Trial Outcomes & Findings for Pharmacokinetic and Subjective Effects of Heated Tobacco Products (NCT NCT06356610)
NCT ID: NCT06356610
Last Updated: 2026-03-27
Results Overview
Characterize PK parameters of nicotine in plasma during and after a single ad libitum use of HTP (two menthol and two tobacco flavor varieties) test products relative to UBCC and the nicotine gum reference products. Cmax: Maximum measured plasma concentration over the duration of the measurement interval from time zero (defined as the start of product use) to 180 minutes post-use on each Study Day 1 through Day 6.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
80 participants
Primary outcome timeframe
from time zero (defined as the start of product use) to 180 minutes post-use on each Day 1 through Day 6
Results posted on
2026-03-27
Participant Flow
80 participants enrolled in the Product Trial period and 20 participants were dropped out prior to study randomization on Day -1, resulting in 60 participants randomized into study.
Participant milestones
| Measure |
Randomization Sequence 1: ABFCED
Usage of Test and Reference study products in controlled use and ad libitum use sessions during the 6-day in-clinic period in following order:
Test Product A Test Product B Reference Product F Test Product C Reference Product E Test Product D
Test Product A: Use of Test Product A in controlled use and ad libitum use sessions
Test Product B: Use of Test Product B in controlled use and ad libitum use sessions
Test Product C: Use of Test Product C in controlled use and ad libitum use sessions
Test Product D: Use of Test Product D in controlled use and ad libitum use sessions
Reference Product E: Use of Reference Product E in controlled use and ad libitum use sessions
Reference Product F: Use of Reference Product F in controlled use and ad libitum use sessions
|
Randomization Sequence 2: BCADFE
Usage of Test and Reference study products in controlled use and ad libitum use sessions during the 6-day in-clinic period in following order:
Test Product B Test Product C Test Product A Test Product D Reference Product F Reference Product E
Test Product A: Use of Test Product A in controlled use and ad libitum use sessions
Test Product B: Use of Test Product B in controlled use and ad libitum use sessions
Test Product C: Use of Test Product C in controlled use and ad libitum use sessions
Test Product D: Use of Test Product D in controlled use and ad libitum use sessions
Reference Product E: Use of Reference Product E in controlled use and ad libitum use sessions
Reference Product F: Use of Reference Product F in controlled use and ad libitum use sessions
|
Randomization Sequence 3: CDBEAF
Usage of Test and Reference study products in controlled use and ad libitum use sessions during the 6-day in-clinic period in following order:
Test Product C Test Product D Test Product B Reference Product E Test Product A Reference Product F
Test Product A: Use of Test Product A in controlled use and ad libitum use sessions
Test Product B: Use of Test Product B in controlled use and ad libitum use sessions
Test Product C: Use of Test Product C in controlled use and ad libitum use sessions
Test Product D: Use of Test Product D in controlled use and ad libitum use sessions
Reference Product E: Use of Reference Product E in controlled use and ad libitum use sessions
Reference Product F: Use of Reference Product F in controlled use and ad libitum use sessions
|
Randomization Sequence 4: DECFBA
Usage of Test and Reference study products in controlled use and ad libitum use sessions during the 6-day in-clinic period in following order:
Test Product D Reference Product E Test Product C Reference Product F Test Product B Test Product A
Test Product A: Use of Test Product A in controlled use and ad libitum use sessions
Test Product B: Use of Test Product B in controlled use and ad libitum use sessions
Test Product C: Use of Test Product C in controlled use and ad libitum use sessions
Test Product D: Use of Test Product D in controlled use and ad libitum use sessions
Reference Product E: Use of Reference Product E in controlled use and ad libitum use sessions
Reference Product F: Use of Reference Product F in controlled use and ad libitum use sessions
|
Randomization Sequence 5: EFDACB
Usage of Test and Reference study products in controlled use and ad libitum use sessions during the 6-day in-clinic period in following order:
Reference Product E Reference Product F Test Product D Test Product A Test Product C Test Product B
Test Product A: Use of Test Product A in controlled use and ad libitum use sessions
Test Product B: Use of Test Product B in controlled use and ad libitum use sessions
Test Product C: Use of Test Product C in controlled use and ad libitum use sessions
Test Product D: Use of Test Product D in controlled use and ad libitum use sessions
Reference Product E: Use of Reference Product E in controlled use and ad libitum use sessions
Reference Product F: Use of Reference Product F in controlled use and ad libitum use sessions
|
Randomization Sequence 6: FAEBDC
Usage of Test and Reference study products in controlled use and ad libitum use sessions during the 6-day in-clinic period in following order:
Reference Product F Test Product A Reference Product E Test Product B Test Product D Test Product C
Test Product A: Use of Test Product A in controlled use and ad libitum use sessions
