Trial Outcomes & Findings for A Pharmacokinetic and Pharmacodynamic Evaluation of Cytisine in Healthy Smokers (NCT NCT03303911)
NCT ID: NCT03303911
Last Updated: 2019-10-21
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
26 participants
Primary outcome timeframe
after the first dose and the last dose on Day 1; after the last dose on Days 2, 3, 12, 16, 20, 24; and after the morning dose on Day 25
Results posted on
2019-10-21
Participant Flow
Participant milestones
| Measure |
Cytisine 1.5 mg
Multiple doses of 1.5 mg cytisine administered per 25-day schedule:
* Days 1-3 (6 times daily)
* Days 4-12 (5 times daily)
* Days 13-16 (4 times daily)
* Days 17-20 (3 times daily)
* Days 21-24 (2 times daily)
* Day 25 (Once daily)
|
Cytisine 3.0 mg
Multiple doses of 3.0 mg cytisine administered per 25-day schedule:
* Days 1-3 (6 times daily)
* Days 4-12 (5 times daily)
* Days 13-16 (4 times daily)
* Days 17-20 (3 times daily)
* Days 21-24 (2 times daily)
* Day 25 (Once daily)
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
13
|
|
Overall Study
COMPLETED
|
13
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Pharmacokinetic and Pharmacodynamic Evaluation of Cytisine in Healthy Smokers
Baseline characteristics by cohort
| Measure |
Cytisine 1.5 mg
n=13 Participants
Multiple doses of 1.5 mg cytisine administered per 25-day schedule:
* Days 1-3 (6 times daily)
* Days 4-12 (5 times daily)
* Days 13-16 (4 times daily)
* Days 17-20 (3 times daily)
* Days 21-24 (2 times daily)
* Day 25 (Once daily)
|
Cytisine 3.0 mg
n=13 Participants
Multiple doses of 3.0 mg cytisine administered per 25-day schedule:
* Days 1-3 (6 times daily)
* Days 4-12 (5 times daily)
* Days 13-16 (4 times daily)
* Days 17-20 (3 times daily)
* Days 21-24 (2 times daily)
* Day 25 (Once daily)
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Age, Continuous
|
37.0 years
STANDARD_DEVIATION 12.87 • n=93 Participants
|
40.9 years
STANDARD_DEVIATION 12.94 • n=4 Participants
|
39.0 years
STANDARD_DEVIATION 12.80 • n=27 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White
|
13 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
25 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Other, Not Specified
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Expired Carbon Monoxide (CO) at Screening
|
21.0 ppm
STANDARD_DEVIATION 8.02 • n=93 Participants
|
20.7 ppm
STANDARD_DEVIATION 6.76 • n=4 Participants
|
20.8 ppm
STANDARD_DEVIATION 7.27 • n=27 Participants
|
|
Urine Cotinine at Screening
|
1661.0 ng/mL
STANDARD_DEVIATION 502.57 • n=93 Participants
|
1944.2 ng/mL
STANDARD_DEVIATION 611.61 • n=4 Participants
|
1802.6 ng/mL
STANDARD_DEVIATION 567.13 • n=27 Participants
|
|
Number of Cigarettes Smoked in the Past 24 hours on Day -1
|
16.31 cigarettes
STANDARD_DEVIATION 3.401 • n=93 Participants
|
18.08 cigarettes
STANDARD_DEVIATION 5.171 • n=4 Participants
|
17.19 cigarettes
STANDARD_DEVIATION 4.382 • n=27 Participants
|
|
Tobacco Craving Questionnaire - Short Form (TCQ-SF) Emotionality Score at Day -1
|
10.9 score on a scale
STANDARD_DEVIATION 5.25 • n=93 Participants
|
11.7 score on a scale
STANDARD_DEVIATION 5.28 • n=4 Participants
|
11.3 score on a scale
STANDARD_DEVIATION 5.18 • n=27 Participants
|
|
TCQ-SF Expectancy Score at Day -1
|
11.4 score on a scale
STANDARD_DEVIATION 5.19 • n=93 Participants
|
14.0 score on a scale
STANDARD_DEVIATION 6.47 • n=4 Participants
|
12.7 score on a scale
STANDARD_DEVIATION 5.90 • n=27 Participants
|
|
TCQ-SF Compulsivity Score at Day -1
|
9.5 score on a scale
STANDARD_DEVIATION 4.61 • n=93 Participants
|
9.5 score on a scale
STANDARD_DEVIATION 4.33 • n=4 Participants
|
9.5 score on a scale
STANDARD_DEVIATION 4.38 • n=27 Participants
|
|
TCQ-SF Purposefulness Score at Day -1
|
14.9 score on a scale
STANDARD_DEVIATION 3.57 • n=93 Participants
|
15.6 score on a scale
STANDARD_DEVIATION 5.27 • n=4 Participants
|
15.3 score on a scale
STANDARD_DEVIATION 4.42 • n=27 Participants
|
|
TCQ-SF Total Score at Day -1
|
46.7 score on a scale
STANDARD_DEVIATION 12.96 • n=93 Participants
|
50.8 score on a scale
STANDARD_DEVIATION 16.89 • n=4 Participants
|
48.7 score on a scale
STANDARD_DEVIATION 14.90 • n=27 Participants
|
|
Fagerström Test for Nicotine Dependence Total Score at Day -1
|
4.7 score on a scale
STANDARD_DEVIATION 1.60 • n=93 Participants
|
5.3 score on a scale
STANDARD_DEVIATION 1.38 • n=4 Participants
|
5.0 score on a scale
STANDARD_DEVIATION 1.50 • n=27 Participants
|
PRIMARY outcome
Timeframe: after the first dose and the last dose on Day 1; after the last dose on Days 2, 3, 12, 16, 20, 24; and after the morning dose on Day 25Population: Pharmacokinetic (PK) Set: All randomized participants who completed all cytisine dosing on Days 1-3, completed \>90% cytisine dosing on Days 4-25 and complied with protocol-specified criteria. Participants with an assessment at given timepoint.
Outcome measures
| Measure |
Cytisine 1.5 mg
n=13 Participants
Multiple doses of 1.5 mg cytisine administered per 25-day schedule:
* Days 1-3 (6 times daily)
* Days 4-12 (5 times daily)
* Days 13-16 (4 times daily)
* Days 17-20 (3 times daily)
* Days 21-24 (2 times daily)
* Day 25 (Once daily)
|
Cytisine 3.0 mg
n=13 Participants
Multiple doses of 3.0 mg cytisine administered per 25-day schedule:
* Days 1-3 (6 times daily)
* Days 4-12 (5 times daily)
* Days 13-16 (4 times daily)
* Days 17-20 (3 times daily)
* Days 21-24 (2 times daily)
* Day 25 (Once daily)
|
|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax)
Day 3, last dose
|
35.9 ng/mL
Geometric Coefficient of Variation 21.7
|
88.1 ng/mL
Geometric Coefficient of Variation 19.3
|
|
Maximum Observed Plasma Concentration (Cmax)
Day 12, last dose
|
29.9 ng/mL
Geometric Coefficient of Variation 24.9
|
69.9 ng/mL
Geometric Coefficient of Variation 31.5
|
|
Maximum Observed Plasma Concentration (Cmax)
Day 16, last dose
|
23.7 ng/mL
Geometric Coefficient of Variation 31.4
|
50.5 ng/mL
Geometric Coefficient of Variation 26.5
|
|
Maximum Observed Plasma Concentration (Cmax)
Day 20, last dose
|
23.0 ng/mL
Geometric Coefficient of Variation 22.1
|
49.7 ng/mL
Geometric Coefficient of Variation 30.9
|
|
Maximum Observed Plasma Concentration (Cmax)
Day 24, last dose
|
16.0 ng/mL
Geometric Coefficient of Variation 28.3
|
42.0 ng/mL
Geometric Coefficient of Variation 33.6
|
|
Maximum Observed Plasma Concentration (Cmax)
Day 25
|
12.6 ng/mL
Geometric Coefficient of Variation 19.4
|
28.1 ng/mL
Geometric Coefficient of Variation 27.4
|
|
Maximum Observed Plasma Concentration (Cmax)
Day 1, first dose
|
21.1 ng/mL
Geometric Coefficient of Variation 24.8
|
40.0 ng/mL
Geometric Coefficient of Variation 26.8
|
|
Maximum Observed Plasma Concentration (Cmax)
Day 1, last dose
|
33.8 ng/mL
Geometric Coefficient of Variation 20.0
|
81.4 ng/mL
Geometric Coefficient of Variation 30.1
|
|
Maximum Observed Plasma Concentration (Cmax)
Day 2, last dose
|
32.9 ng/mL
Geometric Coefficient of Variation 22.3
|
85.1 ng/mL
Geometric Coefficient of Variation 20.9
|
PRIMARY outcome
Timeframe: after the first dose and the last dose on Day 1; after the last dose on Days 2, 3, 12, 16, 20, 24; and after the morning dose on Day 25Population: PK Set: All randomized participants who completed all cytisine dosing on Days 1-3, completed \>90% cytisine dosing on Days 4-25 and complied with protocol-specified criteria. Participants with an assessment at given time point.
