Trial Outcomes & Findings for Single-dose Nicotine Pharmacokinetics With a New Oral Nicotine Replacement Product (NCT NCT01084603)
NCT ID: NCT01084603
Last Updated: 2012-07-13
Results Overview
Cmax, which is the maximum (peak) concentration (amount of drug) measurable in blood plasma after a dose is administered measured in nanograms/milliliter (ng/ml)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
45 participants
Primary outcome timeframe
During 12 hours after start of administration
Results posted on
2012-07-13
Participant Flow
Participant milestones
| Measure |
Overall Study
Full Safety Set
|
|---|---|
|
Baseline
STARTED
|
45
|
|
Baseline
COMPLETED
|
43
|
|
Baseline
NOT COMPLETED
|
2
|
|
NiQuitinTM Lozenge
STARTED
|
43
|
|
NiQuitinTM Lozenge
COMPLETED
|
42
|
|
NiQuitinTM Lozenge
NOT COMPLETED
|
1
|
|
Washout Period 1
STARTED
|
42
|
|
Washout Period 1
COMPLETED
|
42
|
|
Washout Period 1
NOT COMPLETED
|
0
|
|
Nicorette® Gum
STARTED
|
42
|
|
Nicorette® Gum
COMPLETED
|
41
|
|
Nicorette® Gum
NOT COMPLETED
|
1
|
|
Washout Period 2
STARTED
|
41
|
|
Washout Period 2
COMPLETED
|
41
|
|
Washout Period 2
NOT COMPLETED
|
0
|
|
Oral Nicotine 1
STARTED
|
41
|
|
Oral Nicotine 1
COMPLETED
|
40
|
|
Oral Nicotine 1
NOT COMPLETED
|
1
|
|
Washout Period 3
STARTED
|
40
|
|
Washout Period 3
COMPLETED
|
40
|
|
Washout Period 3
NOT COMPLETED
|
0
|
|
Oral Nicotine 2
STARTED
|
40
|
|
Oral Nicotine 2
COMPLETED
|
40
|
|
Oral Nicotine 2
NOT COMPLETED
|
0
|
|
Washout Period 4
STARTED
|
40
|
|
Washout Period 4
COMPLETED
|
39
|
|
Washout Period 4
NOT COMPLETED
|
1
|
|
Oral Nicotine 4
STARTED
|
39
|
|
Oral Nicotine 4
COMPLETED
|
39
|
|
Oral Nicotine 4
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
Overall Study
Full Safety Set
|
|---|---|
|
Baseline
Withdrawal by Subject
|
2
|
|
NiQuitinTM Lozenge
Withdrawal by Subject
|
1
|
|
Nicorette® Gum
Withdrawal by Subject
|
1
|
|
Oral Nicotine 1
Withdrawal by Subject
|
1
|
|
Washout Period 4
Adverse Event
|
1
|
Baseline Characteristics
Single-dose Nicotine Pharmacokinetics With a New Oral Nicotine Replacement Product
Baseline characteristics by cohort
| Measure |
Overall Study
n=45 Participants
Full Safety Set
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
45 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
45 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During 12 hours after start of administrationPopulation: ITT
Cmax, which is the maximum (peak) concentration (amount of drug) measurable in blood plasma after a dose is administered measured in nanograms/milliliter (ng/ml)
Outcome measures
| Measure |
Oral Nicotine 1
n=40 Participants
1 administration of 1 mg
|
Oral Nicotine 2
n=40 Participants
2 administrations of 1 mg
|
Nicorette® Gum 4 mg
n=41 Participants
One marketed Nicorette® nicotine gum 4 mg chewed for 30 minutes
|
Oral Nicotine 4
n=39 Participants
4 administrations of 1 mg
|
NiQuitinTM Lozenge 4 mg
n=42 Participants
1 NiQuitinTM nicotine lozenge 4 mg
|
|---|---|---|---|---|---|
|
Maximum Plasma Concentration
|
3.04 (ng/ml)
Standard Deviation 1.47
|
4.94 (ng/ml)
Standard Deviation 2.06
|
7.36 (ng/ml)
Standard Deviation 2.66
|
8.63 (ng/ml)
Standard Deviation 2.96
|
6.44 (ng/ml)
Standard Deviation 2.06
|
PRIMARY outcome
Timeframe: 12 hoursA measure of how much of the drug reaches a person's bloodstream within a given period of time for the body to use. The extent of product bioavailability is estimated by the area under the blood concentration vs time curve. The area under the curve (AUC) is calculated by plotting the drug's blood levels on a graph at different times during the set period to form a curve. The area under this curve reflects the amount of drug exposure in the set time period, calculated as hour\*nanograms/milliliter (h\*ng/ml).
