Adults 21 to 65, any sex, with Smoking or Nicotine. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Background-corrected Maximum Plasma Concentration [Cmax]Primary· T0 = start of product use. Blood was drawn 5 minutes prior to T0, and then 5, 10, 15, 20, 25, 30, 35, 40 minutes, 1, 3, and 6 hours after T0, on day 1 (morning/afternoon), day 2 (morning/afternoon), and day 3 (morning/afternoon).
To measure the background-corrected maximum plasma concentration \[Cmax\] of 4 variants of NP 1.0 nicotine pouches compared to Velo-NP and Zyn-NP in healthy smokers from a 30 minutes product use period.
Group
Value
95% CI
NP-1
8.109
6.570 – 9.649
NP-2
11.48
9.544 – 13.42
NP-3
2.629
1.670 – 3.588
NP-4
3.464
2.929 – 3.999
Velo-NP
11.32
9.880 – 12.75
Zyn-NP
9.257
8.066 – 10.45
Background-corrected Time to the Maximum Concentration [Tmax]Primary· T0 = start of product use. Blood was drawn 5 minutes prior to T0, and then 5, 10, 15, 20, 25, 30, 35, 40 minutes, 1, 3, and 6 hours after T0, on day 1 (morning/afternoon), day 2 (morning/afternoon), and day 3 (morning/afternoon).
To measure the background-corrected time to the maximum concentration \[Tmax\] of 4 variants of NP 1.0 nicotine pouches compared to Velo-NP and Zyn-NP in healthy smokers from a 30 minutes product use period.
Group
Value
95% CI
NP-1
35.70
10.1 – 179
NP-2
34.80
9.96 – 60.4
NP-3
34.89
9.72 – 60.7
NP-4
34.98
29.8 – 64.3
Velo-NP
33.99
9.72 – 180
Zyn-NP
34.95
22.9 – 59.7
Area Under the Background-corrected Concentration-time Curve (AUC) From Start of Product Use, Extrapolated to Infinity (AUC Infinity)Primary· T0 = start of product use. Blood was drawn 5 minutes prior to T0, and then 5, 10, 15, 20, 25, 30, 35, 40 minutes, 1, 3, and 6 hours after T0, on day 1 (morning/afternoon), day 2 (morning/afternoon), and day 3 (morning/afternoon).
To measure the area under the background-corrected concentration-time curve (AUC) from start of product use of 4 variants of NP 1.0 nicotine pouches compared to Velo-NP and Zyn-NP in healthy smokers from a 30 minutes product use period.
Group
Value
95% CI
NP-1
128.2
97.73 – 158.6
NP-2
217.3
177.6 – 256.9
NP-3
41.35
28.28 – 54.42
NP-4
49.30
40.87 – 57.73
Velo-NP
201.3
173.9 – 228.7
Zyn-NP
136.0
112.6 – 159.3
Score of Cigarette Craving by the Visual Analog Scale (VAS)-Craving AssessmentSecondary· Measured before, and up to 6 hours post-product use on day 1 (morning/afternoon), day 2 (morning/afternoon), and day 3 (morning/afternoon)
To measure cigarette craving by the visual analog scale (VAS)-craving assessment in healthy smokers following a 30 minutes product use period of 4 variants of Nicotine pouch 1.0 compared to Velo-NP and Zyn-NP. Craving was assessed at selected time points on a scale from "no craving" (0 mm) to "strong craving" (100 mm) by measuring the number of millimeters (0-100 mm) from the "no craving" point to the point at which the drawn line intersected the scale.