Outcome measures
| Measure |
Cytisine 1.5 mg
n=13 Participants
Multiple doses of 1.5 mg cytisine administered per 25-day schedule:
* Days 1-3 (6 times daily)
* Days 4-12 (5 times daily)
* Days 13-16 (4 times daily)
* Days 17-20 (3 times daily)
* Days 21-24 (2 times daily)
* Day 25 (Once daily)
|
Cytisine 3.0 mg
n=13 Participants
Multiple doses of 3.0 mg cytisine administered per 25-day schedule:
* Days 1-3 (6 times daily)
* Days 4-12 (5 times daily)
* Days 13-16 (4 times daily)
* Days 17-20 (3 times daily)
* Days 21-24 (2 times daily)
* Day 25 (Once daily)
|
|---|---|---|
|
Time of Occurrence of Cmax (Tmax)
Day 1, first dose
|
0.500 hours
Interval 0.5 to 0.75
|
0.750 hours
Interval 0.5 to 1.0
|
|
Time of Occurrence of Cmax (Tmax)
Day 1, last dose
|
1.00 hours
Interval 0.0 to 2.5
|
1.00 hours
Interval 0.0 to 2.5
|
|
Time of Occurrence of Cmax (Tmax)
Day 2, last dose
|
1.00 hours
Interval 0.0 to 3.5
|
1.00 hours
Interval 0.0 to 3.5
|
|
Time of Occurrence of Cmax (Tmax)
Day 20, last dose
|
1.50 hours
Interval 1.0 to 5.5
|
1.00 hours
Interval 0.0 to 6.5
|
|
Time of Occurrence of Cmax (Tmax)
Day 3, last dose
|
1.00 hours
Interval 0.5 to 3.0
|
1.00 hours
Interval 0.0 to 2.03
|
|
Time of Occurrence of Cmax (Tmax)
Day 12, last dose
|
1.00 hours
Interval 0.0 to 3.05
|
1.02 hours
Interval 0.0 to 2.0
|
|
Time of Occurrence of Cmax (Tmax)
Day 16, last dose
|
2.50 hours
Interval 0.0 to 4.02
|
2.00 hours
Interval 1.0 to 6.5
|
|
Time of Occurrence of Cmax (Tmax)
Day 24, last dose
|
2.00 hours
Interval 1.0 to 4.0
|
1.00 hours
Interval 1.0 to 3.0
|
|
Time of Occurrence of Cmax (Tmax)
Day 25
|
2.50 hours
Interval 0.5 to 5.0
|
2.25 hours
Interval 0.5 to 3.75
|
PRIMARY outcome
Timeframe: after the first dose on Days 4, 13, 17, 21 and 25Population: PK Set: All randomized participants who completed all cytisine dosing on Days 1-3, completed \>90% cytisine dosing on Days 4-25 and complied with protocol-specified criteria. Participants with an assessment at given timepoint.
Outcome measures
| Measure |
Cytisine 1.5 mg
n=13 Participants
Multiple doses of 1.5 mg cytisine administered per 25-day schedule:
* Days 1-3 (6 times daily)
* Days 4-12 (5 times daily)
* Days 13-16 (4 times daily)
* Days 17-20 (3 times daily)
* Days 21-24 (2 times daily)
* Day 25 (Once daily)
|
Cytisine 3.0 mg
n=13 Participants
Multiple doses of 3.0 mg cytisine administered per 25-day schedule:
* Days 1-3 (6 times daily)
* Days 4-12 (5 times daily)
* Days 13-16 (4 times daily)
* Days 17-20 (3 times daily)
* Days 21-24 (2 times daily)
* Day 25 (Once daily)
|
|---|---|---|
|
Minimum Observed Plasma Concentration (Cmin)
Day 4, first dose
|
5.36 ng/mL
Geometric Coefficient of Variation 47.7
|
13.2 ng/mL
Geometric Coefficient of Variation 27.4
|
|
Minimum Observed Plasma Concentration (Cmin)
Day 13, first dose
|
5.16 ng/mL
Geometric Coefficient of Variation 48.2
|
12.6 ng/mL
Geometric Coefficient of Variation 33.0
|
|
Minimum Observed Plasma Concentration (Cmin)
Day 17, first dose
|
4.19 ng/mL
Geometric Coefficient of Variation 64.7
|
8.50 ng/mL
Geometric Coefficient of Variation 38.3
|
|
Minimum Observed Plasma Concentration (Cmin)
Day 21, first dose
|
3.13 ng/mL
Geometric Coefficient of Variation 83.4
|
6.34 ng/mL
Geometric Coefficient of Variation 39.0
|
|
Minimum Observed Plasma Concentration (Cmin)
Day 25
|
3.16 ng/mL
Geometric Coefficient of Variation 188.9
|
3.74 ng/mL
Geometric Coefficient of Variation 42.4
|
PRIMARY outcome
Timeframe: after the administration of the final dose of cytisine on Day 25Population: PK Set: All randomized participants who completed all cytisine dosing on Days 1-3, completed \>90% cytisine dosing on Days 4-25 and complied with protocol-specified criteria. Participants with an assessment.
Outcome measures
| Measure |
Cytisine 1.5 mg
n=12 Participants
Multiple doses of 1.5 mg cytisine administered per 25-day schedule:
* Days 1-3 (6 times daily)
* Days 4-12 (5 times daily)
* Days 13-16 (4 times daily)
* Days 17-20 (3 times daily)
* Days 21-24 (2 times daily)
* Day 25 (Once daily)
|
Cytisine 3.0 mg
n=13 Participants
Multiple doses of 3.0 mg cytisine administered per 25-day schedule:
* Days 1-3 (6 times daily)
* Days 4-12 (5 times daily)
* Days 13-16 (4 times daily)
* Days 17-20 (3 times daily)
* Days 21-24 (2 times daily)
* Day 25 (Once daily)
|
|---|---|---|
|
Area Under the Plasma Concentration Versus Time Curve (AUC) From Time Zero to the Last Sampling Time (AUC0-t)
|
67.0 h*ng/mL
Geometric Coefficient of Variation 27.4
|
185 h*ng/mL
Geometric Coefficient of Variation 32.3
|
PRIMARY outcome
Timeframe: after the administration of the final dose of cytisine on Day 25Population: PK Set: All randomized participants who completed all cytisine dosing on Days 1-3, completed \>90% cytisine dosing on Days 4-25 and complied with protocol-specified criteria. Participants with an assessment.
Outcome measures
| Measure |
Cytisine 1.5 mg
n=12 Participants
Multiple doses of 1.5 mg cytisine administered per 25-day schedule:
* Days 1-3 (6 times daily)
* Days 4-12 (5 times daily)
* Days 13-16 (4 times daily)
* Days 17-20 (3 times daily)
* Days 21-24 (2 times daily)
* Day 25 (Once daily)
|
Cytisine 3.0 mg
n=13 Participants
Multiple doses of 3.0 mg cytisine administered per 25-day schedule:
* Days 1-3 (6 times daily)
* Days 4-12 (5 times daily)
* Days 13-16 (4 times daily)
* Days 17-20 (3 times daily)
* Days 21-24 (2 times daily)
* Day 25 (Once daily)
|
|---|---|---|
|
Total AUC From Time Zero to Infinity (AUC0-∞)
|
82.6 h*ng/mL
Geometric Coefficient of Variation 30.4
|
213 h*ng/mL
Geometric Coefficient of Variation 28.0
|
PRIMARY outcome
Timeframe: after the administration of the final dose of cytisine on Day 25Population: PK Set: All randomized participants who completed all cytisine dosing on Days 1-3, completed \>90% cytisine dosing on Days 4-25 and complied with protocol-specified criteria. Participants with an assessment.
Outcome measures
| Measure |
Cytisine 1.5 mg
n=12 Participants
Multiple doses of 1.5 mg cytisine administered per 25-day schedule:
* Days 1-3 (6 times daily)
* Days 4-12 (5 times daily)
* Days 13-16 (4 times daily)
* Days 17-20 (3 times daily)
* Days 21-24 (2 times daily)
* Day 25 (Once daily)
|
Cytisine 3.0 mg
n=13 Participants
Multiple doses of 3.0 mg cytisine administered per 25-day schedule:
* Days 1-3 (6 times daily)
* Days 4-12 (5 times daily)
* Days 13-16 (4 times daily)
* Days 17-20 (3 times daily)
* Days 21-24 (2 times daily)
* Day 25 (Once daily)
|
|---|---|---|
|
Residual Area or Percentage of Extrapolated Part for the Calculation of AUC0-∞ (%AUC)
|
18.0 percentage of extrapolated part
Geometric Coefficient of Variation 28.9
|
11.7 percentage of extrapolated part
Geometric Coefficient of Variation 40.1
|
PRIMARY outcome
Timeframe: after the administration of the final dose of cytisine on Day 25Population: PK Set: All randomized participants who completed all cytisine dosing on Days 1-3, completed \>90% cytisine dosing on Days 4-25 and complied with protocol-specified criteria. Participants with an assessment.
Outcome measures
| Measure |
Cytisine 1.5 mg
n=12 Participants
Multiple doses of 1.5 mg cytisine administered per 25-day schedule:
* Days 1-3 (6 times daily)
* Days 4-12 (5 times daily)
* Days 13-16 (4 times daily)
* Days 17-20 (3 times daily)
* Days 21-24 (2 times daily)
* Day 25 (Once daily)
|
Cytisine 3.0 mg
n=13 Participants
Multiple doses of 3.0 mg cytisine administered per 25-day schedule:
* Days 1-3 (6 times daily)
* Days 4-12 (5 times daily)
* Days 13-16 (4 times daily)
* Days 17-20 (3 times daily)
* Days 21-24 (2 times daily)
* Day 25 (Once daily)
|
|---|---|---|
|
Apparent Terminal Elimination Rate Constant (λz)
|
0.185 1/hour
Geometric Coefficient of Variation 26.4
|
0.152 1/hour
Geometric Coefficient of Variation 16.9
|
PRIMARY outcome
Timeframe: after the administration of the final dose of cytisine on Day 25Population: PK Set: All randomized participants who completed all cytisine dosing on Days 1-3, completed \>90% cytisine dosing on Days 4-25 and complied with protocol-specified criteria. Participants with an assessment.
