An interventional study of CA35 and CM35 in Nicotine Vaping, Nicotine and Vaping, sponsored by Philip Morris Products S.A.. Completed at 1 site in United States. Open to participants aged 24 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-26.
Sponsored by Philip Morris Products S.A. · Not applicable, Interventional, and Other
This is a single-center, randomized, controlled, open-label, cross-over study with healthy adult smokers. The study will investigate the nicotine pharmacokinetic (PK) profiles of two e-liquid variants used with the P4M3 Gen 2.0 e-cigarette, compared to smoking combustible cigarettes.
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.
The purpose of the study is to evaluate the nicotine pharmacokinetics (PK) profiles of two e-liquid variants used with the P4M3 Gen 2.0 e-cigarette versus cigarettes following a six minutes ad libitum use period. In addition, pharmacodynamic effects (PD), including subjective effects and related behavioral assessments, as well as human puffing topography (HPT) will be evaluated, to provide further insights on P4M3 Gen 2.0 product acceptance and product use. Safety will be assessed throughout the study.
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.
Philip Morris Products S.A. is the lead sponsor of 46 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Other: CA35 · Other: CM35 · Other: Cig
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
Other: CA35 · Other: CM35 · Other: Cig
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
Other: CA35 · Other: CM35 · Other: Cig
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
Other: CA35 · Other: CM35 · Other: Cig
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
Other: CA35 · Other: CM35 · Other: Cig
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
Other: CA35 · Other: CM35 · Other: Cig
Nicotine concentration: 3.5 % e-liquid flavor: Tobacco
Also known as: P4M3 variant CA35
Nicotine concentration: 3.5 % e-liquid flavor: Menthol
Also known as: P4M3 variant CM35
Subjects' preferred brand of commercially available, regular or mentholated cigarettes
Background-corrected Maximum Plasma Concentration [Cmax]
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.
Time frame: 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.)
Background-corrected Time to the Maximum Concentration [Tmax]
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.
Time frame: 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.)
Area Under the Background-corrected Concentration-time Curve From Start of Product Use to Time of Last Quantifiable Concentration and Extrapolated to Infinity.
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.
Time frame: 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.)
Maximum Ratio of Background-corrected Concentration Over Time
To measure the maximum ratio of background-corrected concentration over time, from T0 (excluded) to Tmax (included)
Time frame: 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.)
36 subjects were enrolled in the study, which was conducted at a clinical trial facility managed by a contract research organization.
| Milestone | Product Sequence 1 | Product Sequence 2 | Product Sequence 3 | Product Sequence 4 | Product Sequence 5 | Product Sequence 6 |
|---|---|---|---|---|---|---|
| Started | 6 | 6 | 6 | 6 | 6 | 6 |
| Completed | 5 | 6 | 5 | 5 | 4 | 6 |
| Not completed | 1 | 0 | 1 | 1 | 2 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 | 1 | 1 | 2 | 0 |
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.
| (ng/mL) | CA35 | CM35 | Cigarettes |
|---|---|---|---|
| Background-corrected Maximum Plasma Concentration [Cmax] | 2.934 (1.695 to 5.080) | 3.365 (1.919 to 5.900) | 17.49 (12.29 to 24.89) |
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.
| minutes | CA35 | CM35 | Cigarettes |
|---|---|---|---|
| Background-corrected Time to the Maximum Concentration [Tmax] | 109.3 (-33.28 to 251.8) | 37.79 (-15.62 to 91.21) | 7.826 (6.926 to 8.726) |
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.
| min*ng/mL | CA35 | CM35 | 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 (515.6 to 1540) | 655.6 (317.0 to 1356) | 2484 (1880 to 3283) |
To measure the maximum ratio of background-corrected concentration over time, from T0 (excluded) to Tmax (included)
| (ng/mL)/min | CA35 | CM35 | Cigarettes |
|---|---|---|---|
| Maximum Ratio of Background-corrected Concentration Over Time | 0.3547 (0.1618 to 0.7777) | 0.5150 (0.2760 to 0.9610) | 3.239 (2.277 to 4.608) |
Collected over Adverse events were collected from the signature of the ICF by each subject until the end of the safety follow-up period, a total duration for each subject of up to 34 days.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Safety Population (CA35 Test) | 0/35 (0%) | 0/35 (0%) | 0/35 (0%) |
| Safety Population (CA35) | 0/32 (0%) | 0/32 (0%) | 0/32 (0%) |
| Safety Population (CM35) | 0/33 (0%) | 0/33 (0%) | 0/33 (0%) |
| Cigarettes | 0/34 (0%) | 0/34 (0%) | 0/34 (0%) |
| Age, Continuous(years) | Safety Population |
|---|---|
| Mean | 43.6 ± 11.10 |
| Sex: Female, Male(Participants) | Safety Population |
|---|---|
| Female | 14 |
| Male | 21 |
| Race/Ethnicity, Customized(Participants) | Safety Population |
|---|---|
| Black or African American | 25 |
| White | 10 |
| Not Hispanic or Latino | 0 |
| BMI(kg/m²) | Safety Population |
|---|---|
| Mean | 29.783 ± 3.534 |
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Philip Morris Products S.A.