Pre-Product Use
Group
Value
95% CI
NP-1
61.0
46.7 – 75.2
NP-2
62.6
49.6 – 75.6
NP-3
64.3
51.4 – 77.1
NP-4
67.4
55.0 – 79.8
Velo-NP
68.6
56.8 – 80.4
Zyn-NP
68.9
54.9 – 82.8
5 min Post-Product Use
Group
Value
95% CI
NP-1
38.5
26.5 – 50.6
NP-2
38.1
26.5 – 49.7
NP-3
50.3
38.2 – 62.5
NP-4
42.6
30.8 – 54.4
Velo-NP
38.7
26.8 – 50.7
Zyn-NP
39.4
25.7 – 53.1
10 min Post-Product Use
Group
Value
95% CI
NP-1
36.4
23.1 – 49.7
NP-2
33.8
22.1 – 45.5
NP-3
43.0
29.9 – 56.1
NP-4
38.6
26.9 – 50.3
Velo-NP
34.3
23.2 – 45.5
Zyn-NP
29.0
18.1 – 40.0
15 min Post-Product Use
Group
Value
95% CI
NP-1
27.3
16.8 – 37.7
NP-2
29.9
17.7 – 42.1
NP-3
39.5
26.4 – 52.6
NP-4
36.5
23.8 – 49.3
Velo-NP
31.7
21.1 – 42.3
Zyn-NP
26.9
15.8 – 37.9
20 min Post-Product Use
Group
Value
95% CI
NP-1
29.2
18.5 – 39.9
NP-2
31.7
19.2 – 44.3
NP-3
38.0
24.8 – 51.2
NP-4
36.4
23.8 – 48.9
Velo-NP
26.9
16.4 – 37.3
Zyn-NP
22.7
12.6 – 32.8
25 min Post-Product Use
Group
Value
95% CI
NP-1
29.1
18.2 – 40.1
NP-2
28.6
17.3 – 39.8
NP-3
46.1
32.3 – 59.9
NP-4
35.8
24.4 – 47.3
Velo-NP
24.1
14.6 – 33.5
Zyn-NP
20.0
11.8 – 28.3
30 min Post-Product Use
Group
Value
95% CI
NP-1
28.8
17.0 – 40.6
NP-2
28.3
17.1 – 39.5
NP-3
37.2
24.3 – 50.0
NP-4
35.4
23.5 – 47.3
Velo-NP
24.2
13.7 – 34.8
Zyn-NP
19.5
10.4 – 28.7
35 min Post-Product Use
Group
Value
95% CI
NP-1
27.2
16.2 – 38.1
NP-2
27.1
16.0 – 38.2
NP-3
36.9
23.5 – 50.2
NP-4
33.7
21.0 – 46.4
Velo-NP
23.4
13.5 – 33.2
Zyn-NP
19.5
9.7 – 29.3
Score of "in the Moment" Product Liking by the VAS-liking AssessmentSecondary· Measured up to 1 hour post-product use on day 1 (morning/afternoon), day 2 (morning/afternoon), and day 3 (morning/afternoon)
To measure "in the moment" product liking by the VAS-liking assessment in healthy smokers following a 30 minutes product use period of 4 variants of Nicotine pouch 1.0 compared to Velo-NP and Zyn-NP. Product liking was assessed at selected time points on a scale from "strong disliking" (0 mm) to "strong liking" (100 mm) by measuring the number of millimeters (0-100 mm) from the "strong disliking" point to the point at which the drawn line intersected the scale.
