Trial Outcomes & Findings for Nicotine Pharmacokinetics and Pharmacodynamics, Safety and Tolerability of P3P (NCT NCT03369340)
NCT ID: NCT03369340
Last Updated: 2020-01-31
Results Overview
To measure the plasma nicotine concentration-time profile of four P3P variants from the fixed puffing regimen, following correction of baseline nicotine levels.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
19 participants
Primary outcome timeframe
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
Results posted on
2020-01-31
Participant Flow
40 subjects were screened for eligibility. 21 subjects were screen failures (10 reserve subjects were not enrolled, 9 subjects did not meet eligibility criteria, and 2 subjects withdrew.)
On Day 1, 19 subjects were enrolled and exposed to "P3P 3" before randomization. One enrolled subject withdrew after P3P 3 use before randomization. 18 subjects were randomized.
Participant milestones
| Measure |
Product Sequence 1
Subjects will 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
Subjects will be 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
Subjects will 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
Subjects will 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
Subjects will 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
Subjects will follow a sequence of product exposure comprised of:
P3P 4 on Day 2; P3P 2 on Day 3; P3P 1 on Day 4
|
|---|---|---|---|---|---|---|
|
Day 2
STARTED
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Day 2
COMPLETED
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Day 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Day 3
STARTED
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Day 3
COMPLETED
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Day 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Day 4
STARTED
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Day 4
COMPLETED
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Day 4
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Nicotine Pharmacokinetics and Pharmacodynamics, Safety and Tolerability of P3P
Baseline characteristics by cohort
| Measure |
Safety Population
n=19 Participants
The safety population comprised all enrolled subjects who were exposed to P3P during the study.
|
|---|---|
|
Age, Continuous
|
35.4 years
STANDARD_DEVIATION 9.03 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Body weight (kg)
|
72.3 kilograms
STANDARD_DEVIATION 12.4 • n=5 Participants
|
|
Height (cm)
|
171 centimetres
STANDARD_DEVIATION 12.6 • n=5 Participants
|
|
BMI (kg/m^2)
|
24.6 kg/m^2
STANDARD_DEVIATION 2.72 • n=5 Participants
|
PRIMARY outcome
Timeframe: 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 4Population: Baseline correction of nicotine concentrations could be performed for 16 out of the 18 randomized subjects.
To measure the plasma nicotine concentration-time profile of four P3P variants from the fixed puffing regimen, following correction of baseline nicotine levels.
Outcome measures
| Measure |
P3P 1
n=16 Participants
2 mg of nicotine; no flavor; nicotine powder particle size of 2.25 ± 0.2 μm
|
P3P 2
n=16 Participants
2 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm
|
P3P 3
n=16 Participants
1 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm
|
P3P 4
n=16 Participants
2 mg of nicotine; flavor; nicotine powder particle size of 1.8 ± 0.2 μm
|
|---|---|---|---|---|
|
Plasma Nicotine Concentration-time Profile
4 mins after start of fixed puffing product use
|
1.56 ng/mL
Interval 1.05 to 2.32
|
0.740 ng/mL
Interval 0.489 to 1.12
|
0.394 ng/mL
Interval 0.206 to 0.756
|
1.20 ng/mL
Interval 0.762 to 1.89
|
|
Plasma Nicotine Concentration-time Profile
2 mins after start of fixed puffing product use
|
0.751 ng/mL
Interval 0.447 to 1.26
|
0.336 ng/mL
Interval 0.2 to 0.562
|
0.205 ng/mL
Interval 0.119 to 0.351
|
0.478 ng/mL