Outcome measures
| Measure |
Cytisine 1.5 mg
n=12 Participants
Multiple doses of 1.5 mg cytisine administered per 25-day schedule:
* Days 1-3 (6 times daily)
* Days 4-12 (5 times daily)
* Days 13-16 (4 times daily)
* Days 17-20 (3 times daily)
* Days 21-24 (2 times daily)
* Day 25 (Once daily)
|
Cytisine 3.0 mg
n=13 Participants
Multiple doses of 3.0 mg cytisine administered per 25-day schedule:
* Days 1-3 (6 times daily)
* Days 4-12 (5 times daily)
* Days 13-16 (4 times daily)
* Days 17-20 (3 times daily)
* Days 21-24 (2 times daily)
* Day 25 (Once daily)
|
|---|---|---|
|
Apparent Terminal Elimination Half-Life (t1/2)
|
3.75 hours
Standard Deviation 24.7
|
4.57 hours
Standard Deviation 17.2
|
PRIMARY outcome
Timeframe: Day 1 through Day 26Population: Pharmacodynamic (PD) Set: All participants in the PK set who had an available baseline result and at least 1 on-treatment result with regards to urine cotinine, expired air CO or daily cigarette consumption and did not incur a major protocol deviation. Participants with a valid assessment at given time point.
Outcome measures
| Measure |
Cytisine 1.5 mg
n=13 Participants
Multiple doses of 1.5 mg cytisine administered per 25-day schedule:
* Days 1-3 (6 times daily)
* Days 4-12 (5 times daily)
* Days 13-16 (4 times daily)
* Days 17-20 (3 times daily)
* Days 21-24 (2 times daily)
* Day 25 (Once daily)
|
Cytisine 3.0 mg
n=13 Participants
Multiple doses of 3.0 mg cytisine administered per 25-day schedule:
* Days 1-3 (6 times daily)
* Days 4-12 (5 times daily)
* Days 13-16 (4 times daily)
* Days 17-20 (3 times daily)
* Days 21-24 (2 times daily)
* Day 25 (Once daily)
|
|---|---|---|
|
Number of Cigarettes Smoked Daily During Treatment and at Day 26
Day 2
|
3.69 cigarettes smoked in the past 24 hours
Standard Deviation 1.437
|
4.08 cigarettes smoked in the past 24 hours
Standard Deviation 1.801
|
|
Number of Cigarettes Smoked Daily During Treatment and at Day 26
Day 3
|
4.00 cigarettes smoked in the past 24 hours
Standard Deviation 1.673
|
4.46 cigarettes smoked in the past 24 hours
Standard Deviation 1.854
|
|
Number of Cigarettes Smoked Daily During Treatment and at Day 26
Day -1
|
16.31 cigarettes smoked in the past 24 hours
Standard Deviation 3.401
|
18.08 cigarettes smoked in the past 24 hours
Standard Deviation 5.171
|
|
Number of Cigarettes Smoked Daily During Treatment and at Day 26
Day 1
|
7.31 cigarettes smoked in the past 24 hours
Standard Deviation 6.088
|
8.77 cigarettes smoked in the past 24 hours
Standard Deviation 6.882
|
|
Number of Cigarettes Smoked Daily During Treatment and at Day 26
Day 4
|
4.77 cigarettes smoked in the past 24 hours
Standard Deviation 2.682
|
6.15 cigarettes smoked in the past 24 hours
Standard Deviation 3.555
|
|
Number of Cigarettes Smoked Daily During Treatment and at Day 26
Day 5
|
4.08 cigarettes smoked in the past 24 hours
Standard Deviation 2.629
|
5.69 cigarettes smoked in the past 24 hours
Standard Deviation 3.568
|
|
Number of Cigarettes Smoked Daily During Treatment and at Day 26
Day 6
|
4.85 cigarettes smoked in the past 24 hours
Standard Deviation 3.826
|
7.00 cigarettes smoked in the past 24 hours
Standard Deviation 4.778
|
|
Number of Cigarettes Smoked Daily During Treatment and at Day 26
Day 7
|
4.19 cigarettes smoked in the past 24 hours
Standard Deviation 4.018
|
4.85 cigarettes smoked in the past 24 hours
Standard Deviation 4.180
|
|
Number of Cigarettes Smoked Daily During Treatment and at Day 26
Day 8
|
4.15 cigarettes smoked in the past 24 hours
Standard Deviation 3.760
|
5.38 cigarettes smoked in the past 24 hours
Standard Deviation 4.073
|
|
Number of Cigarettes Smoked Daily During Treatment and at Day 26
Day 9
|
4.77 cigarettes smoked in the past 24 hours
Standard Deviation 4.438
|
5.08 cigarettes smoked in the past 24 hours
Standard Deviation 4.555
|
|
Number of Cigarettes Smoked Daily During Treatment and at Day 26
Day 10
|
4.62 cigarettes smoked in the past 24 hours
Standard Deviation 4.234
|
4.54 cigarettes smoked in the past 24 hours
Standard Deviation 4.557
|
|
Number of Cigarettes Smoked Daily During Treatment and at Day 26
Day 11
|
3.81 cigarettes smoked in the past 24 hours
Standard Deviation 3.497
|
4.62 cigarettes smoked in the past 24 hours
Standard Deviation 4.292
|
|
Number of Cigarettes Smoked Daily During Treatment and at Day 26
Day 12
|
3.31 cigarettes smoked in the past 24 hours
Standard Deviation 3.545
|
3.69 cigarettes smoked in the past 24 hours
Standard Deviation 3.637
|
|
Number of Cigarettes Smoked Daily During Treatment and at Day 26
Day 13
|
4.15 cigarettes smoked in the past 24 hours
Standard Deviation 4.038
|
5.00 cigarettes smoked in the past 24 hours
Standard Deviation 4.163
|
|
Number of Cigarettes Smoked Daily During Treatment and at Day 26
Day 14
|
4.00 cigarettes smoked in the past 24 hours
Standard Deviation 3.786
|
3.69 cigarettes smoked in the past 24 hours
Standard Deviation 4.535
|
|
Number of Cigarettes Smoked Daily During Treatment and at Day 26
Day 15
|
4.23 cigarettes smoked in the past 24 hours
Standard Deviation 3.876
|
3.62 cigarettes smoked in the past 24 hours
Standard Deviation 4.331
|
|
Number of Cigarettes Smoked Daily During Treatment and at Day 26
Day 16
|
3.85 cigarettes smoked in the past 24 hours
Standard Deviation 3.648
|
3.08 cigarettes smoked in the past 24 hours
Standard Deviation 3.451
|
|
Number of Cigarettes Smoked Daily During Treatment and at Day 26
Day 17
|
4.00 cigarettes smoked in the past 24 hours
Standard Deviation 4.163
|
3.77 cigarettes smoked in the past 24 hours
Standard Deviation 4.781
|
|
Number of Cigarettes Smoked Daily During Treatment and at Day 26
Day 18
|
3.69 cigarettes smoked in the past 24 hours
Standard Deviation 3.903
|
3.92 cigarettes smoked in the past 24 hours
Standard Deviation 4.873
|
|
Number of Cigarettes Smoked Daily During Treatment and at Day 26
Day 19
|
3.69 cigarettes smoked in the past 24 hours
Standard Deviation 3.881
|
3.54 cigarettes smoked in the past 24 hours
Standard Deviation 4.789
|
|
Number of Cigarettes Smoked Daily During Treatment and at Day 26
Day 20
|
3.25 cigarettes smoked in the past 24 hours
Standard Deviation 3.671
|
2.58 cigarettes smoked in the past 24 hours
Standard Deviation 3.528
|
|
Number of Cigarettes Smoked Daily During Treatment and at Day 26
Day 21
|
4.54 cigarettes smoked in the past 24 hours
Standard Deviation 4.719
|
2.92 cigarettes smoked in the past 24 hours
Standard Deviation 4.462
|
|
Number of Cigarettes Smoked Daily During Treatment and at Day 26
Day 22
|
4.00 cigarettes smoked in the past 24 hours
Standard Deviation 4.163
|
3.00 cigarettes smoked in the past 24 hours
Standard Deviation 3.958
|
|
Number of Cigarettes Smoked Daily During Treatment and at Day 26
Day 23
|
4.38 cigarettes smoked in the past 24 hours
Standard Deviation 4.407
|
2.69 cigarettes smoked in the past 24 hours
Standard Deviation 4.151
|
|
Number of Cigarettes Smoked Daily During Treatment and at Day 26
Day 24
|
3.08 cigarettes smoked in the past 24 hours
Standard Deviation 2.985
|
2.38 cigarettes smoked in the past 24 hours
Standard Deviation 3.042
|
|
Number of Cigarettes Smoked Daily During Treatment and at Day 26
Day 25
|
1.17 cigarettes smoked in the past 24 hours
Standard Deviation 1.467
|
0.85 cigarettes smoked in the past 24 hours
Standard Deviation 1.214
|
|
Number of Cigarettes Smoked Daily During Treatment and at Day 26
Day 26
|
4.23 cigarettes smoked in the past 24 hours
Standard Deviation 4.206
|
3.00 cigarettes smoked in the past 24 hours
Standard Deviation 4.778
|
PRIMARY outcome
Timeframe: Baseline, Day 1 through Day 26Population: PD Set: All participants in the PK set who had an available baseline result and at least 1 on-treatment result with regards to urine cotinine, expired air CO or daily cigarette consumption and did not incur a major protocol deviation. Participants with a valid assessment at given time point.
