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Trial Outcomes & Findings for Pharmacokinetic Study of 4 mg Nicotine Lozenge. (NCT NCT01669122)

NCT ID: NCT01669122

Last Updated: 2015-01-22

Results Overview

Area under the plasma concentration time curve from zero and extrapolated to the time of last quantifiable sample was determined from plasma concentration time profile of nicotine. AUC(0 -t) was based on the baseline adjusted nicotine plasma concentration data.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

40 participants

Primary outcome timeframe

Blood samples were collected pre-dose and at 5, 10, 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post dosing

Results posted on

2015-01-22

Participant Flow

Participants were recruited at the clinical site.

A total of 102 participants were screened, of which only 40 were randomized into the study. Fourteen participants did not meet the study criteria, 32 were lost to follow up, 2 withdrew consent while remaining 14 were not randomized due to other reasons.

Participant milestones

Participant milestones
Measure
Total Participants
Period I
STARTED
40
Period I
Safety Population
39
Period I
COMPLETED
39
Period I
NOT COMPLETED
1
Washout Period I
STARTED
39
Washout Period I
COMPLETED
39
Washout Period I
NOT COMPLETED
0
Period II
STARTED
39
Period II
COMPLETED
39
Period II
NOT COMPLETED
0
Washout Period II
STARTED
39
Washout Period II
COMPLETED
37
Washout Period II
NOT COMPLETED
2
Washout Period III
STARTED
37
Washout Period III
COMPLETED
37
Washout Period III
NOT COMPLETED
0
Period III
STARTED
37
Period III
COMPLETED
37
Period III
NOT COMPLETED
0
Period IV
STARTED
37
Period IV
COMPLETED
37
Period IV
NOT COMPLETED
0

Reasons for withdrawal

Reasons for withdrawal
Measure
Total Participants
Period I
Lost to Follow-up
1
Washout Period II
Protocol Violation
2

Baseline Characteristics

Pharmacokinetic Study of 4 mg Nicotine Lozenge.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Safety Population
n=39 Participants
Baseline measurements were performed for safety population which included all participants in the study who were dispensed at least one of the study treatment. Out of 40 randomized participants, one participant did not receive any treatment and was lost to follow-up.
Age, Continuous
28.7 Years
STANDARD_DEVIATION 6.4 • n=5 Participants
Sex: Female, Male
Female
0 Participants
n=5 Participants
Sex: Female, Male
Male
39 Participants
n=5 Participants

PRIMARY outcome

Timeframe: Blood samples were collected pre-dose and at 5, 10, 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post dosing

Population: Per protocol (PP) population: all randomized participants profiles, without a protocol deviation that would have lead to the data exclusion.

Area under the plasma concentration time curve from zero and extrapolated to the time of last quantifiable sample was determined from plasma concentration time profile of nicotine. AUC(0 -t) was based on the baseline adjusted nicotine plasma concentration data.

Outcome measures

Outcome measures
Measure
Test Lozenge (A)
n=38 Participants
4 mg nicotine lozenge with excipient A, was administered orally as a single dose treatment.
Test Lozenge (B)
n=37 Participants
4 mg nicotine lozenge with excipient B, was administered orally as a single dose treatment.
Test Lozenge (C)
n=39 Participants
4 mg nicotine lozenge with excipient C, was administered orally as a single dose treatment.
Reference Lozenge
n=38 Participants
Reference 4 mg nicotine lozenge, was administered orally as a single dose treatment.
Area Under the Curve From Time 0 to t, AUC (0-t)
89.14 nanograms (ng)*hours (h)/milliliter (mL)
Standard Deviation 44.777
87.38 nanograms (ng)*hours (h)/milliliter (mL)
Standard Deviation 42.816
86.60 nanograms (ng)*hours (h)/milliliter (mL)
Standard Deviation 36.191
91.97 nanograms (ng)*hours (h)/milliliter (mL)
Standard Deviation 45.601

PRIMARY outcome

Timeframe: Blood samples were collected pre-dose and at 5, 10, 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post dosing

Population: PP population: all randomized participants profiles, without a protocol deviation that would have lead to the data exclusion.

Maximum plasma nicotine concentration was determined from plasma-concentration time profiles. Cmax was based on the baseline adjusted nicotine plasma concentration data.

Outcome measures

Outcome measures
Measure
Test Lozenge (A)
n=38 Participants
4 mg nicotine lozenge with excipient A, was administered orally as a single dose treatment.
Test Lozenge (B)
n=37 Participants
4 mg nicotine lozenge with excipient B, was administered orally as a single dose treatment.
Test Lozenge (C)
n=39 Participants
4 mg nicotine lozenge with excipient C, was administered orally as a single dose treatment.
Reference Lozenge
n=38 Participants
Reference 4 mg nicotine lozenge, was administered orally as a single dose treatment.
Maximum Plasma Concentration (Cmax)
18.50 ng/mL
Standard Deviation 5.626
18.39 ng/mL
Standard Deviation 5.099
17.41 ng/mL
Standard Deviation 4.796
18.97 ng/mL
Standard Deviation 6.001

SECONDARY outcome

Timeframe: Blood samples were collected pre-dose and at 5, 10, 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post dosing

Population: PP population: all randomized participants profiles, without a protocol deviation that would have lead to the data exclusion.