5 min Post-Product Use
Group
Value
95% CI
NP-1
49.7
39.6 – 59.8
NP-2
55.8
48.2 – 63.5
NP-3
50.1
41.0 – 59.2
NP-4
48.2
39.3 – 57.1
Velo-NP
51.7
44.3 – 59.1
Zyn-NP
60.2
51.9 – 68.5
10 min Post-Product Use
Group
Value
95% CI
NP-1
54.8
43.7 – 65.8
NP-2
56.2
45.7 – 66.7
NP-3
52.1
42.8 – 61.4
NP-4
52.1
42.8 – 61.5
Velo-NP
55.8
47.1 – 64.5
Zyn-NP
60.6
50.0 – 71.2
15 min Post-Product Use
Group
Value
95% CI
NP-1
59.2
49.0 – 69.5
NP-2
57.2
45.5 – 68.9
NP-3
52.4
41.7 – 63.1
NP-4
52.7
43.9 – 61.5
Velo-NP
56.1
46.7 – 65.5
Zyn-NP
58.7
47.2 – 70.3
20 min Post-Product Use
Group
Value
95% CI
NP-1
51.5
39.7 – 63.2
NP-2
53.8
41.6 – 66.0
NP-3
52.1
41.4 – 62.8
NP-4
54.5
45.4 – 63.7
Velo-NP
58.7
47.1 – 70.3
Zyn-NP
60.3
47.7 – 72.9
25 min Post-Product Use
Group
Value
95% CI
NP-1
54.6
42.5 – 66.8
NP-2
54.0
42.4 – 65.7
NP-3
51.4
39.7 – 63.1
NP-4
52.7
43.3 – 62.2
Velo-NP
54.7
41.0 – 68.4
Zyn-NP
61.6
49.7 – 73.5
30 min Post-Product Use
Group
Value
95% CI
NP-1
60.0
48.1 – 71.8
NP-2
53.5
40.5 – 66.5
NP-3
52.0
41.5 – 62.6
NP-4
51.7
41.1 – 62.3
Velo-NP
57.7
44.8 – 70.7
Zyn-NP
59.9
47.5 – 72.3
35 min Post-Product Use
Group
Value
95% CI
NP-1
55.2
42.6 – 67.8
NP-2
56.5
44.9 – 68.1
NP-3
51.4
40.4 – 62.3
NP-4
54.0
43.8 – 64.2
Velo-NP
57.0
44.4 – 69.6
Zyn-NP
59.4
45.6 – 73.2
40 min Post-Product Use
Group
Value
95% CI
NP-1
56.7
44.0 – 69.4
NP-2
54.2
42.0 – 66.4
NP-3
51.4
40.3 – 62.6
NP-4
53.6
43.0 – 64.3
Velo-NP
57.2
45.2 – 69.3
Zyn-NP
58.7
45.7 – 71.7
Score of Overall Product Liking by the VAS-liking AssessmentSecondary· Measured after 30 minutes product use on day 1 (morning/afternoon), day 2 (morning/afternoon), and day 3 (morning/afternoon)
To measure overall product liking by the VAS-liking assessment in healthy smokers following a 30 minutes product use period of 4 variants of Nicotine pouch 1.0 compared to Velo-NP and Zyn-NP. Overall product liking was assessed at selected time points on a scale from "strong disliking" (0 mm) to "strong liking" (100 mm) by measuring the number of millimeters (0-100 mm) from the "strong disliking" point to the point at which the drawn line intersected the scale.
Group
Value
95% CI
NP-1
56.5
46.8 – 66.3
NP-2
53.2
44.6 – 61.8
NP-3
49.0
40.1 – 57.9
NP-4
49.5
40.2 – 58.9
Velo-NP
49.9
39.3 – 60.5
Zyn-NP
52.3
40.7 – 64.0
Score of Product Satisfaction by the VAS-satisfaction AssessmentSecondary· Measured on day 1 (morning/afternoon), day 2 (morning/afternoon), and day 3 (morning/afternoon)
To measure product satisfaction by the VAS-satisfaction assessment in healthy smokers following a 30 minutes product use period of 4 variants of Nicotine pouch 1.0 compared to Velo-NP and Zyn-NP. Product satisfaction was was assessed at selected time points on a scale from "not at all" (0 mm) to "extremely" (100 mm) by measuring the number of millimeters (0-100 mm) from the "not at all" point to the point at which the drawn line intersected the scale.