Outcome measures
| Measure |
Cytisine 1.5 mg
n=13 Participants
Multiple doses of 1.5 mg cytisine administered per 25-day schedule:
* Days 1-3 (6 times daily)
* Days 4-12 (5 times daily)
* Days 13-16 (4 times daily)
* Days 17-20 (3 times daily)
* Days 21-24 (2 times daily)
* Day 25 (Once daily)
|
Cytisine 3.0 mg
n=13 Participants
Multiple doses of 3.0 mg cytisine administered per 25-day schedule:
* Days 1-3 (6 times daily)
* Days 4-12 (5 times daily)
* Days 13-16 (4 times daily)
* Days 17-20 (3 times daily)
* Days 21-24 (2 times daily)
* Day 25 (Once daily)
|
|---|---|---|
|
Change From Baseline in Number of Cigarettes Smoked Daily up to Day 26
Day 1
|
-9.00 cigarettes smoked in the past 24 hours
Standard Deviation 5.745
|
-9.31 cigarettes smoked in the past 24 hours
Standard Deviation 7.169
|
|
Change From Baseline in Number of Cigarettes Smoked Daily up to Day 26
Day 2
|
-12.62 cigarettes smoked in the past 24 hours
Standard Deviation 3.664
|
-14.00 cigarettes smoked in the past 24 hours
Standard Deviation 5.000
|
|
Change From Baseline in Number of Cigarettes Smoked Daily up to Day 26
Day 3
|
-11.91 cigarettes smoked in the past 24 hours
Standard Deviation 3.885
|
-13.62 cigarettes smoked in the past 24 hours
Standard Deviation 5.723
|
|
Change From Baseline in Number of Cigarettes Smoked Daily up to Day 26
Day 4
|
-11.54 cigarettes smoked in the past 24 hours
Standard Deviation 4.737
|
-11.92 cigarettes smoked in the past 24 hours
Standard Deviation 6.144
|
|
Change From Baseline in Number of Cigarettes Smoked Daily up to Day 26
Day 5
|
-12.23 cigarettes smoked in the past 24 hours
Standard Deviation 4.475
|
-12.38 cigarettes smoked in the past 24 hours
Standard Deviation 5.665
|
|
Change From Baseline in Number of Cigarettes Smoked Daily up to Day 26
Day 6
|
-11.46 cigarettes smoked in the past 24 hours
Standard Deviation 4.371
|
-11.08 cigarettes smoked in the past 24 hours
Standard Deviation 7.005
|
|
Change From Baseline in Number of Cigarettes Smoked Daily up to Day 26
Day 7
|
-12.12 cigarettes smoked in the past 24 hours
Standard Deviation 4.718
|
-13.23 cigarettes smoked in the past 24 hours
Standard Deviation 5.388
|
|
Change From Baseline in Number of Cigarettes Smoked Daily up to Day 26
Day 8
|
-12.15 cigarettes smoked in the past 24 hours
Standard Deviation 4.580
|
-12.69 cigarettes smoked in the past 24 hours
Standard Deviation 5.391
|
|
Change From Baseline in Number of Cigarettes Smoked Daily up to Day 26
Day 9
|
-11.54 cigarettes smoked in the past 24 hours
Standard Deviation 5.333
|
-13.00 cigarettes smoked in the past 24 hours
Standard Deviation 5.845
|
|
Change From Baseline in Number of Cigarettes Smoked Daily up to Day 26
Day 10
|
-11.69 cigarettes smoked in the past 24 hours
Standard Deviation 4.697
|
-13.54 cigarettes smoked in the past 24 hours
Standard Deviation 5.425
|
|
Change From Baseline in Number of Cigarettes Smoked Daily up to Day 26
Day 11
|
-12.50 cigarettes smoked in the past 24 hours
Standard Deviation 4.173
|
-13.46 cigarettes smoked in the past 24 hours
Standard Deviation 4.789
|
|
Change From Baseline in Number of Cigarettes Smoked Daily up to Day 26
Day 12
|
-13.00 cigarettes smoked in the past 24 hours
Standard Deviation 4.813
|
-14.38 cigarettes smoked in the past 24 hours
Standard Deviation 4.992
|
|
Change From Baseline in Number of Cigarettes Smoked Daily up to Day 26
Day 13
|
-12.15 cigarettes smoked in the past 24 hours
Standard Deviation 4.543
|
-13.08 cigarettes smoked in the past 24 hours
Standard Deviation 6.873
|
|
Change From Baseline in Number of Cigarettes Smoked Daily up to Day 26
Day 14
|
-12.31 cigarettes smoked in the past 24 hours
Standard Deviation 4.309
|
-14.38 cigarettes smoked in the past 24 hours
Standard Deviation 6.185
|
|
Change From Baseline in Number of Cigarettes Smoked Daily up to Day 26
Day 15
|
-12.08 cigarettes smoked in the past 24 hours
Standard Deviation 4.212
|
-14.46 cigarettes smoked in the past 24 hours
Standard Deviation 5.592
|
|
Change From Baseline in Number of Cigarettes Smoked Daily up to Day 26
Day 16
|
-12.46 cigarettes smoked in the past 24 hours
Standard Deviation 3.597
|
-15.00 cigarettes smoked in the past 24 hours
Standard Deviation 5.083
|
|
Change From Baseline in Number of Cigarettes Smoked Daily up to Day 26
Day 17
|
-12.31 cigarettes smoked in the past 24 hours
Standard Deviation 4.768
|
-14.31 cigarettes smoked in the past 24 hours
Standard Deviation 5.721
|
|
Change From Baseline in Number of Cigarettes Smoked Daily up to Day 26
Day 18
|
-12.62 cigarettes smoked in the past 24 hours
Standard Deviation 4.753
|
-14.15 cigarettes smoked in the past 24 hours
Standard Deviation 6.012
|
|
Change From Baseline in Number of Cigarettes Smoked Daily up to Day 26
Day 19
|
-12.62 cigarettes smoked in the past 24 hours
Standard Deviation 4.556
|
-14.54 cigarettes smoked in the past 24 hours
Standard Deviation 5.577
|
|
Change From Baseline in Number of Cigarettes Smoked Daily up to Day 26
Day 20
|
-13.17 cigarettes smoked in the past 24 hours
Standard Deviation 3.810
|
-15.83 cigarettes smoked in the past 24 hours
Standard Deviation 4.569
|
|
Change From Baseline in Number of Cigarettes Smoked Daily up to Day 26
Day 21
|
-11.77 cigarettes smoked in the past 24 hours
Standard Deviation 5.262
|
-15.15 cigarettes smoked in the past 24 hours
Standard Deviation 5.535
|
|
Change From Baseline in Number of Cigarettes Smoked Daily up to Day 26
Day 22
|
-12.31 cigarettes smoked in the past 24 hours
Standard Deviation 4.404
|
-15.08 cigarettes smoked in the past 24 hours
Standard Deviation 5.251
|
|
Change From Baseline in Number of Cigarettes Smoked Daily up to Day 26
Day 23
|
-11.92 cigarettes smoked in the past 24 hours
Standard Deviation 4.873
|
-15.38 cigarettes smoked in the past 24 hours
Standard Deviation 5.091
|
|
Change From Baseline in Number of Cigarettes Smoked Daily up to Day 26
Day 24
|
-13.23 cigarettes smoked in the past 24 hours
Standard Deviation 4.419
|
-15.69 cigarettes smoked in the past 24 hours
Standard Deviation 4.461
|
|
Change From Baseline in Number of Cigarettes Smoked Daily up to Day 26
Day 25
|
-14.83 cigarettes smoked in the past 24 hours
Standard Deviation 3.407
|
-17.23 cigarettes smoked in the past 24 hours
Standard Deviation 4.850
|
|
Change From Baseline in Number of Cigarettes Smoked Daily up to Day 26
Day 26
|
-12.08 cigarettes smoked in the past 24 hours
Standard Deviation 4.645
|
-15.08 cigarettes smoked in the past 24 hours
Standard Deviation 4.387
|
PRIMARY outcome
Timeframe: Baseline, Days 4, 13, 17, 21, 26Population: PD Set: All participants in the PK set who had an available baseline result and at least 1 on-treatment result with regards to urine cotinine, expired air CO or daily cigarette consumption and did not incur a major protocol deviation in a way that may have invalidated or biased the PD results.