Interval 0.278 to 0.824
|
|
Plasma Nicotine Concentration-time Profile
7 mins after start of fixed puffing product use
|
2.01 ng/mL
Interval 1.44 to 2.79
|
1.20 ng/mL
Interval 0.91 to 1.58
|
0.547 ng/mL
Interval 0.33 to 0.906
|
1.66 ng/mL
Interval 1.18 to 2.33
|
|
Plasma Nicotine Concentration-time Profile
10 mins after start of fixed puffing product use
|
2.33 ng/mL
Interval 1.75 to 3.11
|
1.54 ng/mL
Interval 1.23 to 1.93
|
0.701 ng/mL
Interval 0.411 to 1.19
|
1.92 ng/mL
Interval 1.43 to 2.57
|
|
Plasma Nicotine Concentration-time Profile
15 mins after start of fixed puffing product use
|
2.62 ng/mL
Interval 1.92 to 3.56
|
1.78 ng/mL
Interval 1.35 to 2.35
|
0.947 ng/mL
Interval 0.661 to 1.36
|
2.31 ng/mL
Interval 1.87 to 2.85
|
|
Plasma Nicotine Concentration-time Profile
30 mins after start of fixed puffing product use
|
2.40 ng/mL
Interval 1.97 to 2.91
|
1.98 ng/mL
Interval 1.57 to 2.51
|
0.931 ng/mL
Interval 0.697 to 1.24
|
2.25 ng/mL
Interval 1.91 to 2.64
|
|
Plasma Nicotine Concentration-time Profile
1 hour after start of fixed puffing product use
|
1.97 ng/mL
Interval 1.6 to 2.42
|
1.71 ng/mL
Interval 1.35 to 2.18
|
0.758 ng/mL
Interval 0.573 to 1.0
|
1.85 ng/mL
Interval 1.57 to 2.19
|
|
Plasma Nicotine Concentration-time Profile
2 hours after start of fixed puffing product use
|
1.20 ng/mL
Interval 0.911 to 1.57
|
1.17 ng/mL
Interval 0.897 to 1.53
|
0.383 ng/mL
Interval 0.241 to 0.607
|
1.23 ng/mL
Interval 1.0 to 1.51
|
|
Plasma Nicotine Concentration-time Profile
4 hours after start of fixed puffing product use
|
0.553 ng/mL
Interval 0.391 to 0.783
|
0.568 ng/mL
Interval 0.398 to 0.812
|
0.219 ng/mL
Interval 0.146 to 0.329
|
0.623 ng/mL
Interval 0.487 to 0.796
|
PRIMARY outcome
Timeframe: 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 4Population: Baseline correction of nicotine concentrations could be performed for 16 out of the 18 randomized subjects
To measure the maximum nicotine plasma concentration \[Cmax\] of four P3P variants from the fixed puffing regimen, following correction of baseline nicotine levels.
Outcome measures
| Measure |
P3P 1
n=16 Participants
2 mg of nicotine; no flavor; nicotine powder particle size of 2.25 ± 0.2 μm
|
P3P 2
n=16 Participants
2 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm
|
P3P 3
n=16 Participants
1 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm
|
P3P 4
n=16 Participants
2 mg of nicotine; flavor; nicotine powder particle size of 1.8 ± 0.2 μm
|
|---|---|---|---|---|
|
Maximum Plasma Concentration [Cmax]
|
3.08 ng/mL
Interval 2.33 to 4.06
|
2.13 ng/mL
Interval 1.62 to 2.81
|
1.14 ng/mL
Interval 0.768 to 1.68
|
2.79 ng/mL
Interval 2.1 to 3.71
|
PRIMARY outcome
Timeframe: 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 4Population: Baseline correction of nicotine concentrations could be performed for 16 out of the 18 randomized subjects.
To measure the time to maximum nicotine concentration \[Tmax\] of four P3P variants from the fixed puffing regimen, following correction of baseline nicotine levels.
Outcome measures
| Measure |
P3P 1
n=16 Participants
2 mg of nicotine; no flavor; nicotine powder particle size of 2.25 ± 0.2 μm
|
P3P 2
n=16 Participants
2 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm
|
P3P 3
n=16 Participants
1 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm
|
P3P 4
n=16 Participants
2 mg of nicotine; flavor; nicotine powder particle size of 1.8 ± 0.2 μm
|
|---|---|---|---|---|
|
Time to the Maximum Nicotine Concentration [Tmax]
|
15.0 minutes
Interval 4.0 to 60.0
|
22.5 minutes
Interval 4.0 to 62.0
|
15.0 minutes
Interval 4.0 to 60.0
|
15.0 minutes
Interval 4.0 to 70.0
|
PRIMARY outcome
Timeframe: 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 4Population: Baseline correction of nicotine concentrations could be performed for 16 out of the 18 randomized subjects.
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.