Area under the plasma nicotine concentration-time curve from zero extrapolated to infinity was determined. AUC(0-inf) was based on the baseline adjusted nicotine plasma concentration data.

Outcome measures

Outcome measures
Measure
Test Lozenge (A)
n=38 Participants
4 mg nicotine lozenge with excipient A, was administered orally as a single dose treatment.
Test Lozenge (B)
n=37 Participants
4 mg nicotine lozenge with excipient B, was administered orally as a single dose treatment.
Test Lozenge (C)
n=39 Participants
4 mg nicotine lozenge with excipient C, was administered orally as a single dose treatment.
Reference Lozenge
n=38 Participants
Reference 4 mg nicotine lozenge, was administered orally as a single dose treatment.
AUC(0-inf)
100.33 ng*hr/mL
Standard Deviation 60.132
98.90 ng*hr/mL
Standard Deviation 61.958
97.83 ng*hr/mL
Standard Deviation 52.324
104.53 ng*hr/mL
Standard Deviation 65.525

SECONDARY outcome

Timeframe: Blood samples were collected pre-dose and at 5, 10, 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post dosing

Population: PP population: all randomized participants profiles, without a protocol deviation that would have lead to the data exclusion.

Tmax was determined from plasma concentration time profiles. Tmax was based on the baseline adjusted nicotine plasma concentration data.

Outcome measures

Outcome measures
Measure
Test Lozenge (A)
n=38 Participants
4 mg nicotine lozenge with excipient A, was administered orally as a single dose treatment.
Test Lozenge (B)
n=37 Participants
4 mg nicotine lozenge with excipient B, was administered orally as a single dose treatment.
Test Lozenge (C)
n=39 Participants
4 mg nicotine lozenge with excipient C, was administered orally as a single dose treatment.
Reference Lozenge
n=38 Participants
Reference 4 mg nicotine lozenge, was administered orally as a single dose treatment.
Time to Maximum Plasma Concentration (Tmax)
1.50 hours
Interval 0.5 to 4.0
1.50 hours
Interval 0.25 to 6.0
1.50 hours
Interval 0.75 to 6.0
1.50 hours
Interval 0.25 to 3.0

SECONDARY outcome

Timeframe: Blood samples were collected pre-dose at 5, 10, 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post dosing

Population: PP population: all randomized participants profiles, without a protocol deviation that would have lead to the data exclusion.

Elimination rate constant for nicotine was calculated. Kel was based on the baseline adjusted nicotine plasma concentration data.

Outcome measures

Outcome measures
Measure
Test Lozenge (A)
n=38 Participants
4 mg nicotine lozenge with excipient A, was administered orally as a single dose treatment.
Test Lozenge (B)
n=37 Participants
4 mg nicotine lozenge with excipient B, was administered orally as a single dose treatment.
Test Lozenge (C)
n=39 Participants
4 mg nicotine lozenge with excipient C, was administered orally as a single dose treatment.
Reference Lozenge
n=38 Participants
Reference 4 mg nicotine lozenge, was administered orally as a single dose treatment.
Rate of Elimination (Kel)
0.26 1/ hour
Standard Deviation 0.06
0.26 1/ hour
Standard Deviation 0.07
0.27 1/ hour
Standard Deviation 0.11
0.26 1/ hour
Standard Deviation 0.07

SECONDARY outcome

Timeframe: Blood samples were collected pre-dose and at 5, 10, 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post dosing

Population: PP population: all randomized participants profiles, without a protocol deviation that would have lead to the data exclusion.

Half-life of elimination of nicotine was determined. t1/2 was based on the baseline adjusted nicotine plasma concentration data.

Outcome measures

Outcome measures
Measure
Test Lozenge (A)
n=38 Participants
4 mg nicotine lozenge with excipient A, was administered orally as a single dose treatment.
Test Lozenge (B)
n=37 Participants
4 mg nicotine lozenge with excipient B, was administered orally as a single dose treatment.
Test Lozenge (C)
n=39 Participants
4 mg nicotine lozenge with excipient C, was administered orally as a single dose treatment.
Reference Lozenge
n=38 Participants
Reference 4 mg nicotine lozenge, was administered orally as a single dose treatment.
Plasma Half Life (t1/2)
2.86 hours
Standard Deviation 0.80
2.91 hours
Standard Deviation 0.99
2.86 hours
Standard Deviation 1.07
2.94 hours
Standard Deviation 0.99

Adverse Events

Test Lozenge (A)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Test Lozenge (B)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Test Lozenge (C)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Reference Lozenge

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

  • Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
  • Publication restrictions are in place

Restriction type: OTHER