Outcome measures
| Measure |
Oral Nicotine 1
n=40 Participants
1 administration of 1 mg
|
Oral Nicotine 2
n=40 Participants
2 administrations of 1 mg
|
Nicorette® Gum 4 mg
n=41 Participants
One marketed Nicorette® nicotine gum 4 mg chewed for 30 minutes
|
Oral Nicotine 4
n=39 Participants
4 administrations of 1 mg
|
NiQuitinTM Lozenge 4 mg
n=42 Participants
1 NiQuitinTM nicotine lozenge 4 mg
|
|---|---|---|---|---|---|
|
Bioavailability
AUC to last measurable concentration
|
5.85 h*ng/ml
Standard Deviation 3.7
|
11.50 h*ng/ml
Standard Deviation 3.98
|
19.69 h*ng/ml
Standard Deviation 7.95
|
21.96 h*ng/ml
Standard Deviation 9.00
|
22.00 h*ng/ml
Standard Deviation 11.05
|
|
Bioavailability
AUC to infinity
|
7.54 h*ng/ml
Standard Deviation 4.10
|
13.30 h*ng/ml
Standard Deviation 4.20
|
21.62 h*ng/ml
Standard Deviation 8.43
|
24.10 h*ng/ml
Standard Deviation 9.35
|
24.30 h*ng/ml
Standard Deviation 11.91
|
SECONDARY outcome
Timeframe: During 10 minutes after start of administrationPopulation: ITT
Area under the nicotine plasma concentration curve at 10 minutes (AUC10 min)
Outcome measures
| Measure |
Oral Nicotine 1
n=40 Participants
1 administration of 1 mg
|
Oral Nicotine 2
n=40 Participants
2 administrations of 1 mg
|
Nicorette® Gum 4 mg
n=41 Participants
One marketed Nicorette® nicotine gum 4 mg chewed for 30 minutes
|
Oral Nicotine 4
n=39 Participants
4 administrations of 1 mg
|
NiQuitinTM Lozenge 4 mg
n=42 Participants
1 NiQuitinTM nicotine lozenge 4 mg
|
|---|---|---|---|---|---|
|
Nicotine Plasma Concentration
|
0.43 (h*ng/ml)
Standard Deviation 0.23
|
0.56 (h*ng/ml)
Standard Deviation 0.33
|
0.29 (h*ng/ml)
Standard Deviation 0.20
|
0.87 (h*ng/ml)
Standard Deviation 0.42
|
0.29 (h*ng/ml)
Standard Deviation 0.20
|
SECONDARY outcome
Timeframe: During 12 hours after start of administrationPopulation: ITT
The time at which maximum concentration is reached (Tmax)
Outcome measures
| Measure |
Oral Nicotine 1
n=40 Participants
1 administration of 1 mg
|
Oral Nicotine 2
n=40 Participants
2 administrations of 1 mg
|
Nicorette® Gum 4 mg
n=41 Participants
One marketed Nicorette® nicotine gum 4 mg chewed for 30 minutes
|
Oral Nicotine 4
n=39 Participants
4 administrations of 1 mg
|
NiQuitinTM Lozenge 4 mg
n=42 Participants
1 NiQuitinTM nicotine lozenge 4 mg
|
|---|---|---|---|---|---|
|
Time of Maximum Concentration
|
0.17 (hours)
Interval 0.07 to 1.5
|
0.21 (hours)
Interval 0.07 to 1.0
|
0.50 (hours)
Interval 0.33 to 1.0
|
0.17 (hours)
Interval 0.07 to 1.5
|
0.75 (hours)
Interval 0.17 to 2.02
|
SECONDARY outcome
Timeframe: During 12 hours after start of administrationPopulation: ITT
The terminal nicotine elimination rate constant (Lamda z)
Outcome measures
| Measure |
Oral Nicotine 1
n=40 Participants
1 administration of 1 mg
|
Oral Nicotine 2
n=40 Participants
2 administrations of 1 mg
|
Nicorette® Gum 4 mg
n=41 Participants
One marketed Nicorette® nicotine gum 4 mg chewed for 30 minutes
|
Oral Nicotine 4
n=39 Participants
4 administrations of 1 mg
|
NiQuitinTM Lozenge 4 mg
n=42 Participants