Outcome measures
| Measure |
P3P 1
n=16 Participants
2 mg of nicotine; no flavor; nicotine powder particle size of 2.25 ± 0.2 μm
|
P3P 2
n=16 Participants
2 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm
|
P3P 3
n=16 Participants
1 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm
|
P3P 4
n=16 Participants
2 mg of nicotine; flavor; nicotine powder particle size of 1.8 ± 0.2 μm
|
|---|---|---|---|---|
|
Area Under the Concentration-time Curve From Start of Product Use (T0 Fix) to 4 Hours [AUCfix (0-4h)]
|
5.84 ng/mL*h
Interval 4.56 to 7.48
|
5.08 ng/mL*h
Interval 3.97 to 6.5
|
2.37 ng/mL*h
Interval 1.67 to 3.37
|
5.73 ng/mL*h
Interval 4.45 to 7.39
|
SECONDARY outcome
Timeframe: 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 4Population: Baseline correction of nicotine concentrations could be performed for 16 out of the 18 randomized subjects.
To measure the plasma nicotine concentration-time profile of four P3P variants from the ad libitum use period, following correction of baseline nicotine levels.
Outcome measures
| Measure |
P3P 1
n=16 Participants
2 mg of nicotine; no flavor; nicotine powder particle size of 2.25 ± 0.2 μm
|
P3P 2
n=16 Participants
2 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm
|
P3P 3
n=16 Participants
1 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm
|
P3P 4
n=16 Participants
2 mg of nicotine; flavor; nicotine powder particle size of 1.8 ± 0.2 μm
|
|---|---|---|---|---|
|
Plasma Nicotine Concentration-time Profile
10 minutes after start of ad libitum product use
|
1.78 ng/mL
Interval 1.25 to 2.53
|
1.48 ng/mL
Interval 1.17 to 1.87
|
0.945 ng/mL
Interval 0.647 to 1.38
|
1.49 ng/mL
Interval 1.01 to 2.19
|
|
Plasma Nicotine Concentration-time Profile
20 minutes after start of ad libitum product use
|
2.31 ng/mL
Interval 1.72 to 3.11
|
2.27 ng/mL
Interval 1.69 to 3.04
|
1.21 ng/mL
Interval 0.981 to 1.5
|
2.06 ng/mL
Interval 1.55 to 2.74
|
|
Plasma Nicotine Concentration-time Profile
30 minutes after start of ad libitum product use
|
3.23 ng/mL
Interval 2.63 to 3.97
|
3.17 ng/mL
Interval 2.5 to 4.01
|
1.68 ng/mL
Interval 1.3 to 2.17
|
2.87 ng/mL
Interval 2.1 to 3.91
|
|
Plasma Nicotine Concentration-time Profile
40 minutes after start of ad libitum product use
|
3.96 ng/mL
Interval 3.13 to 5.02
|
4.05 ng/mL
Interval 3.17 to 5.17
|
1.98 ng/mL
Interval 1.58 to 2.47
|
3.86 ng/mL
Interval 2.88 to 5.18
|
|
Plasma Nicotine Concentration-time Profile
1 hour after start of ad libitum product use
|
5.28 ng/mL
Interval 4.2 to 6.64
|
5.23 ng/mL
Interval 4.15 to 6.58
|
2.67 ng/mL
Interval 2.12 to 3.36
|
4.42 ng/mL
Interval 3.26 to 5.99
|
|
Plasma Nicotine Concentration-time Profile
2 hours after start of ad libitum product use
|
3.91 ng/mL
Interval 2.98 to 5.13
|
4.42 ng/mL
Interval 3.44 to 5.69
|
1.84 ng/mL
Interval 1.39 to 2.42
|
3.61 ng/mL
Interval 2.66 to 4.91
|
|
Plasma Nicotine Concentration-time Profile
4 hours after start of ad libitum product use
|
2.07 ng/mL
Interval 1.55 to 2.77
|
2.35 ng/mL
Interval 1.71 to 3.22
|
0.917 ng/mL
Interval 0.699 to 1.2
|
1.81 ng/mL
Interval 1.38 to 2.38
|
SECONDARY outcome
Timeframe: 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 4Population: Baseline correction of nicotine concentrations could be performed for 16 out of the 18 randomized subjects.