Outcome measures
| Measure |
Cytisine 1.5 mg
n=13 Participants
Multiple doses of 1.5 mg cytisine administered per 25-day schedule:
* Days 1-3 (6 times daily)
* Days 4-12 (5 times daily)
* Days 13-16 (4 times daily)
* Days 17-20 (3 times daily)
* Days 21-24 (2 times daily)
* Day 25 (Once daily)
|
Cytisine 3.0 mg
n=13 Participants
Multiple doses of 3.0 mg cytisine administered per 25-day schedule:
* Days 1-3 (6 times daily)
* Days 4-12 (5 times daily)
* Days 13-16 (4 times daily)
* Days 17-20 (3 times daily)
* Days 21-24 (2 times daily)
* Day 25 (Once daily)
|
|---|---|---|
|
Change From Baseline in Expired Air CO up to Day 26
Day 4
|
-13.2 ppm
Standard Deviation 8.34
|
-13.8 ppm
Standard Deviation 7.03
|
|
Change From Baseline in Expired Air CO up to Day 26
Day 13
|
-15.3 ppm
Standard Deviation 8.02
|
-15.9 ppm
Standard Deviation 6.84
|
|
Change From Baseline in Expired Air CO up to Day 26
Day 17
|
-16.0 ppm
Standard Deviation 7.93
|
-16.2 ppm
Standard Deviation 5.81
|
|
Change From Baseline in Expired Air CO up to Day 26
Day 21
|
-16.4 ppm
Standard Deviation 7.79
|
-16.5 ppm
Standard Deviation 6.08
|
|
Change From Baseline in Expired Air CO up to Day 26
Day 26
|
-17.2 ppm
Standard Deviation 8.33
|
-17.9 ppm
Standard Deviation 6.75
|
PRIMARY outcome
Timeframe: Day 26Population: PD Set: All participants in the PK set who had an available baseline result and at least 1 on-treatment result with regards to urine cotinine, expired air CO or daily cigarette consumption and did not incur a major protocol deviation in a way that may have invalidated or biased the PD results.
A status of "ceased smoking" is defined as not having smoked any cigarettes for the past 24 hours on Day 26 and having an expired CO level \<10 ppm on Day 26.
Outcome measures
| Measure |
Cytisine 1.5 mg
n=13 Participants
Multiple doses of 1.5 mg cytisine administered per 25-day schedule:
* Days 1-3 (6 times daily)
* Days 4-12 (5 times daily)
* Days 13-16 (4 times daily)
* Days 17-20 (3 times daily)
* Days 21-24 (2 times daily)
* Day 25 (Once daily)
|
Cytisine 3.0 mg
n=13 Participants
Multiple doses of 3.0 mg cytisine administered per 25-day schedule:
* Days 1-3 (6 times daily)
* Days 4-12 (5 times daily)
* Days 13-16 (4 times daily)
* Days 17-20 (3 times daily)
* Days 21-24 (2 times daily)
* Day 25 (Once daily)
|
|---|---|---|
|
Number of Participants Who Ceased or Continued Smoking on Day 26
Ceased Smoking
|
5 Participants
|
7 Participants
|
|
Number of Participants Who Ceased or Continued Smoking on Day 26
Continued Smoking
|
8 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: Baseline, Days 4, 13, 17, 21, 26Population: PD Set: All participants in the PK set who had an available baseline result and at least 1 on-treatment result with regards to urine cotinine, expired air CO or daily cigarette consumption and did not incur a major protocol deviation in a way that may have invalidated or biased the PD results.
Outcome measures
| Measure |
Cytisine 1.5 mg
n=13 Participants
Multiple doses of 1.5 mg cytisine administered per 25-day schedule:
* Days 1-3 (6 times daily)
* Days 4-12 (5 times daily)
* Days 13-16 (4 times daily)
* Days 17-20 (3 times daily)
* Days 21-24 (2 times daily)
* Day 25 (Once daily)
|
Cytisine 3.0 mg
n=13 Participants
Multiple doses of 3.0 mg cytisine administered per 25-day schedule:
* Days 1-3 (6 times daily)
* Days 4-12 (5 times daily)
* Days 13-16 (4 times daily)
* Days 17-20 (3 times daily)
* Days 21-24 (2 times daily)
* Day 25 (Once daily)
|
|---|---|---|
|
Change From Baseline Over Time in Urine Cotinine
Day 17
|
-1012.1 ng/mL
Standard Deviation 710.39
|
-1405.2 ng/mL
Standard Deviation 814.08
|
|
Change From Baseline Over Time in Urine Cotinine
Day 21
|
-1095.1 ng/mL
Standard Deviation 679.81
|
-1446.3 ng/mL
Standard Deviation 828.68
|
|
Change From Baseline Over Time in Urine Cotinine
Day 4
|
-1040.8 ng/mL
Standard Deviation 579.78
|
-1339.2 ng/mL
Standard Deviation 550.74
|
|
Change From Baseline Over Time in Urine Cotinine
Day 13
|
-1010.0 ng/mL
Standard Deviation 797.78
|
-1309.3 ng/mL
Standard Deviation 761.77
|
|
Change From Baseline Over Time in Urine Cotinine
Day 26
|
-1362.2 ng/mL
Standard Deviation 545.84
|
-1640.2 ng/mL
Standard Deviation 688.84
|
PRIMARY outcome
Timeframe: Baseline (Day -1), Days 4, 13, 17, 21, 26Population: PD Set: All participants in the PK set who had an available baseline result and at least 1 on-treatment result with regards to urine cotinine, expired air CO or daily cigarette consumption and did not incur a major protocol deviation in a way that may have invalidated or biased the PD results.
The TCQ-SF is a 12-item questionnaire that assesses 4 components of tobacco craving: emotionality (3 items), expectancy (3 items), compulsivity (3 items) and purposefulness (3 items). Responses to each item are scored from 1 (strongly disagree) through 7 (strongly disagree). Component scores are defined as the sum of the scores within each component. The total score is defined as the sum of the 4 component scores. Emotionality scores may range from 3 to 21, with lower scores indicating weaker emotional signs of tobacco craving.
Outcome measures
| Measure |
Cytisine 1.5 mg
n=13 Participants
Multiple doses of 1.5 mg cytisine administered per 25-day schedule:
* Days 1-3 (6 times daily)
* Days 4-12 (5 times daily)
* Days 13-16 (4 times daily)
* Days 17-20 (3 times daily)
* Days 21-24 (2 times daily)
* Day 25 (Once daily)
|
Cytisine 3.0 mg
n=13 Participants
Multiple doses of 3.0 mg cytisine administered per 25-day schedule:
* Days 1-3 (6 times daily)
* Days 4-12 (5 times daily)
* Days 13-16 (4 times daily)
* Days 17-20 (3 times daily)
* Days 21-24 (2 times daily)
* Day 25 (Once daily)
|
|---|---|---|
|
Change From Baseline Over Time in TCQ-SF Score: Emotionality
Day 4
|
-5.2 score on a scale
Standard Deviation 5.40
|
-6.0 score on a scale
Standard Deviation 5.03
|
|
Change From Baseline Over Time in TCQ-SF Score: Emotionality
Day 13
|
-4.9 score on a scale
Standard Deviation 5.96
|
-7.2 score on a scale
Standard Deviation 4.88
|
|
Change From Baseline Over Time in TCQ-SF Score: Emotionality
Day 17
|
-5.8 score on a scale
Standard Deviation 6.12
|
-7.3 score on a scale
Standard Deviation 5.06
|
|
Change From Baseline Over Time in TCQ-SF Score: Emotionality
Day 21
|
-5.8 score on a scale
Standard Deviation 6.38
|
-7.6 score on a scale
Standard Deviation 5.09
|
|
Change From Baseline Over Time in TCQ-SF Score: Emotionality
Day 26
|
-5.7 score on a scale
Standard Deviation 7.00
|
-8.2 score on a scale
Standard Deviation 4.98
|
PRIMARY outcome
Timeframe: Baseline (Day -1), Days 4, 13, 17, 21, 26Population: PD Set: All participants in the PK set who had an available baseline result and at least 1 on-treatment result with regards to urine cotinine, expired air CO or daily cigarette consumption and did not incur a major protocol deviation in a way that may have invalidated or biased the PD results. Participants with an assessment at given time point.
The TCQ-SF is a 12-item questionnaire that assesses 4 components of tobacco craving: emotionality (3 items), expectancy (3 items), compulsivity (3 items) and purposefulness (3 items). Responses to each item are scored from 1 (strongly disagree) through 7 (strongly disagree). Component scores are defined as the sum of the scores within each component. The total score is defined as the sum of the 4 component scores. Expectancy scores may range from 3 to 21, with lower scores indicating less positive expectations about smoking.
Outcome measures
| Measure |
Cytisine 1.5 mg
n=13 Participants
Multiple doses of 1.5 mg cytisine administered per 25-day schedule:
* Days 1-3 (6 times daily)
* Days 4-12 (5 times daily)
* Days 13-16 (4 times daily)
* Days 17-20 (3 times daily)
* Days 21-24 (2 times daily)
* Day 25 (Once daily)
|
Cytisine 3.0 mg
n=13 Participants
Multiple doses of 3.0 mg cytisine administered per 25-day schedule:
* Days 1-3 (6 times daily)
* Days 4-12 (5 times daily)
* Days 13-16 (4 times daily)
* Days 17-20 (3 times daily)
* Days 21-24 (2 times daily)
* Day 25 (Once daily)
|
|---|---|---|
|
Change From Baseline Over Time in TCQ-SF Score: Expectancy
Day 4
|
-3.8 score on a scale
Standard Deviation 5.89
|
-8.0 score on a scale
Standard Deviation 6.00
|
|
Change From Baseline Over Time in TCQ-SF Score: Expectancy
Day 13
|
-3.5 score on a scale
Standard Deviation 7.83
|
-8.4 score on a scale
Standard Deviation 5.91
|
|
Change From Baseline Over Time in TCQ-SF Score: Expectancy
Day 17
|
-4.7 score on a scale
Standard Deviation 6.96
|
-8.8 score on a scale
Standard Deviation 5.82
|
|
Change From Baseline Over Time in TCQ-SF Score: Expectancy
Day 21
|
-5.2 score on a scale
Standard Deviation 6.56
|
-9.2 score on a scale
Standard Deviation 5.75
|
|
Change From Baseline Over Time in TCQ-SF Score: Expectancy
Day 26
|
-6.2 score on a scale
Standard Deviation 6.40
|
-9.8 score on a scale
Standard Deviation 6.15
|
PRIMARY outcome
Timeframe: Baseline (Day -1), Days 4, 13, 17, 21, 26Population: PD Set: All participants in the PK set who had an available baseline result and at least 1 on-treatment result with regards to urine cotinine, expired air CO or daily cigarette consumption and did not incur a major protocol deviation in a way that may have invalidated or biased the PD results.