Test Product B: Use of Test Product B in controlled use and ad libitum use sessions
Test Product C: Use of Test Product C in controlled use and ad libitum use sessions
Test Product D: Use of Test Product D in controlled use and ad libitum use sessions
Reference Product E: Use of Reference Product E in controlled use and ad libitum use sessions
Reference Product F: Use of Reference Product F in controlled use and ad libitum use sessions
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
11
|
11
|
10
|
10
|
8
|
|
Overall Study
COMPLETED
|
10
|
10
|
9
|
10
|
10
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
2
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacokinetic and Subjective Effects of Heated Tobacco Products
Baseline characteristics by cohort
| Measure |
Randomization Sequence 1: ABFCED
n=10 Participants
Usage of Test and Reference study products in controlled use and ad libitum use sessions during the 6-day in-clinic period in following order:
Test Product A Test Product B Reference Product F Test Product C Reference Product E Test Product D
Test Product A: Use of Test Product A in controlled use and ad libitum use sessions
Test Product B: Use of Test Product B in controlled use and ad libitum use sessions
Test Product C: Use of Test Product C in controlled use and ad libitum use sessions
Test Product D: Use of Test Product D in controlled use and ad libitum use sessions
Reference Product E: Use of Reference Product E in controlled use and ad libitum use sessions
Reference Product F: Use of Reference Product F in controlled use and ad libitum use sessions
|
Randomization Sequence 2: BCADFE
n=11 Participants
Usage of Test and Reference study products in controlled use and ad libitum use sessions during the 6-day in-clinic period in following order:
Test Product B Test Product C Test Product A Test Product D Reference Product F Reference Product E
Test Product A: Use of Test Product A in controlled use and ad libitum use sessions
Test Product B: Use of Test Product B in controlled use and ad libitum use sessions
Test Product C: Use of Test Product C in controlled use and ad libitum use sessions
Test Product D: Use of Test Product D in controlled use and ad libitum use sessions
Reference Product E: Use of Reference Product E in controlled use and ad libitum use sessions
Reference Product F: Use of Reference Product F in controlled use and ad libitum use sessions
|
Randomization Sequence 3: CDBEAF
n=11 Participants
Usage of Test and Reference study products in controlled use and ad libitum use sessions during the 6-day in-clinic period in following order:
Test Product C Test Product D Test Product B Reference Product E Test Product A Reference Product F
Test Product A: Use of Test Product A in controlled use and ad libitum use sessions
Test Product B: Use of Test Product B in controlled use and ad libitum use sessions
Test Product C: Use of Test Product C in controlled use and ad libitum use sessions
Test Product D: Use of Test Product D in controlled use and ad libitum use sessions
Reference Product E: Use of Reference Product E in controlled use and ad libitum use sessions
Reference Product F: Use of Reference Product F in controlled use and ad libitum use sessions
|
Randomization Sequence 4: DECFBA
n=10 Participants
Usage of Test and Reference study products in controlled use and ad libitum use sessions during the 6-day in-clinic period in following order:
Test Product D Reference Product E Test Product C Reference Product F Test Product B Test Product A
Test Product A: Use of Test Product A in controlled use and ad libitum use sessions
Test Product B: Use of Test Product B in controlled use and ad libitum use sessions
Test Product C: Use of Test Product C in controlled use and ad libitum use sessions
Test Product D: Use of Test Product D in controlled use and ad libitum use sessions
Reference Product E: Use of Reference Product E in controlled use and ad libitum use sessions
Reference Product F: Use of Reference Product F in controlled use and ad libitum use sessions
|
Randomization Sequence 5: EFDACB
n=10 Participants
Usage of Test and Reference study products in controlled use and ad libitum use sessions during the 6-day in-clinic period in following order:
Reference Product E Reference Product F Test Product D Test Product A Test Product C Test Product B
Test Product A: Use of Test Product A in controlled use and ad libitum use sessions
Test Product B: Use of Test Product B in controlled use and ad libitum use sessions
Test Product C: Use of Test Product C in controlled use and ad libitum use sessions
Test Product D: Use of Test Product D in controlled use and ad libitum use sessions
Reference Product E: Use of Reference Product E in controlled use and ad libitum use sessions
Reference Product F: Use of Reference Product F in controlled use and ad libitum use sessions
|
Randomization Sequence 6: FAEBDC
n=8 Participants
Usage of Test and Reference study products in controlled use and ad libitum use sessions during the 6-day in-clinic period in following order:
Reference Product F Test Product A Reference Product E Test Product B Test Product D Test Product C
Test Product A: Use of Test Product A in controlled use and ad libitum use sessions
Test Product B: Use of Test Product B in controlled use and ad libitum use sessions