To measure the Peak plasma nicotine concentration \[Cpeak\] of four P3P variants from the ad libitum use period, following correction of baseline nicotine levels.
Outcome measures
| Measure |
P3P 1
n=16 Participants
2 mg of nicotine; no flavor; nicotine powder particle size of 2.25 ± 0.2 μm
|
P3P 2
n=16 Participants
2 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm
|
P3P 3
n=16 Participants
1 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm
|
P3P 4
n=16 Participants
2 mg of nicotine; flavor; nicotine powder particle size of 1.8 ± 0.2 μm
|
|---|---|---|---|---|
|
Peak Plasma Nicotine Concentration [Cpeak]
|
5.38 ng/mL
Interval 4.24 to 6.84
|
5.41 ng/mL
Interval 4.26 to 6.88
|
2.63 ng/mL
Interval 1.97 to 3.52
|
4.67 ng/mL
Interval 3.67 to 5.95
|
SECONDARY outcome
Timeframe: 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 4Population: Baseline correction of nicotine concentrations could be performed for 16 out of the 18 randomized subjects.
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.
Outcome measures
| Measure |
P3P 1
n=16 Participants
2 mg of nicotine; no flavor; nicotine powder particle size of 2.25 ± 0.2 μm
|
P3P 2
n=16 Participants
2 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm
|
P3P 3
n=16 Participants
1 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm
|
P3P 4
n=16 Participants
2 mg of nicotine; flavor; nicotine powder particle size of 1.8 ± 0.2 μm
|
|---|---|---|---|---|
|
Time to Peak Plasma Nicotine Concentration [Tpeak]
|
65.0 minutes
Standard Deviation 22.5
|
82.4 minutes
Standard Deviation 52.1
|
68.0 minutes
Standard Deviation 27.2
|
61.9 minutes
Standard Deviation 24.8
|
SECONDARY outcome
Timeframe: 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 4Population: Baseline correction of nicotine concentrations could be performed for 16 out of the 18 randomized subjects.
To measure the trough plasma nicotine concentration \[Ctrough\] of four P3P variants from the ad libitum use period, following correction of baseline nicotine levels.
Outcome measures
| Measure |
P3P 1
n=16 Participants
2 mg of nicotine; no flavor; nicotine powder particle size of 2.25 ± 0.2 μm
|
P3P 2
n=16 Participants
2 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm
|
P3P 3
n=16 Participants
1 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm
|
P3P 4
n=16 Participants
2 mg of nicotine; flavor; nicotine powder particle size of 1.8 ± 0.2 μm
|
|---|---|---|---|---|
|
Trough Plasma Nicotine Concentration [Ctrough]
|
1.80 ng/mL
Interval 1.32 to 2.45
|
1.58 ng/mL
Interval 1.16 to 2.15
|
1.13 ng/mL
Interval 0.767 to 1.67
|
1.56 ng/mL
Interval 1.14 to 2.13
|
SECONDARY outcome
Timeframe: 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 4Population: Baseline correction of nicotine concentrations could be performed for 16 out of the 18 randomized subjects.
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
Outcome measures
| Measure |
P3P 1
n=16 Participants
2 mg of nicotine; no flavor; nicotine powder particle size of 2.25 ± 0.2 μm
|
P3P 2
n=16 Participants
2 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm
|
P3P 3
n=16 Participants
1 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm
|
P3P 4
n=16 Participants
2 mg of nicotine; flavor; nicotine powder particle size of 1.8 ± 0.2 μm
|
|---|---|---|---|---|
|
Average of Plasma Nicotine Concentration From T0 ad Lib to 1 Hour [Caverage]
|
3.19 ng/mL
Interval 2.53 to 4.02
|
3.13 ng/mL
Interval 2.49 to 3.95
|
1.69 ng/mL
Interval 1.29 to 2.21
|
2.87 ng/mL
Interval 2.27 to 3.62
|
SECONDARY outcome
Timeframe: 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 4Population: Baseline correction of nicotine concentrations could be performed for 16 out of the 18 randomized subjects.
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.