The TCQ-SF is a 12-item questionnaire that assesses 4 components of tobacco craving: emotionality (3 items), expectancy (3 items), compulsivity (3 items) and purposefulness (3 items). Responses to each item are scored from 1 (strongly disagree) through 7 (strongly agree). Component scores are defined as the sum of the scores within each component. The total score is defined as the sum of the 4 component scores. Compulsivity scores may range from 3 to 21, with lower scores indicating compulsion to smoke was a lesser component of tobacco craving.
Outcome measures
| Measure |
Cytisine 1.5 mg
n=13 Participants
Multiple doses of 1.5 mg cytisine administered per 25-day schedule:
* Days 1-3 (6 times daily)
* Days 4-12 (5 times daily)
* Days 13-16 (4 times daily)
* Days 17-20 (3 times daily)
* Days 21-24 (2 times daily)
* Day 25 (Once daily)
|
Cytisine 3.0 mg
n=13 Participants
Multiple doses of 3.0 mg cytisine administered per 25-day schedule:
* Days 1-3 (6 times daily)
* Days 4-12 (5 times daily)
* Days 13-16 (4 times daily)
* Days 17-20 (3 times daily)
* Days 21-24 (2 times daily)
* Day 25 (Once daily)
|
|---|---|---|
|
Change From Baseline Over Time in TCQ-SF Score: Compulsivity
Day 4
|
-3.2 score on a scale
Standard Deviation 3.18
|
-3.5 score on a scale
Standard Deviation 4.74
|
|
Change From Baseline Over Time in TCQ-SF Score: Compulsivity
Day 13
|
-3.7 score on a scale
Standard Deviation 6.56
|
-4.9 score on a scale
Standard Deviation 4.77
|
|
Change From Baseline Over Time in TCQ-SF Score: Compulsivity
Day 17
|
-4.4 score on a scale
Standard Deviation 6.32
|
-5.2 score on a scale
Standard Deviation 4.44
|
|
Change From Baseline Over Time in TCQ-SF Score: Compulsivity
Day 21
|
-4.4 score on a scale
Standard Deviation 5.49
|
-5.3 score on a scale
Standard Deviation 4.82
|
|
Change From Baseline Over Time in TCQ-SF Score: Compulsivity
Day 26
|
-4.3 score on a scale
Standard Deviation 5.94
|
-5.8 score on a scale
Standard Deviation 4.59
|
PRIMARY outcome
Timeframe: Baseline (Day -1), Days 4, 13, 17, 21, 26Population: PD Set: All participants in the PK set who had an available baseline result and at least 1 on-treatment result with regards to urine cotinine, expired air CO or daily cigarette consumption and did not incur a major protocol deviation in a way that may have invalidated or biased the PD results.
The TCQ-SF is a 12-item questionnaire that assesses 4 components of tobacco craving: emotionality (3 items), expectancy (3 items), compulsivity (3 items) and purposefulness (3 items). Responses to each item are scored from 1 (strongly disagree) through 7 (strongly disagree). Component scores are defined as the sum of the scores within each component. The total score is defined as the sum of the 4 component scores. Purposefulness scores may range from 3 to 21, with lower scores indicating stronger ability to not smoke.
Outcome measures
| Measure |
Cytisine 1.5 mg
n=13 Participants
Multiple doses of 1.5 mg cytisine administered per 25-day schedule:
* Days 1-3 (6 times daily)
* Days 4-12 (5 times daily)
* Days 13-16 (4 times daily)
* Days 17-20 (3 times daily)
* Days 21-24 (2 times daily)
* Day 25 (Once daily)
|
Cytisine 3.0 mg
n=13 Participants
Multiple doses of 3.0 mg cytisine administered per 25-day schedule:
* Days 1-3 (6 times daily)
* Days 4-12 (5 times daily)
* Days 13-16 (4 times daily)
* Days 17-20 (3 times daily)
* Days 21-24 (2 times daily)
* Day 25 (Once daily)
|
|---|---|---|
|
Change From Baseline Over Time in TCQ-SF Score: Purposefulness
Day 4
|
-6.5 score on a scale
Standard Deviation 2.93
|
-7.5 score on a scale
Standard Deviation 4.99
|
|
Change From Baseline Over Time in TCQ-SF Score: Purposefulness
Day 13
|
-6.6 score on a scale
Standard Deviation 6.34
|
-9.1 score on a scale
Standard Deviation 5.45
|
|
Change From Baseline Over Time in TCQ-SF Score: Purposefulness
Day 17
|
-7.6 score on a scale
Standard Deviation 6.33
|
-9.2 score on a scale
Standard Deviation 6.09
|
|
Change From Baseline Over Time in TCQ-SF Score: Purposefulness
Day 21
|
-7.8 score on a scale
Standard Deviation 6.48
|
-10.3 score on a scale
Standard Deviation 5.65
|
|
Change From Baseline Over Time in TCQ-SF Score: Purposefulness
Day 26
|
-9.0 score on a scale
Standard Deviation 5.15
|
-11.1 score on a scale
Standard Deviation 5.54
|
PRIMARY outcome
Timeframe: Baseline (Day -1), Days 4, 13, 17, 21, 26Population: PD Set: All participants in the PK set who had an available baseline result and at least 1 on-treatment result with regards to urine cotinine, expired air CO or daily cigarette consumption and did not incur a major protocol deviation in a way that may have invalidated or biased the PD results. Participants with an assessment at given time point.
The TCQ-SF is a 12-item questionnaire that assesses 4 components of tobacco craving: emotionality (3 items), expectancy (3 items), compulsivity (3 items) and purposefulness (3 items). Responses to each item are scored from 1 (strongly disagree) through 7 (strongly disagree). Component scores are defined as the sum of the scores within each component. The total score is defined as the sum of the 4 component scores. Total scores may range from 12 to 84, with lower scores indicating lower tobacco craving.
Outcome measures
| Measure |
Cytisine 1.5 mg
n=13 Participants
Multiple doses of 1.5 mg cytisine administered per 25-day schedule:
* Days 1-3 (6 times daily)
* Days 4-12 (5 times daily)
* Days 13-16 (4 times daily)
* Days 17-20 (3 times daily)
* Days 21-24 (2 times daily)
* Day 25 (Once daily)
|
Cytisine 3.0 mg
n=13 Participants
Multiple doses of 3.0 mg cytisine administered per 25-day schedule:
* Days 1-3 (6 times daily)
* Days 4-12 (5 times daily)
* Days 13-16 (4 times daily)
* Days 17-20 (3 times daily)
* Days 21-24 (2 times daily)
* Day 25 (Once daily)
|
|---|---|---|
|
Change From Baseline Over Time in TCQ-SF Score: Total Score
Day 17
|
-22.5 score on a scale
Standard Deviation 22.17
|
-30.5 score on a scale
Standard Deviation 16.51
|
|
Change From Baseline Over Time in TCQ-SF Score: Total Score
Day 4
|
-18.7 score on a scale
Standard Deviation 12.88
|
-26.0 score on a scale
Standard Deviation 16.06
|
|
Change From Baseline Over Time in TCQ-SF Score: Total Score
Day 13
|
-18.7 score on a scale
Standard Deviation 22.11
|
-29.6 score on a scale
Standard Deviation 16.58
|
|
Change From Baseline Over Time in TCQ-SF Score: Total Score
Day 21
|
-23.2 score on a scale
Standard Deviation 21.79
|
-32.5 score on a scale
Standard Deviation 16.62
|
|
Change From Baseline Over Time in TCQ-SF Score: Total Score
Day 26
|
-25.2 score on a scale
Standard Deviation 20.55
|
-34.8 score on a scale
Standard Deviation 16.85
|
SECONDARY outcome
Timeframe: Day 1 (6 times daily at 2-hour intervals); after the administration of the single dose of cytisine on Day 25Population: PK Set: All randomized subjects who completed all cytisine dosing on Days 1-3, completed \>90% cytisine dosing on Days 4-25 and complied with protocol-specified criteria.
