Trial Outcomes & Findings for Nicotine Pharmacokinetics of THS Single Use of a Regular or a Menthol Stick Compared to CIG (NCT NCT05789420)
NCT ID: NCT05789420
Last Updated: 2024-11-22
Results Overview
To measure Cmax from the single use of THS with either a regular or a menthol stick or of a single cigarette.
COMPLETED
NA
31 participants
Measured from start of product use to 24 hours
2024-11-22
Participant Flow
32 subjects were screened for the study who gave informed consent and had at least one safety assessment, which were the criteria for inclusion in the Safety Population. 31 subjects were enrolled (one subject completed alternate status but was not needed for study participation due to closed enrollment). One of the enrolled subjects was discontinued due to positive alcohol breath and urine tests on Day -1. A total of 30 subjects were randomized to participate in the study.
Participant milestones
| Measure |
Safety Population
The safety population consisted of all subjects (screened \[32\], enrolled \[31\], and randomized \[30\]) who gave informed consent and had at least one safety assessment.
|
|---|---|
|
Screening and Safety Assessments
STARTED
|
32
|
|
Screening and Safety Assessments
COMPLETED
|
31
|
|
Screening and Safety Assessments
NOT COMPLETED
|
1
|
|
Enrollment
STARTED
|
31
|
|
Enrollment
COMPLETED
|
31
|
|
Enrollment
NOT COMPLETED
|
0
|
|
Randomization to Product Assessments
STARTED
|
31
|
|
Randomization to Product Assessments
P1R Stick
|
30
|
|
Randomization to Product Assessments
P1M Stick
|
30
|
|
Randomization to Product Assessments
CIG
|
30
|
|
Randomization to Product Assessments
COMPLETED
|
30
|
|
Randomization to Product Assessments
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Safety Population
The safety population consisted of all subjects (screened \[32\], enrolled \[31\], and randomized \[30\]) who gave informed consent and had at least one safety assessment.
|
|---|---|
|
Screening and Safety Assessments
Completed Alternate Status
|
1
|
|
Randomization to Product Assessments
Failed alcohol breath test and urine test on day -1
|
1
|
Baseline Characteristics
Nicotine Pharmacokinetics of THS Single Use of a Regular or a Menthol Stick Compared to CIG
Baseline characteristics by cohort
| Measure |
Safety Population
n=32 Participants
The safety population consisted of all subjects (screened \[32\], enrolled \[31\], and randomized \[30\]) who gave informed consent and had at least one safety assessment.
|
|---|---|
|
Age, Continuous
|
39.6 years
STANDARD_DEVIATION 10.40 • n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
32 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
32 Participants
n=5 Participants
|
|
Body Mass Index
|
26.037 kg/m²
STANDARD_DEVIATION 2.8629 • n=5 Participants
|
PRIMARY outcome
Timeframe: Measured from start of product use to 24 hoursPopulation: Some participants were excluded from analysis for protocol deviations (including, but not limited to, missing measurements).
To measure Cmax from the single use of THS with either a regular or a menthol stick or of a single cigarette.
Outcome measures
| Measure |
P1R (THS Regular Stick)
n=30 Participants
Randomized subjects exposed to P1R (THS Regular Stick).
|
P1M (THS Menthol Stick)
n=30 Participants
Randomized subjects exposed to P1M (THS Menthol stick).
|
CIG (Cigarette)
n=30 Participants
Randomized subjects using their own Cigarettes (CIG).
|
|---|---|---|---|
|
Maximum Plasma Concentration [Cmax]
|
8.425 ng/mL
Interval 6.582 to 10.78
|
7.475 ng/mL
Interval 5.464 to 10.23
|
13.43 ng/mL
Interval 10.29 to 17.53
|
PRIMARY outcome
Timeframe: Measured from start of product use to 24 hoursTo measure Tmax from the single use of THS with either a regular or a menthol stick or of a single cigarette.
Outcome measures
| Measure |
P1R (THS Regular Stick)
n=30 Participants
Randomized subjects exposed to P1R (THS Regular Stick).
|
P1M (THS Menthol Stick)
n=30 Participants
Randomized subjects exposed to P1M (THS Menthol stick).
|
CIG (Cigarette)
n=30 Participants
Randomized subjects using their own Cigarettes (CIG).
|
|---|---|---|---|
|
Time to the Maximum Concentration [Tmax]
|
6.025 minutes
Interval 3.73 to 32.3
|
5.942 minutes
Interval 3.87 to 60.0
|
7.725 minutes
Interval 5.93 to 30.0
|
PRIMARY outcome
Timeframe: Measured from start of product use to 24 hoursTo measure AUC0-24h from the single use of THS with either a regular or a menthol stick or of a single cigarette.
Outcome measures
| Measure |
P1R (THS Regular Stick)
n=30 Participants
Randomized subjects exposed to P1R (THS Regular Stick).
|
P1M (THS Menthol Stick)
n=30 Participants
Randomized subjects exposed to P1M (THS Menthol stick).
|
CIG (Cigarette)
n=30 Participants
Randomized subjects using their own Cigarettes (CIG).
|
|---|---|---|---|
|
Area Under the Curve of Nicotine Plasma Concentration-time Computed From T0 to T=24 Hours [AUC0-24h]
|
879.4 ng*min/mL
Interval 682.1 to 1134.0
|
715.5 ng*min/mL
Interval 510.0 to 1004.0
|
1436 ng*min/mL
Interval 1085.0 to 1901.0
|
PRIMARY outcome
Timeframe: Measured from start of product use to 24 hoursTo measure the area under the curve of nicotine plasma concentration-time computed from T0 to the subject-specific time of maximum nicotine concentration \[AUC0-t'\], from the single use of THS with either a regular or a menthol stick or from a single cigarette. (AUC0-Tmax)
Outcome measures
| Measure |
P1R (THS Regular Stick)
n=30 Participants
Randomized subjects exposed to P1R (THS Regular Stick).
|
P1M (THS Menthol Stick)
n=30 Participants
Randomized subjects exposed to P1M (THS Menthol stick).
|
CIG (Cigarette)
n=30 Participants
Randomized subjects using their own Cigarettes (CIG).
|
|---|---|---|---|
|
Area Under the Curve of Nicotine Plasma Concentration-time Computed From T0 to the Subject-specific Time of Maximum Nicotine Concentration [AUC0-t']
|
40.16 ng*min/mL)
Interval 32.02 to 50.36
|
29.22 ng*min/mL)
Interval 22.08 to 38.66
|
58.23 ng*min/mL)
Interval 47.13 to 71.95
|
Adverse Events
Safety Population
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Xavier Jaumont, Global Head of Clinical Development and Operations
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