Test Product C: Use of Test Product C in controlled use and ad libitum use sessions
Test Product D: Use of Test Product D in controlled use and ad libitum use sessions
Reference Product E: Use of Reference Product E in controlled use and ad libitum use sessions
Reference Product F: Use of Reference Product F in controlled use and ad libitum use sessions
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Sex: Female, Male
Female
|
5 Participants
n=56 Participants
|
5 Participants
n=62 Participants
|
6 Participants
n=123 Participants
|
5 Participants
n=53 Participants
|
5 Participants
n=654 Participants
|
4 Participants
n=120 Participants
|
30 Participants
n=18 Participants
|
|
Age, Continuous
|
42.3 years
STANDARD_DEVIATION 5.21 • n=56 Participants
|
41.5 years
STANDARD_DEVIATION 5.80 • n=62 Participants
|
35.5 years
STANDARD_DEVIATION 7.99 • n=123 Participants
|
38.0 years
STANDARD_DEVIATION 10.25 • n=53 Participants
|
40.4 years
STANDARD_DEVIATION 8.59 • n=654 Participants
|
36.4 years
STANDARD_DEVIATION 5.34 • n=120 Participants
|
39.1 years
STANDARD_DEVIATION 7.63 • n=18 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=56 Participants
|
6 Participants
n=62 Participants
|
5 Participants
n=123 Participants
|
5 Participants
n=53 Participants
|
5 Participants
n=654 Participants
|
4 Participants
n=120 Participants
|
30 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=56 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=53 Participants
|
1 Participants
n=654 Participants
|
0 Participants
n=120 Participants
|
1 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=56 Participants
|
11 Participants
n=62 Participants
|
11 Participants
n=123 Participants
|
10 Participants
n=53 Participants
|
9 Participants
n=654 Participants
|
8 Participants
n=120 Participants
|
59 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=56 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=53 Participants
|
0 Participants
n=654 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=56 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=53 Participants
|
0 Participants
n=654 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=56 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=53 Participants
|
1 Participants
n=654 Participants
|
0 Participants
n=120 Participants
|
1 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=56 Participants
|
1 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=53 Participants
|
0 Participants
n=654 Participants
|
0 Participants
n=120 Participants
|
1 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=56 Participants
|
4 Participants
n=62 Participants
|
4 Participants
n=123 Participants
|
4 Participants
n=53 Participants
|
4 Participants
n=654 Participants
|
3 Participants
n=120 Participants
|
22 Participants
n=18 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=56 Participants
|
6 Participants
n=62 Participants
|
7 Participants
n=123 Participants
|
6 Participants
n=53 Participants
|
5 Participants
n=654 Participants
|
5 Participants
n=120 Participants
|
36 Participants
n=18 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=56 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=53 Participants
|
0 Participants
n=654 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=56 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=53 Participants
|
0 Participants
n=654 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=18 Participants
|
|
Weight
|
90.61 kg
STANDARD_DEVIATION 20.130 • n=56 Participants
|
101.07 kg
STANDARD_DEVIATION 20.555 • n=62 Participants
|
84.95 kg
STANDARD_DEVIATION 17.024 • n=123 Participants
|
81.09 kg
STANDARD_DEVIATION 20.629 • n=53 Participants
|
90.37 kg
STANDARD_DEVIATION 15.534 • n=654 Participants
|
92.00 kg
STANDARD_DEVIATION 14.806 • n=120 Participants
|
90.05 kg
STANDARD_DEVIATION 18.761 • n=18 Participants
|
|
Height
|
171.4 cm
STANDARD_DEVIATION 8.48 • n=56 Participants
|
176.7 cm
STANDARD_DEVIATION 12.43 • n=62 Participants
|
168.3 cm
STANDARD_DEVIATION 11.27 • n=123 Participants
|
171.1 cm
STANDARD_DEVIATION 8.82 • n=53 Participants
|
169.6 cm
STANDARD_DEVIATION 10.04 • n=654 Participants
|
171.3 cm
STANDARD_DEVIATION 8.36 • n=120 Participants
|
171.4 cm
STANDARD_DEVIATION 10.09 • n=18 Participants
|
|
BMI
|
30.590 kg/m²
STANDARD_DEVIATION 5.2148 • n=56 Participants
|
32.500 kg/m²
STANDARD_DEVIATION 6.2307 • n=62 Participants
|
30.218 kg/m²
STANDARD_DEVIATION 6.3677 • n=123 Participants
|
27.520 kg/m²
STANDARD_DEVIATION 5.7579 • n=53 Participants
|
31.520 kg/m²
STANDARD_DEVIATION 5.3395 • n=654 Participants
|
31.350 kg/m²
STANDARD_DEVIATION 4.2204 • n=120 Participants
|
30.617 kg/m²
STANDARD_DEVIATION 5.6256 • n=18 Participants
|
PRIMARY outcome
Timeframe: from time zero (defined as the start of product use) to 180 minutes post-use on each Day 1 through Day 6Population: Pharmacokinetic (PK) Population: all participants who used any study product and had both product baseline pre-use and at least one post-use plasma nicotine concentration value.
Characterize PK parameters of nicotine in plasma during and after a single ad libitum use of HTP (two menthol and two tobacco flavor varieties) test products relative to UBCC and the nicotine gum reference products. Cmax: Maximum measured plasma concentration over the duration of the measurement interval from time zero (defined as the start of product use) to 180 minutes post-use on each Study Day 1 through Day 6.
