected Plasma Nicotine Concentration Versus Time Profiles
Time frame: From Day -1 (baseline) to Day 4
Background-corrected Maximum Plasma Concentration [cCmax]
Time frame: From Day -1 (baseline) to Day 4
Time to the Maximum Concentration [Tmax]
Time frame: From Day -1 (baseline) to Day 4
Background-corrected Area Under the Concentration-time Curve [cAUC(0-4h)]
Time frame: From Day -1 (baseline) to Day 4
Subjective Effects of P4M3 Use
Time frame: From Day -1 (baseline) to Day 4
Area Under the Curve of Craving for an Electronic Cigarette
Time frame: From Day -1 (baseline) to Day 4
Sensory Parameters (Fixed Puffing Regimen)
Time frame: From Day 1 to Day 4
Sensory Parameters (ad Libitum Use)
Time frame: From Day 1 to Day 4
Human Puffing Topography (HPT) of the P4M3 Variants and the Subjects' Own E-cigarette
Time frame: From Day -1 (baseline) to Day 4

Results and safety

Results posted to the registry on 22 Nov 2019, 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 Exposure Sequence 1	8	8
Product Exposure Sequence 2	7	7

Primary outcome: Plasma Nicotine Concentration Versus Time Profile

Time frame: From Day -1 (baseline) to Day 4. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Subject's Own E-cigarette n = 15	P4M3-1.7% n = 15	P4M3-1.7%LA n = 15	P4M3-3%LA n = 15	P4M3-4%LA n = 15
10 mins	4.546 (99.52)	3.165 (77.27)	4.167 (119.38)	7.518 (93.39)	6.782 (95.57)
20 mins	7.235 (103.89)	5.237 (65.20)	6.990 (121.67)	11.92 (65.52)	9.942 (65.34)
30 mins	8.852 (113.80)	7.808 (62.57)	8.165 (111.02)	17.85 (66.05)	14.65 (60.02)
40 mins	10.25 (111.09)	9.338 (61.00)	9.852 (99.60)	20.72 (63.01)	19.17 (56.21)
60 mins	14.46 (80.78)	13.24 (55.46)	12.64 (96.63)	25.53 (62.65)	25.77 (55.60)
120 mins	8.809 (90.18)	9.356 (69.35)	7.157 (102.04)	15.52 (52.34)	12.76 (50.27)
240 mins	4.297 (91.97)	4.524 (76.68)	3.311 (91.70)	7.490 (53.81)	5.681 (45.33)

Primary outcome: Peak Plasma Nicotine Concentration [cCpeak]

Time frame: From Day -1 (baseline) to Day 4. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Subject's Own E-cigarette n = 15	P4M3-1.7% n = 15	P4M3-1.7%LA n = 15	P4M3-3%LA n = 15	P4M3-4%LA n = 15
Value	14.87 (83.01)	13.32 (55.65)	13.05 (98.16)	26.47 (63.68)	26.57 (57.34)

Primary outcome: Time to Peak Plasma Nicotine Concentration [Tpeak]

Time frame: From Day -1 (baseline) to Day 4. Median (Full Range). Unit: minutes

Measure	Subject's Own E-cigarette n = 15	P4M3-1.7% n = 15	P4M3-1.7%LA n = 15	P4M3-3%LA n = 15	P4M3-4%LA n = 15
Value	60.000 (30.00 to 65.00)	60.000 (60.00 to 122.00)	60.000 (40.00 to 60.00)	60.000 (30.00 to 60.00)	60.000 (40.00 to 65.00)

Primary outcome: Background-corrected Trough Plasma Nicotine Concentration [cCtrough]

Time frame: From Day -1 (baseline) to Day 4. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Subject's Own E-cigarette n = 15	P4M3-1.7% n = 15	P4M3-1.7%LA n = 15	P4M3-3%LA n = 15	P4M3-4%LA n = 15
Value	3.492 (98.26)	2.819 (74.17)	2.905 (101.32)	6.032 (73.40)	4.845 (59.40)

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected over the entire study duration of up to 36 days, with individual subject participation of between 15 to 36 days from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
P4M3-1.7% Product Test	0 of 15 (0%)	1 of 15 (6.7%)	0 of 15
Subject's Own E-cigarette	0 of 15 (0%)	1 of 15 (6.7%)	0 of 15
P4M3-1.7%	0 of 15 (0%)	2 of 15 (13.3%)	0 of 15
P4M3-1.7%LA	0 of 15 (0%)	0 of 15 (0%)	0 of 15
P4M3-3%LA	0 of 15 (0%)	4 of 15 (26.7%)	0 of 15
P4M3-4%LA	0 of 15 (0%)	2 of 15 (13.3%)	0 of 15

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2019.
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.

Jonathan Austin, MD principal investigator

High Point Clinical Trials Center

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

Questions about this trial

What is this clinical trial studying?

A study testing E-cigarette, P4M3-1.7% and P4M3-1.7%LA in people with Vaping and Nicotine Absorption, run by Philip Morris Products S.A. at 1 site in United States.

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 5 inclusion and 15 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 22 Nov 2019. 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 United States. 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 22 Nov 2019). 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 Versus Time Profile (time frame: From Day -1 (baseline) to Day 4). The study lists 5 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 NCT03379740.

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 22 Nov 2019.