Outcome measures
| Measure |
P3P 1
n=16 Participants
2 mg of nicotine; no flavor; nicotine powder particle size of 2.25 ± 0.2 μm
|
P3P 2
n=16 Participants
2 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm
|
P3P 3
n=16 Participants
1 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm
|
P3P 4
n=16 Participants
2 mg of nicotine; flavor; nicotine powder particle size of 1.8 ± 0.2 μm
|
|---|---|---|---|---|
|
Area Under the Concentration-time Curve From Start of Product Use (T0 ad Lib) to 4 Hours [AUCad Lib (0-4h)]
|
13.6 ng/mL*h
Interval 10.7 to 17.3
|
14.5 ng/mL*h
Interval 11.4 to 18.4
|
6.32 ng/mL*h
Interval 4.73 to 8.44
|
12.1 ng/mL*h
Interval 9.54 to 15.5
|
SECONDARY outcome
Timeframe: During and up to 4 hours post-product use on days 1, 2, 3 and 4Measured on a Visual Analogue Scale (VAS) of 0 (no craving) to 100 (strong craving).
Outcome measures
| Measure |
P3P 1
n=18 Participants
2 mg of nicotine; no flavor; nicotine powder particle size of 2.25 ± 0.2 μm
|
P3P 2
n=18 Participants
2 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm
|
P3P 3
n=18 Participants
1 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm
|
P3P 4
n=18 Participants
2 mg of nicotine; flavor; nicotine powder particle size of 1.8 ± 0.2 μm
|
|---|---|---|---|---|
|
AUC of Craving for a Cigarette During and After the Fixed Puffing Regimen
|
40.1 score on a scale (millimetres)*h
Interval 4.76 to 75.4
|
57.6 score on a scale (millimetres)*h
Interval 22.3 to 92.9
|
116 score on a scale (millimetres)*h
Interval 71.7 to 159.0
|
64.8 score on a scale (millimetres)*h
Interval 29.5 to 100.0
|
SECONDARY outcome
Timeframe: During and up to 4 hours post-product use on days 1, 2, 3 and 4Measured on a Visual Analogue Scale (VAS) of 0 (no craving) to 100 (strong craving).
Outcome measures
| Measure |
P3P 1
n=18 Participants
2 mg of nicotine; no flavor; nicotine powder particle size of 2.25 ± 0.2 μm
|
P3P 2
n=18 Participants
2 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm
|
P3P 3
n=18 Participants
1 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm
|
P3P 4
n=18 Participants
2 mg of nicotine; flavor; nicotine powder particle size of 1.8 ± 0.2 μm
|
|---|---|---|---|---|
|
AUC Craving for a Cigarette During and After the ad Libitum Use Period
|
76.4 score on a scale (millimetres)*h
Interval 36.7 to 116.0
|
72.4 score on a scale (millimetres)*h
Interval 32.7 to 112.0
|
89.6 score on a scale (millimetres)*h
Interval 46.2 to 133.0
|
66.8 score on a scale (millimetres)*h
Interval 27.2 to 107.0
|
SECONDARY outcome
Timeframe: Within 60 minutes after the ad libitum use session on days 1, 2, 3 and 4Measured 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).
Outcome measures
| Measure |
P3P 1
n=18 Participants
2 mg of nicotine; no flavor; nicotine powder particle size of 2.25 ± 0.2 μm
|
P3P 2
n=18 Participants
2 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm
|
P3P 3
n=18 Participants
1 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm
|
P3P 4
n=18 Participants
2 mg of nicotine; flavor; nicotine powder particle size of 1.8 ± 0.2 μm
|
|---|---|---|---|---|
|
Product Evaluation
Psychological Reward
|
3.12 score on a scale
Interval 2.57 to 3.67
|
3.38 score on a scale
Interval 2.82 to 3.93
|
3.21 score on a scale
Interval 2.58 to 3.83
|
3.25 score on a scale
Interval 2.7 to 3.81
|
|
Product Evaluation
Product Satisfaction
|
3.22 score on a scale
Interval 2.68 to 3.76
|
4.40 score on a scale
Interval 3.86 to 4.95
|
4.42 score on a scale
Interval 3.73 to 5.11
|
4.13 score on a scale
Interval 3.58 to 4.67
|
|
Product Evaluation
Enjoyment of Respiratory Tract Sensations
|
2.60 score on a scale
Interval 2.04 to 3.17
|
3.88 score on a scale
Interval 3.32 to 4.44
|
3.75 score on a scale
Interval 3.04 to 4.46
|
3.60 score on a scale
Interval 3.04 to 4.17
|
|
Product Evaluation
Aversion
|
1.23 score on a scale
Interval 0.993 to 1.46
|
1.20 score on a scale
Interval 0.965 to 1.43
|
1.10 score on a scale
Interval 0.754 to 1.44
|
1.03 score on a scale
Interval 0.798 to 1.27
|
|
Product Evaluation
Craving Reduction
|
4.42 score on a scale
Interval 3.78 to 5.05
|
4.58 score on a scale
Interval 3.95 to 5.22
|
4.14 score on a scale
Interval 3.3 to 4.98
|
4.58 score on a scale
Interval 3.95 to 5.22
|
SECONDARY outcome
Timeframe: Within 60 minutes after the ad libitum use session on days 1, 2, 3 and 4Measured 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).