Outcome measures
| Measure |
Test Product A
n=57 Participants
Test Product A: Use of Test Product A in controlled use and ad libitum use sessions
|
Test Product B
n=58 Participants
Test Product B: Use of Test Product B in controlled use and ad libitum use sessions
|
Test Product C
n=60 Participants
Test Product C: Use of Test Product C in controlled use and ad libitum use sessions
|
Test Product D
n=59 Participants
Test Product D: Use of Test Product D in controlled use and ad libitum use sessions
|
Reference Product E
n=57 Participants
Reference Product E: Use of Reference Product E in controlled use and ad libitum use sessions
|
Reference Product F
n=57 Participants
Reference Product F: Use of Reference Product F in controlled use and ad libitum use sessions
|
|---|---|---|---|---|---|---|
|
Baseline-adjusted Plasma Nicotine Concentration Pharmacokinetic (PK) Parameters [Cmax] Assessment
|
6.426 ng/mL
Geometric Coefficient of Variation 148.7
|
7.953 ng/mL
Geometric Coefficient of Variation 137.6
|
8.288 ng/mL
Geometric Coefficient of Variation 174.2
|
7.993 ng/mL
Geometric Coefficient of Variation 173.2
|
4.789 ng/mL
Geometric Coefficient of Variation 71.8
|
15.32 ng/mL
Geometric Coefficient of Variation 74.2
|
PRIMARY outcome
Timeframe: from time zero (defined as the start of product use) to 180 minutes post-use on each Study Day 1 through Day 6Population: Pharmacokinetic (PK) Population: all participants who used any study product and had both product baseline pre-use and at least one post-use plasma nicotine concentration value.
Characterize PK parameters of nicotine in plasma during and after a single ad libitum use of HTP (two menthol and two tobacco flavor varieties) test products relative to UBCC and the nicotine gum reference products. AUC(0-180): Area under the nicotine concentration-time curve calculated using linear trapezoidal summation from time zero (defined as the start of product use) to 180 minutes post-use on each Study Day 1 through Day 6.
Outcome measures
| Measure |
Test Product A
n=57 Participants
Test Product A: Use of Test Product A in controlled use and ad libitum use sessions
|
Test Product B
n=58 Participants
Test Product B: Use of Test Product B in controlled use and ad libitum use sessions
|
Test Product C
n=60 Participants
Test Product C: Use of Test Product C in controlled use and ad libitum use sessions
|
Test Product D
n=59 Participants
Test Product D: Use of Test Product D in controlled use and ad libitum use sessions
|
Reference Product E
n=57 Participants
Reference Product E: Use of Reference Product E in controlled use and ad libitum use sessions
|
Reference Product F
n=57 Participants
Reference Product F: Use of Reference Product F in controlled use and ad libitum use sessions
|
|---|---|---|---|---|---|---|
|
Baseline-adjusted Plasma Nicotine Concentration Pharmacokinetic (PK) Parameter [AUC(0-180)] Assessment
|
414.1 ng*min/mL
Geometric Coefficient of Variation 101.5
|
486.4 ng*min/mL
Geometric Coefficient of Variation 120.6
|
524.9 ng*min/mL
Geometric Coefficient of Variation 112.6
|
524.2 ng*min/mL
Geometric Coefficient of Variation 124.1
|
522.7 ng*min/mL
Geometric Coefficient of Variation 71.8
|
988.0 ng*min/mL
Geometric Coefficient of Variation 48.0
|
PRIMARY outcome
Timeframe: Day 1 through Day 6Population: Pharmacokinetic (PK) Population: all participants who used any study product and had both product baseline pre-use and at least one post-use plasma nicotine concentration value.
Characterize PK parameters of nicotine in plasma during and after a single ad libitum use of HTP (two menthol and two tobacco flavor varieties) test products relative to UBCC and the nicotine gum reference products. Tmax: Time of the maximum measured plasma concentration over the duration of the measurement interval.
Outcome measures
| Measure |
Test Product A
n=57 Participants
Test Product A: Use of Test Product A in controlled use and ad libitum use sessions
|
Test Product B
n=58 Participants
Test Product B: Use of Test Product B in controlled use and ad libitum use sessions
|
Test Product C
n=60 Participants
Test Product C: Use of Test Product C in controlled use and ad libitum use sessions
|
Test Product D
n=59 Participants
Test Product D: Use of Test Product D in controlled use and ad libitum use sessions
|
Reference Product E
n=57 Participants
Reference Product E: Use of Reference Product E in controlled use and ad libitum use sessions
|
Reference Product F
n=57 Participants
Reference Product F: Use of Reference Product F in controlled use and ad libitum use sessions
|
|---|---|---|---|---|---|---|
|
Baseline-adjusted Plasma Nicotine Concentration Pharmacokinetic (PK) Parameter [Tmax] Assessment
|
6.800 min
Interval 2.73 to 59.0
|
6.967 min
Interval 4.5 to 175.02
|
7.000 min
Interval 3.0 to 180.3
|
6.900 min
Interval 3.0 to 180.0
|
45.000 min
Interval 29.52 to 175.3
|
7.000 min
Interval 2.72 to 15.02
|
OTHER_PRE_SPECIFIED outcome
Timeframe: from 5 minutes to 180 minutes after the start of each morning ad libitum product use on Study Day 1 through Day 6Population: Subjective Measures Population: all participants who used any study product and had specified questionnaire response scores.