Outcome measures
| Measure |
Cytisine 1.5 mg
n=13 Participants
Multiple doses of 1.5 mg cytisine administered per 25-day schedule:
* Days 1-3 (6 times daily)
* Days 4-12 (5 times daily)
* Days 13-16 (4 times daily)
* Days 17-20 (3 times daily)
* Days 21-24 (2 times daily)
* Day 25 (Once daily)
|
Cytisine 3.0 mg
n=13 Participants
Multiple doses of 3.0 mg cytisine administered per 25-day schedule:
* Days 1-3 (6 times daily)
* Days 4-12 (5 times daily)
* Days 13-16 (4 times daily)
* Days 17-20 (3 times daily)
* Days 21-24 (2 times daily)
* Day 25 (Once daily)
|
|---|---|---|
|
Cytisine Amount Excreted in Urine Over Time (Ae0-24h)
Day 1
|
7.95 mg
Geometric Coefficient of Variation 14.3
|
16.5 mg
Geometric Coefficient of Variation 12.0
|
|
Cytisine Amount Excreted in Urine Over Time (Ae0-24h)
Day 25
|
1.54 mg
Geometric Coefficient of Variation 17.4
|
3.14 mg
Geometric Coefficient of Variation 12.6
|
SECONDARY outcome
Timeframe: Day 1 (6 times daily at 2-hour intervals); after the administration of the single dose of cytisine on Day 25Population: PK Set: All randomized subjects who completed all cytisine dosing on Days 1-3, completed \>90% cytisine dosing on Days 4-25 and complied with protocol-specified criteria.
Outcome measures
| Measure |
Cytisine 1.5 mg
n=13 Participants
Multiple doses of 1.5 mg cytisine administered per 25-day schedule:
* Days 1-3 (6 times daily)
* Days 4-12 (5 times daily)
* Days 13-16 (4 times daily)
* Days 17-20 (3 times daily)
* Days 21-24 (2 times daily)
* Day 25 (Once daily)
|
Cytisine 3.0 mg
n=13 Participants
Multiple doses of 3.0 mg cytisine administered per 25-day schedule:
* Days 1-3 (6 times daily)
* Days 4-12 (5 times daily)
* Days 13-16 (4 times daily)
* Days 17-20 (3 times daily)
* Days 21-24 (2 times daily)
* Day 25 (Once daily)
|
|---|---|---|
|
Percent of Drug Excreted in Urine (Ae%)
Day 1
|
88.3 percentage of excreted drug
Geometric Coefficient of Variation 14.3
|
91.6 percentage of excreted drug
Geometric Coefficient of Variation 12.0
|
|
Percent of Drug Excreted in Urine (Ae%)
Day 25
|
102 percentage of excreted drug
Geometric Coefficient of Variation 17.4
|
105 percentage of excreted drug
Geometric Coefficient of Variation 12.5
|
SECONDARY outcome
Timeframe: From first dose of study drug through Day 26 plus 6-8 daysPopulation: Safety Set: all randomized participants who received at least one dose of cytisine.
An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with the treatment. A serious adverse event (SAE) is defined as an AE that results in any of the following: results in death; is life-threatening; requires hospitalisation or prolongs existing inpatient's hospitalisation; results in persistent or significant disability or incapacity; results in a congenital abnormality or birth defect; is an important medical event which requires medical intervention to prevent any of the above outcomes.TEAEs are defined as AEs not present prior to first administration of investigational product, or AEs present before first administration of investigational product that worsen after the participant receives the first dose of investigational product.
Outcome measures
| Measure |
Cytisine 1.5 mg
n=13 Participants
Multiple doses of 1.5 mg cytisine administered per 25-day schedule:
* Days 1-3 (6 times daily)
* Days 4-12 (5 times daily)
* Days 13-16 (4 times daily)
* Days 17-20 (3 times daily)
* Days 21-24 (2 times daily)
* Day 25 (Once daily)
|
Cytisine 3.0 mg
n=13 Participants
Multiple doses of 3.0 mg cytisine administered per 25-day schedule:
* Days 1-3 (6 times daily)
* Days 4-12 (5 times daily)
* Days 13-16 (4 times daily)
* Days 17-20 (3 times daily)
* Days 21-24 (2 times daily)
* Day 25 (Once daily)
|
|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, and Discontinuation of Study Drug Due to TEAEs
TEAEs
|
9 Participants
|
9 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, and Discontinuation of Study Drug Due to TEAEs
Serious TEAEs
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, and Discontinuation of Study Drug Due to TEAEs
Discontinuation of Study Drug due to TEAE
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: up to Day 26Population: Safety Set: all randomized participants who received at least one dose of cytisine.
Outcome measures
| Measure |
Cytisine 1.5 mg
n=13 Participants
Multiple doses of 1.5 mg cytisine administered per 25-day schedule:
* Days 1-3 (6 times daily)
* Days 4-12 (5 times daily)
* Days 13-16 (4 times daily)
* Days 17-20 (3 times daily)
* Days 21-24 (2 times daily)
* Day 25 (Once daily)
|
Cytisine 3.0 mg
n=13 Participants
Multiple doses of 3.0 mg cytisine administered per 25-day schedule:
* Days 1-3 (6 times daily)
* Days 4-12 (5 times daily)
* Days 13-16 (4 times daily)
* Days 17-20 (3 times daily)
* Days 21-24 (2 times daily)
* Day 25 (Once daily)
|
|---|---|---|
|
Number of Participants With Clinically Significant Values in Biochemistry, Hematology, and Urinalysis
Biochemistry
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Values in Biochemistry, Hematology, and Urinalysis
Hematology
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Values in Biochemistry, Hematology, and Urinalysis
Urinalysis
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: up to Day 26Population: Safety Set: all randomized participants who received at least one dose of cytisine.
Outcome measures
| Measure |
Cytisine 1.5 mg
n=13 Participants
Multiple doses of 1.5 mg cytisine administered per 25-day schedule:
* Days 1-3 (6 times daily)
* Days 4-12 (5 times daily)
* Days 13-16 (4 times daily)
* Days 17-20 (3 times daily)
* Days 21-24 (2 times daily)
* Day 25 (Once daily)
|
Cytisine 3.0 mg
n=13 Participants
Multiple doses of 3.0 mg cytisine administered per 25-day schedule:
* Days 1-3 (6 times daily)
* Days 4-12 (5 times daily)
* Days 13-16 (4 times daily)
* Days 17-20 (3 times daily)
* Days 21-24 (2 times daily)
* Day 25 (Once daily)
|
|---|---|---|
|
Number of Participants With Clinically Significant Values in Vital Signs and Physical Examinations
Vital Signs
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Values in Vital Signs and Physical Examinations
Physical Examinations
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: up to Day 26Population: ECG Set: all participants who received at least 1 dose of cytisine, with at least 1 available baseline ECG and at least 1 on-treatment ECG.
Outcome measures
| Measure |
Cytisine 1.5 mg
n=13 Participants
Multiple doses of 1.5 mg cytisine administered per 25-day schedule:
* Days 1-3 (6 times daily)
* Days 4-12 (5 times daily)
* Days 13-16 (4 times daily)
* Days 17-20 (3 times daily)
* Days 21-24 (2 times daily)
* Day 25 (Once daily)
|
Cytisine 3.0 mg
n=13 Participants
Multiple doses of 3.0 mg cytisine administered per 25-day schedule:
* Days 1-3 (6 times daily)
* Days 4-12 (5 times daily)
* Days 13-16 (4 times daily)
* Days 17-20 (3 times daily)
* Days 21-24 (2 times daily)
* Day 25 (Once daily)
|
|---|---|---|
|
Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Parameters
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: on Day 1 and Day 25 at 30 and 15 minutes prior to the first dose and 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours post dosePopulation: ECG Set: all participants who received at least 1 dose of cytisine, with at least 1 available baseline ECG and at least 1 on-treatment ECG.
Based on the mean of the triplicate recordings at each time point. Increase (↑)/decrease (↓) calculated from Baseline (BL), defined as the mean of all recordings taken prior to dosing on Day 1 (i.e. -30 minutes and -15 minutes). A participant with multiple occurrences of an event is counted only once per event.