5 min Post-Product Use
Group
Value
95% CI
NP-1
52.5
42.3 – 62.6
NP-2
51.5
41.0 – 62.0
NP-3
45.8
35.8 – 55.8
NP-4
50.2
41.2 – 59.2
Velo-NP
48.4
39.9 – 56.9
Zyn-NP
55.8
45.2 – 66.3
10 min Post-Product Use
Group
Value
95% CI
NP-1
58.0
46.6 – 69.3
NP-2
57.4
46.5 – 68.4
NP-3
48.2
37.4 – 59.1
NP-4
50.0
39.9 – 60.2
Velo-NP
54.5
45.1 – 63.8
Zyn-NP
62.0
52.0 – 72.1
15 min Post-Product Use
Group
Value
95% CI
NP-1
60.9
50.9 – 70.8
NP-2
57.9
46.3 – 69.5
NP-3
50.5
40.3 – 60.8
NP-4
49.5
39.4 – 59.5
Velo-NP
57.5
48.4 – 66.7
Zyn-NP
62.4
50.1 – 74.7
20 min Post-Product Use
Group
Value
95% CI
NP-1
61.1
50.4 – 71.9
NP-2
52.0
38.3 – 65.8
NP-3
49.7
39.0 – 60.4
NP-4
49.3
38.5 – 60.1
Velo-NP
61.0
49.4 – 72.6
Zyn-NP
65.2
53.3 – 77.1
25 min Post-Product Use
Group
Value
95% CI
NP-1
54.2
41.3 – 67.1
NP-2
56.8
46.0 – 67.7
NP-3
50.1
38.8 – 61.4
NP-4
50.8
39.8 – 61.7
Velo-NP
58.2
45.7 – 70.6
Zyn-NP
67.5
55.7 – 79.2
30 min Post-Product Use
Group
Value
95% CI
NP-1
60.6
47.5 – 73.6
NP-2
58.2
46.8 – 69.7
NP-3
50.4
39.4 – 61.4
NP-4
50.2
38.4 – 62.0
Velo-NP
61.6
49.2 – 74.0
Zyn-NP
67.3
54.8 – 79.8
35 min Post-Product Use
Group
Value
95% CI
NP-1
61.2
49.9 – 72.5
NP-2
56.0
44.2 – 67.9
NP-3
46.0
34.6 – 57.5
NP-4
52.9
41.4 – 64.4
Velo-NP
60.4
48.4 – 72.4
Zyn-NP
65.1
53.4 – 76.9
40 min Post-Product Use
Group
Value
95% CI
NP-1
59.0
45.9 – 72.2
NP-2
53.2
40.1 – 66.3
NP-3
44.4
31.8 – 57.0
NP-4
51.7
39.4 – 63.9
Velo-NP
61.4
51.0 – 71.8
Zyn-NP
60.5
47.8 – 73.1
Score of Product Intention to Use Again by the VAS-intention to Use Again AssessmentSecondary· Measured on day 1 (morning/afternoon), day 2 (morning/afternoon), and day 3 (morning/afternoon)
To measure intention to use product again by the VAS-intention to use again assessment in healthy smokers following a 30 minutes product use period of 4 variants of Nicotine pouch 1.0 compared to Velo-NP and Zyn-NP. Intention to use again was was assessed at selected time points on a scale from "very unlikely" (0 mm) to "very likely" (100 mm) by measuring the number of millimeters (0-100 mm) from the "very unlikely" point to the point at which the drawn line intersected the scale.
30 min Post-Product Use
Group
Value
95% CI
NP-1
51.3
37.7 – 64.9
NP-2
52.0
38.8 – 65.1
NP-3
46.7
35.1 – 58.2
NP-4
48.3
36.2 – 60.3
Velo-NP
55.3
42.9 – 67.6
Zyn-NP
57.9
43.2 – 72.6
3 hr Post-Product Use
Group
Value
95% CI
NP-1
48.8
35.6 – 61.9
NP-2
48.1
37.8 – 58.4
NP-3
51.6
42.5 – 60.6
NP-4
44.5
33.0 – 55.9
Velo-NP
50.9
39.5 – 62.2
Zyn-NP
49.5
35.3 – 63.7
Sponsor's own description
This is a single-center, randomized, controlled, open-label, cross-over study in healthy smoking subjects to investigate the nicotine pharmacokinetic (PK) profiles of 4 variants of Nicotine pouch 1.0 compared to marketed Velo - Nicotine Pouch (NP) and Zyn-NP. In addition, pharmacodynamic (PD) effects will be evaluated to provide further insights on Nicotine pouch 1.0 product acceptance and abuse liability. The study will be conducted with 3 periods and 6 sequences in a Williams design (cross-over).
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by Philip Morris Products S.A.
Last refreshed: 27 September 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05317195.