Product Liking (PL) Questionnaire Response VAS Score Parameter \[Emax-PL\] Assessment during and following the morning ad libitum product use PK test session. Emax-PL: Maximum value of the VAS score across all timepoints for product liking subjective measure from 5 minutes to 180 minutes after the start of each morning ad libitum product use. VAS: Visual analog scale of 0-100mm, where 0 as "strongly dislike" and 100 as "strongly like".
Outcome measures
| Measure |
Test Product A
n=58 Participants
Test Product A: Use of Test Product A in controlled use and ad libitum use sessions
|
Test Product B
n=57 Participants
Test Product B: Use of Test Product B in controlled use and ad libitum use sessions
|
Test Product C
n=60 Participants
Test Product C: Use of Test Product C in controlled use and ad libitum use sessions
|
Test Product D
n=59 Participants
Test Product D: Use of Test Product D in controlled use and ad libitum use sessions
|
Reference Product E
n=57 Participants
Reference Product E: Use of Reference Product E in controlled use and ad libitum use sessions
|
Reference Product F
n=57 Participants
Reference Product F: Use of Reference Product F in controlled use and ad libitum use sessions
|
|---|---|---|---|---|---|---|
|
Main Outcome of Product Liking Questionnaire Response VAS Score Parameter [Emax-PL] Assessment
|
65.2 mm
Standard Deviation 28.83
|
66.7 mm
Standard Deviation 25.48
|
59.0 mm
Standard Deviation 29.20
|
60.1 mm
Standard Deviation 28.06
|
55.9 mm
Standard Deviation 24.48
|
86.5 mm
Standard Deviation 20.00
|
Adverse Events
Study Product Trial
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Test Product A
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Test Product B
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Test Product C
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Test Product D
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Reference Product E
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Reference Product F
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Study Product Trial
n=80 participants at risk
The Product Trial period includes the at home product trial up until the first ad libitum use on Day -1.
|
Test Product A
n=58 participants at risk
Test Product A: Use of Test Product A in controlled use and ad libitum use sessions
|
Test Product B
n=58 participants at risk
Test Product B: Use of Test Product B in controlled use and ad libitum use sessions
|
Test Product C
n=60 participants at risk
Test Product C: Use of Test Product C in controlled use and ad libitum use sessions
|
Test Product D
n=59 participants at risk
Test Product D: Use of Test Product D in controlled use and ad libitum use sessions
|
Reference Product E
n=57 participants at risk
Reference Product E: Use of Reference Product E in controlled use and ad libitum use sessions
|
Reference Product F
n=57 participants at risk
Reference Product F: Use of Reference Product F in controlled use and ad libitum use sessions
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Dyspepsia
|
1.2%
1/80 • Number of events 1 • Adverse event data were collected during Study Day -6 to Day -2 (At-home Product Trial) period, as well as Clinic Study Day -1 to Day 6 or EOS, for a total up to 12 days.
|
0.00%
0/58 • Adverse event data were collected during Study Day -6 to Day -2 (At-home Product Trial) period, as well as Clinic Study Day -1 to Day 6 or EOS, for a total up to 12 days.
|
1.7%
1/58 • Number of events 1 • Adverse event data were collected during Study Day -6 to Day -2 (At-home Product Trial) period, as well as Clinic Study Day -1 to Day 6 or EOS, for a total up to 12 days.
|
0.00%
0/60 • Adverse event data were collected during Study Day -6 to Day -2 (At-home Product Trial) period, as well as Clinic Study Day -1 to Day 6 or EOS, for a total up to 12 days.
|
0.00%
0/59 • Adverse event data were collected during Study Day -6 to Day -2 (At-home Product Trial) period, as well as Clinic Study Day -1 to Day 6 or EOS, for a total up to 12 days.
|
5.3%
3/57 • Number of events 4 • Adverse event data were collected during Study Day -6 to Day -2 (At-home Product Trial) period, as well as Clinic Study Day -1 to Day 6 or EOS, for a total up to 12 days.
|
0.00%
0/57 • Adverse event data were collected during Study Day -6 to Day -2 (At-home Product Trial) period, as well as Clinic Study Day -1 to Day 6 or EOS, for a total up to 12 days.
|
|
Eye disorders
Eye pruritus
|
0.00%
0/80 • Adverse event data were collected during Study Day -6 to Day -2 (At-home Product Trial) period, as well as Clinic Study Day -1 to Day 6 or EOS, for a total up to 12 days.