Outcome measures
| Measure |
P3P 1
n=18 Participants
2 mg of nicotine; no flavor; nicotine powder particle size of 2.25 ± 0.2 μm
|
P3P 2
n=18 Participants
2 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm
|
P3P 3
n=18 Participants
1 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm
|
P3P 4
n=18 Participants
2 mg of nicotine; flavor; nicotine powder particle size of 1.8 ± 0.2 μm
|
|---|---|---|---|---|
|
Sensory Parameters
Puffs Similarity to Own Brand
|
2.57 score on a scale
Interval 1.92 to 3.23
|
2.63 score on a scale
Interval 1.97 to 3.29
|
2.78 score on a scale
Interval 2.01 to 3.55
|
2.30 score on a scale
Interval 1.64 to 2.95
|
|
Sensory Parameters
Puffs Strength on Tongue
|
3.44 score on a scale
Interval 2.67 to 4.2
|
3.10 score on a scale
Interval 2.34 to 3.86
|
3.53 score on a scale
Interval 2.61 to 4.44
|
2.88 score on a scale
Interval 2.12 to 3.64
|
|
Sensory Parameters
Puffs Strength in Nose
|
1.89 score on a scale
Interval 1.33 to 2.45
|
1.56 score on a scale
Interval 0.995 to 2.12
|
1.89 score on a scale
Interval 1.23 to 2.55
|
1.72 score on a scale
Interval 1.16 to 2.28
|
|
Sensory Parameters
Puffs Strength in Back of Mouth/Throat
|
4.40 score on a scale
Interval 3.73 to 5.07
|
3.56 score on a scale
Interval 2.9 to 4.23
|
3.69 score on a scale
Interval 2.78 to 4.61
|
3.79 score on a scale
Interval 3.12 to 4.46
|
|
Sensory Parameters
Puff Strength in Windpipe
|
4.38 score on a scale
Interval 3.72 to 5.04
|
3.44 score on a scale
Interval 2.78 to 4.09
|
3.14 score on a scale
Interval 2.25 to 4.02
|
3.77 score on a scale
Interval 3.11 to 4.43
|
|
Sensory Parameters
Puffs Evaluation/Liking
|
3.17 score on a scale
Interval 2.64 to 3.69
|
4.22 score on a scale
Interval 3.7 to 4.75
|
4.22 score on a scale
Interval 3.52 to 4.93
|
3.78 score on a scale
Interval 3.25 to 4.3
|
|
Sensory Parameters
Puffs Harshness
|
4.67 score on a scale
Interval 4.11 to 5.23
|
3.61 score on a scale
Interval 3.05 to 4.17
|
3.67 score on a scale
Interval 2.87 to 4.47
|
3.72 score on a scale
Interval 3.16 to 4.28
|
|
Sensory Parameters
Puff Strength in Chest
|
3.48 score on a scale
Interval 2.75 to 4.21
|
2.81 score on a scale
Interval 2.09 to 3.54
|
2.39 score on a scale
Interval 1.5 to 3.28
|
3.37 score on a scale
Interval 2.64 to 4.1
|
SECONDARY outcome
Timeframe: During fixed puffing product use on days 1, 2, 3 and 4Descriptive statistics of total puff volume and average puff volume, of four P3P variants, during the fixed puffing regimen period.
