Trial Outcomes & Findings for Nicotine Pharmacokinetics Following Use of the P4M3 Gen 2.0 E-Cigarette Compared to Smoking Cigarettes (NCT NCT05383508)
NCT ID: NCT05383508
Last Updated: 2024-04-26
Results Overview
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.
COMPLETED
NA
36 participants
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.)
2024-04-26
Participant Flow
36 subjects were enrolled in the study, which was conducted at a clinical trial facility managed by a contract research organization.
The 36 enrolled subjects were each randomized to one of six possible use sequences of product use.
Participant milestones
| Measure |
Product Sequence 1
Subjects randomized to this product use sequence:
CA35 on Day 1; Cig on Day 2; CM35 on Day 3
|
Product Sequence 2
Subjects randomized to this product use sequence:
CA35 on Day 1; CM35 on Day 2; Cig on Day 3
|
Product Sequence 3
Subjects randomized to this product use sequence:
Cig on Day 1; CA35 on Day 2; CM35 on Day 3
|
Product Sequence 4
Subjects randomized to this product use sequence:
Cig on Day 1; CM35 on Day 2; CA35 on Day 3
|
Product Sequence 5
Subjects randomized to this product use sequence:
CM35 on Day 1; Cig on Day 2; CA35 on Day 3
|
Product Sequence 6
Subjects randomized to this product use sequence:
CM35 on Day 1; CA35 on Day 2; Cig on Day 3
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
5
|
6
|
5
|
5
|
4
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
1
|
1
|
2
|
0
|
Reasons for withdrawal
| Measure |
Product Sequence 1
Subjects randomized to this product use sequence:
CA35 on Day 1; Cig on Day 2; CM35 on Day 3
|
Product Sequence 2
Subjects randomized to this product use sequence:
CA35 on Day 1; CM35 on Day 2; Cig on Day 3
|
Product Sequence 3
Subjects randomized to this product use sequence:
Cig on Day 1; CA35 on Day 2; CM35 on Day 3
|
Product Sequence 4
Subjects randomized to this product use sequence:
Cig on Day 1; CM35 on Day 2; CA35 on Day 3
|
Product Sequence 5
Subjects randomized to this product use sequence:
CM35 on Day 1; Cig on Day 2; CA35 on Day 3
|
Product Sequence 6
Subjects randomized to this product use sequence:
CM35 on Day 1; CA35 on Day 2; Cig on Day 3
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
1
|
2
|
0
|
Baseline Characteristics
Nicotine Pharmacokinetics Following Use of the P4M3 Gen 2.0 E-Cigarette Compared to Smoking Cigarettes
Baseline characteristics by cohort
| Measure |
Safety Population
n=35 Participants
Safety Population = All subjects who were exposed to the investigational product
|
|---|---|
|
Age, Continuous
|
43.6 years
STANDARD_DEVIATION 11.10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
25 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
BMI
|
29.783 kg/m²
STANDARD_DEVIATION 3.534 • n=5 Participants
|
PRIMARY outcome
Timeframe: 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.)Population: The analysis population was a subset of the Safety Population and consisted of all randomized subjects, without major protocol deviations, for whom at least one nicotine PK parameter could be derived.
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.
Outcome measures
| Measure |
CA35
n=22 Participants
P4M3 Gen 2.0 Classic Auburn 3.5% nicotine
|
CM35
n=23 Participants
P4M3 Gen 2.0 Classic Menthol 3.5% nicotine
|
Cigarettes
n=23 Participants
Subject's own cigarettes
|
|---|---|---|---|
|
Background-corrected Maximum Plasma Concentration [Cmax]
|
2.934 (ng/mL)
Interval 1.695 to 5.08
|
3.365 (ng/mL)
Interval 1.919 to 5.9
|
17.49 (ng/mL)
Interval 12.29 to 24.89
|
PRIMARY outcome
Timeframe: 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.)Population: The analysis population was a subset of the Safety Population and consisted of all randomized subjects, without major protocol deviations, for whom at least one nicotine PK parameter could be derived.
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.
Outcome measures
| Measure |
CA35
n=22 Participants
P4M3 Gen 2.0 Classic Auburn 3.5% nicotine
|
CM35
n=23 Participants
P4M3 Gen 2.0 Classic Menthol 3.5% nicotine
|
Cigarettes
n=23 Participants
Subject's own cigarettes
|
|---|---|---|---|
|
Background-corrected Time to the Maximum Concentration [Tmax]
|
109.3 minutes
Interval -33.28 to 251.8
|
37.79 minutes
Interval -15.62 to 91.21
|
7.826 minutes
Interval 6.926 to 8.726
|
PRIMARY outcome
Timeframe: 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.)Population: The analysis population was a subset of the Safety Population and consisted of all randomized subjects, without major protocol deviations, for whom at least one nicotine PK parameter could be derived.
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.
Outcome measures
| Measure |
CA35
n=14 Participants
P4M3 Gen 2.0 Classic Auburn 3.5% nicotine
|
CM35
n=14 Participants
P4M3 Gen 2.0 Classic Menthol 3.5% nicotine
|
Cigarettes
n=19 Participants
Subject's own cigarettes
|
|---|---|---|---|
|
Area Under the Background-corrected Concentration-time Curve From Start of Product Use to Time of Last Quantifiable Concentration and Extrapolated to Infinity.
|
891.1 min*ng/mL
Interval 515.6 to 1540.0
|
655.6 min*ng/mL
Interval 317.0 to 1356.0
|
2484 min*ng/mL
Interval 1880.0 to 3283.0
|
PRIMARY outcome
Timeframe: 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.)Population: The analysis population was a subset of the Safety Population and consisted of all randomized subjects, without major protocol deviations, for whom at least one nicotine PK parameter could be derived.
To measure the maximum ratio of background-corrected concentration over time, from T0 (excluded) to Tmax (included)
Outcome measures
| Measure |
CA35
n=22 Participants
P4M3 Gen 2.0 Classic Auburn 3.5% nicotine
|
CM35
n=23 Participants
P4M3 Gen 2.0 Classic Menthol 3.5% nicotine
|
Cigarettes
n=23 Participants
Subject's own cigarettes
|
|---|---|---|---|
|
Maximum Ratio of Background-corrected Concentration Over Time
|
0.3547 (ng/mL)/min
Interval 0.1618 to 0.7777
|
0.5150 (ng/mL)/min
Interval 0.276 to 0.961
|
3.239 (ng/mL)/min
Interval 2.277 to 4.608
|
Adverse Events
Safety Population (CA35 Test)
Safety Population (CA35)
Safety Population (CM35)
Cigarettes
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Christelle Haziza, Global Head Clinical Research and Execution
Philip Morris Products S.A.
Results disclosure agreements
- Principal investigator is a sponsor employee We confirm we have the contractual provisions in place which specify that in no event will the study site be allowed to disclose to any third party (or publicly release) any information obtained through the study without the CRO's prior written consent which in turn cannot provide such consent without Sponsor's approval unless such publication is made to satisfy regulatory requirements. The Intellectual Property rights and research results from the present study belong to the Sponsor.
- Publication restrictions are in place
Restriction type: OTHER