|
0.00%
0/58 • Adverse event data were collected during Study Day -6 to Day -2 (At-home Product Trial) period, as well as Clinic Study Day -1 to Day 6 or EOS, for a total up to 12 days.
|
0.00%
0/58 • Adverse event data were collected during Study Day -6 to Day -2 (At-home Product Trial) period, as well as Clinic Study Day -1 to Day 6 or EOS, for a total up to 12 days.
|
0.00%
0/60 • Adverse event data were collected during Study Day -6 to Day -2 (At-home Product Trial) period, as well as Clinic Study Day -1 to Day 6 or EOS, for a total up to 12 days.
|
0.00%
0/59 • Adverse event data were collected during Study Day -6 to Day -2 (At-home Product Trial) period, as well as Clinic Study Day -1 to Day 6 or EOS, for a total up to 12 days.
|
0.00%
0/57 • Adverse event data were collected during Study Day -6 to Day -2 (At-home Product Trial) period, as well as Clinic Study Day -1 to Day 6 or EOS, for a total up to 12 days.
|
1.8%
1/57 • Number of events 1 • Adverse event data were collected during Study Day -6 to Day -2 (At-home Product Trial) period, as well as Clinic Study Day -1 to Day 6 or EOS, for a total up to 12 days.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/80 • Adverse event data were collected during Study Day -6 to Day -2 (At-home Product Trial) period, as well as Clinic Study Day -1 to Day 6 or EOS, for a total up to 12 days.
|
1.7%
1/58 • Number of events 1 • Adverse event data were collected during Study Day -6 to Day -2 (At-home Product Trial) period, as well as Clinic Study Day -1 to Day 6 or EOS, for a total up to 12 days.
|
0.00%
0/58 • Adverse event data were collected during Study Day -6 to Day -2 (At-home Product Trial) period, as well as Clinic Study Day -1 to Day 6 or EOS, for a total up to 12 days.
|
0.00%
0/60 • Adverse event data were collected during Study Day -6 to Day -2 (At-home Product Trial) period, as well as Clinic Study Day -1 to Day 6 or EOS, for a total up to 12 days.
|
0.00%
0/59 • Adverse event data were collected during Study Day -6 to Day -2 (At-home Product Trial) period, as well as Clinic Study Day -1 to Day 6 or EOS, for a total up to 12 days.
|
1.8%
1/57 • Number of events 2 • Adverse event data were collected during Study Day -6 to Day -2 (At-home Product Trial) period, as well as Clinic Study Day -1 to Day 6 or EOS, for a total up to 12 days.
|
0.00%
0/57 • Adverse event data were collected during Study Day -6 to Day -2 (At-home Product Trial) period, as well as Clinic Study Day -1 to Day 6 or EOS, for a total up to 12 days.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/80 • Adverse event data were collected during Study Day -6 to Day -2 (At-home Product Trial) period, as well as Clinic Study Day -1 to Day 6 or EOS, for a total up to 12 days.
|
1.7%
1/58 • Number of events 1 • Adverse event data were collected during Study Day -6 to Day -2 (At-home Product Trial) period, as well as Clinic Study Day -1 to Day 6 or EOS, for a total up to 12 days.
|
0.00%
0/58 • Adverse event data were collected during Study Day -6 to Day -2 (At-home Product Trial) period, as well as Clinic Study Day -1 to Day 6 or EOS, for a total up to 12 days.
|
0.00%
0/60 • Adverse event data were collected during Study Day -6 to Day -2 (At-home Product Trial) period, as well as Clinic Study Day -1 to Day 6 or EOS, for a total up to 12 days.
|
0.00%
0/59 • Adverse event data were collected during Study Day -6 to Day -2 (At-home Product Trial) period, as well as Clinic Study Day -1 to Day 6 or EOS, for a total up to 12 days.
|
0.00%
0/57 • Adverse event data were collected during Study Day -6 to Day -2 (At-home Product Trial) period, as well as Clinic Study Day -1 to Day 6 or EOS, for a total up to 12 days.
|
0.00%
0/57 • Adverse event data were collected during Study Day -6 to Day -2 (At-home Product Trial) period, as well as Clinic Study Day -1 to Day 6 or EOS, for a total up to 12 days.
|
|
Investigations
Blood pressure increased
|
1.2%
1/80 • Number of events 1 • Adverse event data were collected during Study Day -6 to Day -2 (At-home Product Trial) period, as well as Clinic Study Day -1 to Day 6 or EOS, for a total up to 12 days.
|
0.00%
0/58 • Adverse event data were collected during Study Day -6 to Day -2 (At-home Product Trial) period, as well as Clinic Study Day -1 to Day 6 or EOS, for a total up to 12 days.
|
0.00%
0/58 • Adverse event data were collected during Study Day -6 to Day -2 (At-home Product Trial) period, as well as Clinic Study Day -1 to Day 6 or EOS, for a total up to 12 days.