Outcome measures
| Measure |
P3P 1
n=18 Participants
2 mg of nicotine; no flavor; nicotine powder particle size of 2.25 ± 0.2 μm
|
P3P 2
n=18 Participants
2 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm
|
P3P 3
n=18 Participants
1 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm
|
P3P 4
n=18 Participants
2 mg of nicotine; flavor; nicotine powder particle size of 1.8 ± 0.2 μm
|
|---|---|---|---|---|
|
Human Puffing Topography (HPT) Parameters (Puff Volume) of Four P3P Variants During the Fixed Puffing Regimen Period.
Average Puff Volume (per product)
|
61.0 mL
Interval 52.5 to 70.8
|
66.9 mL
Interval 56.8 to 78.8
|
72.8 mL
Interval 59.7 to 88.9
|
70.4 mL
Interval 61.1 to 81.2
|
|
Human Puffing Topography (HPT) Parameters (Puff Volume) of Four P3P Variants During the Fixed Puffing Regimen Period.
Total Puff Volume (per product)
|
732 mL
Interval 630.0 to 850.0
|
806 mL
Interval 686.0 to 948.0
|
878 mL
Interval 714.0 to 1079.0
|
845 mL
Interval 733.0 to 975.0
|
SECONDARY outcome
Timeframe: During ad libitum product use on days 1, 2, 3 and 4Descriptive statistics of total puff volume and average puff volume, of four P3P variants, during the ad libitum use period.
Outcome measures
| Measure |
P3P 1
n=18 Participants
2 mg of nicotine; no flavor; nicotine powder particle size of 2.25 ± 0.2 μm
|
P3P 2
n=18 Participants
2 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm
|
P3P 3
n=18 Participants
1 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm
|
P3P 4
n=18 Participants
2 mg of nicotine; flavor; nicotine powder particle size of 1.8 ± 0.2 μm
|
|---|---|---|---|---|
|
Human Puffing Topography (HPT) Parameters (Puff Volume) of Four P3P Variants During the ad Libitum Use Period.
Average Puff Volume (per product)
|
57.5 mL
Interval 46.2 to 71.6
|
62.3 mL
Interval 51.2 to 75.9
|
65.4 mL
Interval 56.4 to 75.9
|
62.7 mL
Interval 52.5 to 74.9
|
|
Human Puffing Topography (HPT) Parameters (Puff Volume) of Four P3P Variants During the ad Libitum Use Period.
Total Puff Volume (per product)
|
1485 mL
Interval 1100.0 to 2006.0
|
1559 mL
Interval 1306.0 to 1861.0
|
1598 mL
Interval 1291.0 to 1976.0
|
1512 mL
Interval 1177.0 to 1941.0
|
SECONDARY outcome
Timeframe: Before and after fixed puffing product use on days 1, 2, 3 and 4Descriptive statistics of P3P weight before use, and after use, for the fixed puffing regimen.
Outcome measures
| Measure |
P3P 1
n=18 Participants
2 mg of nicotine; no flavor; nicotine powder particle size of 2.25 ± 0.2 μm
|
P3P 2
n=18 Participants
2 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm
|
P3P 3
n=19 Participants
1 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm
|
P3P 4
n=18 Participants
2 mg of nicotine; flavor; nicotine powder particle size of 1.8 ± 0.2 μm
|
|---|---|---|---|---|
|
Amount of Powder Aerosolized From P3P From the Fixed Puffing Regimen.
Weight before use
|
954 mg
Standard Deviation 2.70
|
965 mg
Standard Deviation 2.11
|
966 mg
Standard Deviation 2.48
|
965 mg
Standard Deviation 2.95
|
|
Amount of Powder Aerosolized From P3P From the Fixed Puffing Regimen.
Weight after use
|
938 mg
Standard Deviation 6.01
|
944 mg
Standard Deviation 6.46
|
943 mg
Standard Deviation 6.46
|
942 mg
Standard Deviation 4.51
|
|
Amount of Powder Aerosolized From P3P From the Fixed Puffing Regimen.
Difference of Weight (Before/After Use)
|
15.6 mg
Standard Deviation 6.16
|
21.6 mg
Standard Deviation 5.89
|
22.6 mg
Standard Deviation 6.07
|
22.2 mg
Standard Deviation 3.14
|
SECONDARY outcome
Timeframe: Before and after ad libitum product use on days 1, 2, 3 and 4P3P weight before use, and after use, to determine the amount of powder aerosolized from P3P during Ad Libitum use (per product used).