1 NiQuitinTM nicotine lozenge 4 mg
|
|---|---|---|---|---|---|
|
Terminal Elimination Rate Constant
|
0.29 (1/hr)
Standard Deviation 0.13
|
0.29 (1/hr)
Standard Deviation 0.10
|
0.31 (1/hr)
Standard Deviation 0.10
|
0.30 (1/hr)
Standard Deviation 0.10
|
0.26 (1/hr)
Standard Deviation 0.07
|
SECONDARY outcome
Timeframe: After 30 minutes' chewingPopulation: ITT
The amount of nicotine released from Nicorette® gum 4 mg during 30 minutes' chewing
Outcome measures
| Measure |
Oral Nicotine 1
n=41 Participants
1 administration of 1 mg
|
Oral Nicotine 2
2 administrations of 1 mg
|
Nicorette® Gum 4 mg
One marketed Nicorette® nicotine gum 4 mg chewed for 30 minutes
|
Oral Nicotine 4
4 administrations of 1 mg
|
NiQuitinTM Lozenge 4 mg
1 NiQuitinTM nicotine lozenge 4 mg
|
|---|---|---|---|---|---|
|
Released Nicotine
|
2.70 (ng/ml)
Standard Deviation 0.27
|
—
|
—
|
—
|
—
|
Adverse Events
Oral Nicotine 1
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Oral Nicotine 2
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Oral Nicotine 4
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
NiQuitinTM Lozenge 4 mg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Nicorette® Gum 4 mg
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Oral Nicotine 1
n=41 participants at risk
1 administration of 1 mg
|
Oral Nicotine 2
n=42 participants at risk
2 administrations of 1 mg
|
Oral Nicotine 4
n=43 participants at risk
4 administrations of 1 mg
|
NiQuitinTM Lozenge 4 mg
n=43 participants at risk
1 NiQuitinTM nicotine lozenge 4 mg
|
Nicorette® Gum 4 mg
n=42 participants at risk
One marketed Nicorette® nicotine gum 4 mg chewed for 30 minutes
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Appendicitis
|
0.00%
0/41
|
2.4%
1/42
|
0.00%
0/43
|
0.00%
0/43
|
0.00%
0/42
|
Other adverse events
| Measure |
Oral Nicotine 1
n=41 participants at risk
1 administration of 1 mg
|
Oral Nicotine 2
n=42 participants at risk
2 administrations of 1 mg
|
Oral Nicotine 4
n=43 participants at risk
4 administrations of 1 mg
|
NiQuitinTM Lozenge 4 mg
n=43 participants at risk
1 NiQuitinTM nicotine lozenge 4 mg
|
Nicorette® Gum 4 mg
n=42 participants at risk
One marketed Nicorette® nicotine gum 4 mg chewed for 30 minutes
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
4.9%
2/41
|
7.1%
3/42
|
9.3%
4/43
|
4.7%
2/43
|
4.8%
2/42
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
7.3%
3/41
|
11.9%
5/42
|
4.7%
2/43
|
2.3%
1/43
|
0.00%
0/42
|
|
Nervous system disorders
Dizziness
|
0.00%
0/41
|
2.4%
1/42
|
7.0%
3/43
|
4.7%
2/43
|
2.4%
1/42
|
|
Nervous system disorders
Headache
|
17.1%
7/41
|
2.4%
1/42
|
14.0%
6/43
|
11.6%
5/43
|
9.5%
4/42
|
|
Gastrointestinal disorders
Hiccups
|
4.9%
2/41
|
2.4%
1/42
|
23.3%
10/43
|
0.00%
0/43
|
7.1%
3/42
|
|
Gastrointestinal disorders
Throat Irritation
|
4.9%
2/41
|
9.5%
4/42
|
14.0%
6/43
|
0.00%
0/43
|
4.8%
2/42
|
Additional Information
Joyce Hauze, Sr Specialist, Clinical Research Operations
J&J Consumer and Personal Products Worldwide
Phone: 928-277-0715
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place