|
0.00%
0/60 • Adverse event data were collected during Study Day -6 to Day -2 (At-home Product Trial) period, as well as Clinic Study Day -1 to Day 6 or EOS, for a total up to 12 days.
|
0.00%
0/59 • Adverse event data were collected during Study Day -6 to Day -2 (At-home Product Trial) period, as well as Clinic Study Day -1 to Day 6 or EOS, for a total up to 12 days.
|
0.00%
0/57 • Adverse event data were collected during Study Day -6 to Day -2 (At-home Product Trial) period, as well as Clinic Study Day -1 to Day 6 or EOS, for a total up to 12 days.
|
0.00%
0/57 • Adverse event data were collected during Study Day -6 to Day -2 (At-home Product Trial) period, as well as Clinic Study Day -1 to Day 6 or EOS, for a total up to 12 days.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/80 • Adverse event data were collected during Study Day -6 to Day -2 (At-home Product Trial) period, as well as Clinic Study Day -1 to Day 6 or EOS, for a total up to 12 days.
|
0.00%
0/58 • Adverse event data were collected during Study Day -6 to Day -2 (At-home Product Trial) period, as well as Clinic Study Day -1 to Day 6 or EOS, for a total up to 12 days.
|
0.00%
0/58 • Adverse event data were collected during Study Day -6 to Day -2 (At-home Product Trial) period, as well as Clinic Study Day -1 to Day 6 or EOS, for a total up to 12 days.
|
0.00%
0/60 • Adverse event data were collected during Study Day -6 to Day -2 (At-home Product Trial) period, as well as Clinic Study Day -1 to Day 6 or EOS, for a total up to 12 days.
|
0.00%
0/59 • Adverse event data were collected during Study Day -6 to Day -2 (At-home Product Trial) period, as well as Clinic Study Day -1 to Day 6 or EOS, for a total up to 12 days.
|
1.8%
1/57 • Number of events 1 • Adverse event data were collected during Study Day -6 to Day -2 (At-home Product Trial) period, as well as Clinic Study Day -1 to Day 6 or EOS, for a total up to 12 days.
|
0.00%
0/57 • Adverse event data were collected during Study Day -6 to Day -2 (At-home Product Trial) period, as well as Clinic Study Day -1 to Day 6 or EOS, for a total up to 12 days.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/80 • Adverse event data were collected during Study Day -6 to Day -2 (At-home Product Trial) period, as well as Clinic Study Day -1 to Day 6 or EOS, for a total up to 12 days.
|
0.00%
0/58 • Adverse event data were collected during Study Day -6 to Day -2 (At-home Product Trial) period, as well as Clinic Study Day -1 to Day 6 or EOS, for a total up to 12 days.
|
0.00%
0/58 • Adverse event data were collected during Study Day -6 to Day -2 (At-home Product Trial) period, as well as Clinic Study Day -1 to Day 6 or EOS, for a total up to 12 days.
|
0.00%
0/60 • Adverse event data were collected during Study Day -6 to Day -2 (At-home Product Trial) period, as well as Clinic Study Day -1 to Day 6 or EOS, for a total up to 12 days.
|
0.00%
0/59 • Adverse event data were collected during Study Day -6 to Day -2 (At-home Product Trial) period, as well as Clinic Study Day -1 to Day 6 or EOS, for a total up to 12 days.
|
1.8%
1/57 • Number of events 1 • Adverse event data were collected during Study Day -6 to Day -2 (At-home Product Trial) period, as well as Clinic Study Day -1 to Day 6 or EOS, for a total up to 12 days.
|
0.00%
0/57 • Adverse event data were collected during Study Day -6 to Day -2 (At-home Product Trial) period, as well as Clinic Study Day -1 to Day 6 or EOS, for a total up to 12 days.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/80 • Adverse event data were collected during Study Day -6 to Day -2 (At-home Product Trial) period, as well as Clinic Study Day -1 to Day 6 or EOS, for a total up to 12 days.
|
1.7%
1/58 • Number of events 1 • Adverse event data were collected during Study Day -6 to Day -2 (At-home Product Trial) period, as well as Clinic Study Day -1 to Day 6 or EOS, for a total up to 12 days.
|
1.7%
1/58 • Number of events 1 • Adverse event data were collected during Study Day -6 to Day -2 (At-home Product Trial) period, as well as Clinic Study Day -1 to Day 6 or EOS, for a total up to 12 days.
|
0.00%
0/60 • Adverse event data were collected during Study Day -6 to Day -2 (At-home Product Trial) period, as well as Clinic Study Day -1 to Day 6 or EOS, for a total up to 12 days.
|
0.00%
0/59 • Adverse event data were collected during Study Day -6 to Day -2 (At-home Product Trial) period, as well as Clinic Study Day -1 to Day 6 or EOS, for a total up to 12 days.
|
0.00%
0/57 • Adverse event data were collected during Study Day -6 to Day -2 (At-home Product Trial) period, as well as Clinic Study Day -1 to Day 6 or EOS, for a total up to 12 days.