Outcome measures
| Measure |
P3P 1
n=18 Participants
2 mg of nicotine; no flavor; nicotine powder particle size of 2.25 ± 0.2 μm
|
P3P 2
n=18 Participants
2 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm
|
P3P 3
n=19 Participants
1 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm
|
P3P 4
n=18 Participants
2 mg of nicotine; flavor; nicotine powder particle size of 1.8 ± 0.2 μm
|
|---|---|---|---|---|
|
Amount of Powder Aerosolized From P3P From the ad Libitum Use Period (Per Product Used).
Average Difference of Weight (Before/After Use)
|
17.0 mg
Standard Deviation 4.17
|
25.9 mg
Standard Deviation 4.63
|
25.6 mg
Standard Deviation 3.92
|
23.9 mg
Standard Deviation 2.66
|
|
Amount of Powder Aerosolized From P3P From the ad Libitum Use Period (Per Product Used).
Average Weight before use
|
954 mg
Standard Deviation 1.83
|
964 mg
Standard Deviation 1.36
|
964 mg
Standard Deviation 1.94
|
964 mg
Standard Deviation 1.59
|
|
Amount of Powder Aerosolized From P3P From the ad Libitum Use Period (Per Product Used).
Average Weight after use
|
937 mg
Standard Deviation 4.69
|
938 mg
Standard Deviation 4.90
|
939 mg
Standard Deviation 4.19
|
940 mg
Standard Deviation 2.28
|
Adverse Events
Safety Population (P3P 1)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Safety Population (P3P 2)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Safety Population (P3P 3)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Safety Population (P3P 4)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Safety Population (P3P 1)
n=18 participants at risk
Comprising enrolled subjects who were exposed to P3P 1 during the study.
|
Safety Population (P3P 2)
n=18 participants at risk
Comprising enrolled subjects who were exposed to P3P 2 during the study.
|
Safety Population (P3P 3)
n=19 participants at risk
Comprising enrolled subjects who were exposed to P3P 3 during the study.
|
Safety Population (P3P 4)
n=18 participants at risk
Comprising enrolled subjects who were exposed to P3P 4 during the study.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
16.7%
3/18 • Number of events 3 • 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.
|
5.6%
1/18 • Number of events 1 • 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.
|
10.5%
2/19 • Number of events 2 • 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.
|
0.00%
0/18 • 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.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/18 • 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.
|
5.6%
1/18 • Number of events 1 • 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.
|
5.3%
1/19 • Number of events 1 • 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.
|
5.6%
1/18 • Number of events 1 • 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.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/18 • 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.
|
5.6%
1/18 • Number of events 1 • 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.
|
0.00%
0/19 • 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.
|
0.00%
0/18 • 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.
|
|
Nervous system disorders
Dizziness
|
11.1%
2/18 • Number of events 2 • 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.
|
11.1%
2/18 • Number of events 2 • 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.
|
10.5%
2/19 • Number of events 2 • 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.
|
11.1%
2/18 • Number of events 2 • 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.
|
|
Nervous system disorders
Headache
|
0.00%
0/18 • 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.
|
0.00%
0/18 • 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.
|
5.3%
1/19 • Number of events 1 • 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.
|
0.00%
0/18 • 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.
|
|
Investigations
Lymphocytes increased
|
5.6%
1/18 • Number of events 1 • 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.
|
5.6%
1/18 • Number of events 1 • 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.
|
0.00%
0/19 • 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.
|
0.00%
0/18 • 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.
|
|
Investigations
Neutrophils decreased
|
0.00%
0/18 • 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.
|
0.00%
0/18 • 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.
|
5.3%
1/19 • Number of events 1 • 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.
|
0.00%
0/18 • 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.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/18 • 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.
|
5.6%
1/18 • Number of events 1 • 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.
|
0.00%
0/19 • 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.
|
0.00%
0/18 • 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.
|
Additional Information
Christelle Haziza, Director Health Science and Biostatistics
Philip Morris Products S.A.
Phone: +41 58 242 11 11
Email: [email protected]
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