|
0.00%
0/57 • Adverse event data were collected during Study Day -6 to Day -2 (At-home Product Trial) period, as well as Clinic Study Day -1 to Day 6 or EOS, for a total up to 12 days.
|
|
Nervous system disorders
Headache
|
0.00%
0/80 • Adverse event data were collected during Study Day -6 to Day -2 (At-home Product Trial) period, as well as Clinic Study Day -1 to Day 6 or EOS, for a total up to 12 days.
|
0.00%
0/58 • Adverse event data were collected during Study Day -6 to Day -2 (At-home Product Trial) period, as well as Clinic Study Day -1 to Day 6 or EOS, for a total up to 12 days.
|
1.7%
1/58 • Number of events 1 • Adverse event data were collected during Study Day -6 to Day -2 (At-home Product Trial) period, as well as Clinic Study Day -1 to Day 6 or EOS, for a total up to 12 days.
|
3.3%
2/60 • Number of events 2 • Adverse event data were collected during Study Day -6 to Day -2 (At-home Product Trial) period, as well as Clinic Study Day -1 to Day 6 or EOS, for a total up to 12 days.
|
1.7%
1/59 • Number of events 1 • Adverse event data were collected during Study Day -6 to Day -2 (At-home Product Trial) period, as well as Clinic Study Day -1 to Day 6 or EOS, for a total up to 12 days.
|
0.00%
0/57 • Adverse event data were collected during Study Day -6 to Day -2 (At-home Product Trial) period, as well as Clinic Study Day -1 to Day 6 or EOS, for a total up to 12 days.
|
0.00%
0/57 • Adverse event data were collected during Study Day -6 to Day -2 (At-home Product Trial) period, as well as Clinic Study Day -1 to Day 6 or EOS, for a total up to 12 days.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/80 • Adverse event data were collected during Study Day -6 to Day -2 (At-home Product Trial) period, as well as Clinic Study Day -1 to Day 6 or EOS, for a total up to 12 days.
|
0.00%
0/58 • Adverse event data were collected during Study Day -6 to Day -2 (At-home Product Trial) period, as well as Clinic Study Day -1 to Day 6 or EOS, for a total up to 12 days.
|
0.00%
0/58 • Adverse event data were collected during Study Day -6 to Day -2 (At-home Product Trial) period, as well as Clinic Study Day -1 to Day 6 or EOS, for a total up to 12 days.
|
0.00%
0/60 • Adverse event data were collected during Study Day -6 to Day -2 (At-home Product Trial) period, as well as Clinic Study Day -1 to Day 6 or EOS, for a total up to 12 days.
|
0.00%
0/59 • Adverse event data were collected during Study Day -6 to Day -2 (At-home Product Trial) period, as well as Clinic Study Day -1 to Day 6 or EOS, for a total up to 12 days.
|
1.8%
1/57 • Number of events 1 • Adverse event data were collected during Study Day -6 to Day -2 (At-home Product Trial) period, as well as Clinic Study Day -1 to Day 6 or EOS, for a total up to 12 days.
|
0.00%
0/57 • Adverse event data were collected during Study Day -6 to Day -2 (At-home Product Trial) period, as well as Clinic Study Day -1 to Day 6 or EOS, for a total up to 12 days.
|
|
Vascular disorders
Haematoma
|
0.00%
0/80 • Adverse event data were collected during Study Day -6 to Day -2 (At-home Product Trial) period, as well as Clinic Study Day -1 to Day 6 or EOS, for a total up to 12 days.
|
0.00%
0/58 • Adverse event data were collected during Study Day -6 to Day -2 (At-home Product Trial) period, as well as Clinic Study Day -1 to Day 6 or EOS, for a total up to 12 days.
|
0.00%
0/58 • Adverse event data were collected during Study Day -6 to Day -2 (At-home Product Trial) period, as well as Clinic Study Day -1 to Day 6 or EOS, for a total up to 12 days.
|
0.00%
0/60 • Adverse event data were collected during Study Day -6 to Day -2 (At-home Product Trial) period, as well as Clinic Study Day -1 to Day 6 or EOS, for a total up to 12 days.
|
0.00%
0/59 • Adverse event data were collected during Study Day -6 to Day -2 (At-home Product Trial) period, as well as Clinic Study Day -1 to Day 6 or EOS, for a total up to 12 days.
|
1.8%
1/57 • Number of events 1 • Adverse event data were collected during Study Day -6 to Day -2 (At-home Product Trial) period, as well as Clinic Study Day -1 to Day 6 or EOS, for a total up to 12 days.
|
0.00%
0/57 • Adverse event data were collected during Study Day -6 to Day -2 (At-home Product Trial) period, as well as Clinic Study Day -1 to Day 6 or EOS, for a total up to 12 days.
|
Additional Information
Jeffery Edmiston, ALCS Clinical Research, Functional Director
Altria
Phone: 8043352366
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place