Outcome measures
| Measure |
Cytisine 1.5 mg
n=13 Participants
Multiple doses of 1.5 mg cytisine administered per 25-day schedule:
* Days 1-3 (6 times daily)
* Days 4-12 (5 times daily)
* Days 13-16 (4 times daily)
* Days 17-20 (3 times daily)
* Days 21-24 (2 times daily)
* Day 25 (Once daily)
|
Cytisine 3.0 mg
n=13 Participants
Multiple doses of 3.0 mg cytisine administered per 25-day schedule:
* Days 1-3 (6 times daily)
* Days 4-12 (5 times daily)
* Days 13-16 (4 times daily)
* Days 17-20 (3 times daily)
* Days 21-24 (2 times daily)
* Day 25 (Once daily)
|
|---|---|---|
|
Number of Participants With Holter ECG Outlier Values
Day 1: Heart Rate >100 bpm & ↑ ≥25%
|
1 Participants
|
0 Participants
|
|
Number of Participants With Holter ECG Outlier Values
Day 1: PR Interval >200 mSec & ↑ ≥25%
|
0 Participants
|
0 Participants
|
|
Number of Participants With Holter ECG Outlier Values
Day 1: QT Interval >500 mSec & BL ≤500 mSec
|
0 Participants
|
0 Participants
|
|
Number of Participants With Holter ECG Outlier Values
Day 25: QTcF Interval >500 mSec & BL ≤500 mSec
|
0 Participants
|
0 Participants
|
|
Number of Participants With Holter ECG Outlier Values
Day 1: Heart Rate <50 bpm & ↓ ≥ 25%
|
0 Participants
|
0 Participants
|
|
Number of Participants With Holter ECG Outlier Values
Day 1: QRS Duration >100 mSec & ↑ ≥25%
|
0 Participants
|
0 Participants
|
|
Number of Participants With Holter ECG Outlier Values
Day 1: QTcF Interval >500 mSec & BL ≤500 mSec
|
0 Participants
|
0 Participants
|
|
Number of Participants With Holter ECG Outlier Values
Day 1: QTcF Interval >480 mSec & BL ≤480 mSec
|
0 Participants
|
0 Participants
|
|
Number of Participants With Holter ECG Outlier Values
Day 1: QTcF Interval >450 mSec & BL ≤450 mSec
|
0 Participants
|
1 Participants
|
|
Number of Participants With Holter ECG Outlier Values
Day 25: Heart Rate <50 bpm & ↓ ≥ 25%
|
0 Participants
|
0 Participants
|
|
Number of Participants With Holter ECG Outlier Values
Day 25: Heart Rate >100 bpm & ↑ ≥25%
|
1 Participants
|
0 Participants
|
|
Number of Participants With Holter ECG Outlier Values
Day 25: PR Interval >200 mSec & ↑ ≥25%
|
0 Participants
|
0 Participants
|
|
Number of Participants With Holter ECG Outlier Values
Day 25: QRS Duration >100 mSec & ↑ ≥25%
|
0 Participants
|
1 Participants
|
|
Number of Participants With Holter ECG Outlier Values
Day 25: QT Interval >500 mSec & BL ≤500 mSec
|
0 Participants
|
0 Participants
|
|
Number of Participants With Holter ECG Outlier Values
Day 25: QTcF Interval >480 mSec & BL ≤480 mSec
|
0 Participants
|
0 Participants
|
|
Number of Participants With Holter ECG Outlier Values
Day 25: QTcF Interval >450 mSec & BL ≤450 mSec
|
0 Participants
|
0 Participants
|
Adverse Events
Cytisine 1.5 mg
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Cytisine 3.0 mg
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cytisine 1.5 mg
n=13 participants at risk
Multiple doses of 1.5 mg cytisine administered per 25-day schedule:
* Days 1-3 (6 times daily)
* Days 4-12 (5 times daily)
* Days 13-16 (4 times daily)
* Days 17-20 (3 times daily)
* Days 21-24 (2 times daily)
* Day 25 (Once daily)
|
Cytisine 3.0 mg
n=13 participants at risk
Multiple doses of 3.0 mg cytisine administered per 25-day schedule:
* Days 1-3 (6 times daily)
* Days 4-12 (5 times daily)
* Days 13-16 (4 times daily)
* Days 17-20 (3 times daily)
* Days 21-24 (2 times daily)
* Day 25 (Once daily)
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/13 • From first dose of study drug through Day 26 plus 6-8 days
TEAEs are presented. TEAEs are defined as AEs not present prior to first administration of investigational product, or AEs present before first administration of investigational product that worsen after the participant receives the first dose of investigational product.
|
7.7%
1/13 • From first dose of study drug through Day 26 plus 6-8 days
TEAEs are presented. TEAEs are defined as AEs not present prior to first administration of investigational product, or AEs present before first administration of investigational product that worsen after the participant receives the first dose of investigational product.
|
|
Gastrointestinal disorders
Constipation
|
7.7%
1/13 • From first dose of study drug through Day 26 plus 6-8 days
TEAEs are presented. TEAEs are defined as AEs not present prior to first administration of investigational product, or AEs present before first administration of investigational product that worsen after the participant receives the first dose of investigational product.
|
7.7%
1/13 • From first dose of study drug through Day 26 plus 6-8 days
TEAEs are presented. TEAEs are defined as AEs not present prior to first administration of investigational product, or AEs present before first administration of investigational product that worsen after the participant receives the first dose of investigational product.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/13 • From first dose of study drug through Day 26 plus 6-8 days
TEAEs are presented. TEAEs are defined as AEs not present prior to first administration of investigational product, or AEs present before first administration of investigational product that worsen after the participant receives the first dose of investigational product.
|
7.7%
1/13 • From first dose of study drug through Day 26 plus 6-8 days
TEAEs are presented. TEAEs are defined as AEs not present prior to first administration of investigational product, or AEs present before first administration of investigational product that worsen after the participant receives the first dose of investigational product.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/13 • From first dose of study drug through Day 26 plus 6-8 days
TEAEs are presented. TEAEs are defined as AEs not present prior to first administration of investigational product, or AEs present before first administration of investigational product that worsen after the participant receives the first dose of investigational product.
|
7.7%
1/13 • From first dose of study drug through Day 26 plus 6-8 days
TEAEs are presented. TEAEs are defined as AEs not present prior to first administration of investigational product, or AEs present before first administration of investigational product that worsen after the participant receives the first dose of investigational product.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/13 • From first dose of study drug through Day 26 plus 6-8 days
TEAEs are presented. TEAEs are defined as AEs not present prior to first administration of investigational product, or AEs present before first administration of investigational product that worsen after the participant receives the first dose of investigational product.
|
15.4%
2/13 • From first dose of study drug through Day 26 plus 6-8 days
TEAEs are presented. TEAEs are defined as AEs not present prior to first administration of investigational product, or AEs present before first administration of investigational product that worsen after the participant receives the first dose of investigational product.
|
|
Gastrointestinal disorders
Tooth loss
|
7.7%
1/13 • From first dose of study drug through Day 26 plus 6-8 days
TEAEs are presented. TEAEs are defined as AEs not present prior to first administration of investigational product, or AEs present before first administration of investigational product that worsen after the participant receives the first dose of investigational product.
|
0.00%
0/13 • From first dose of study drug through Day 26 plus 6-8 days
TEAEs are presented. TEAEs are defined as AEs not present prior to first administration of investigational product, or AEs present before first administration of investigational product that worsen after the participant receives the first dose of investigational product.
|
|
Gastrointestinal disorders
Toothache
|
7.7%
1/13 • From first dose of study drug through Day 26 plus 6-8 days
TEAEs are presented. TEAEs are defined as AEs not present prior to first administration of investigational product, or AEs present before first administration of investigational product that worsen after the participant receives the first dose of investigational product.
|
7.7%
1/13 • From first dose of study drug through Day 26 plus 6-8 days
TEAEs are presented. TEAEs are defined as AEs not present prior to first administration of investigational product, or AEs present before first administration of investigational product that worsen after the participant receives the first dose of investigational product.
|
|
General disorders
Chest discomfort
|
0.00%
0/13 • From first dose of study drug through Day 26 plus 6-8 days
TEAEs are presented. TEAEs are defined as AEs not present prior to first administration of investigational product, or AEs present before first administration of investigational product that worsen after the participant receives the first dose of investigational product.
|
7.7%
1/13 • From first dose of study drug through Day 26 plus 6-8 days
TEAEs are presented. TEAEs are defined as AEs not present prior to first administration of investigational product, or AEs present before first administration of investigational product that worsen after the participant receives the first dose of investigational product.
|
|
General disorders
Medical device site reaction
|
7.7%
1/13 • From first dose of study drug through Day 26 plus 6-8 days
TEAEs are presented. TEAEs are defined as AEs not present prior to first administration of investigational product, or AEs present before first administration of investigational product that worsen after the participant receives the first dose of investigational product.
|
7.7%
1/13 • From first dose of study drug through Day 26 plus 6-8 days
TEAEs are presented. TEAEs are defined as AEs not present prior to first administration of investigational product, or AEs present before first administration of investigational product that worsen after the participant receives the first dose of investigational product.
|
|
General disorders
Peripheral swelling
|
0.00%
0/13 • From first dose of study drug through Day 26 plus 6-8 days
TEAEs are presented. TEAEs are defined as AEs not present prior to first administration of investigational product, or AEs present before first administration of investigational product that worsen after the participant receives the first dose of investigational product.
|
7.7%
1/13 • From first dose of study drug through Day 26 plus 6-8 days
TEAEs are presented. TEAEs are defined as AEs not present prior to first administration of investigational product, or AEs present before first administration of investigational product that worsen after the participant receives the first dose of investigational product.
|
|
Infections and infestations
Rhinitis
|
7.7%
1/13 • From first dose of study drug through Day 26 plus 6-8 days
TEAEs are presented. TEAEs are defined as AEs not present prior to first administration of investigational product, or AEs present before first administration of investigational product that worsen after the participant receives the first dose of investigational product.
|
0.00%
0/13 • From first dose of study drug through Day 26 plus 6-8 days
TEAEs are presented. TEAEs are defined as AEs not present prior to first administration of investigational product, or AEs present before first administration of investigational product that worsen after the participant receives the first dose of investigational product.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
7.7%
1/13 • From first dose of study drug through Day 26 plus 6-8 days
TEAEs are presented. TEAEs are defined as AEs not present prior to first administration of investigational product, or AEs present before first administration of investigational product that worsen after the participant receives the first dose of investigational product.
|
0.00%
0/13 • From first dose of study drug through Day 26 plus 6-8 days
TEAEs are presented. TEAEs are defined as AEs not present prior to first administration of investigational product, or AEs present before first administration of investigational product that worsen after the participant receives the first dose of investigational product.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
7.7%
1/13 • From first dose of study drug through Day 26 plus 6-8 days
TEAEs are presented. TEAEs are defined as AEs not present prior to first administration of investigational product, or AEs present before first administration of investigational product that worsen after the participant receives the first dose of investigational product.
|
0.00%
0/13 • From first dose of study drug through Day 26 plus 6-8 days
TEAEs are presented. TEAEs are defined as AEs not present prior to first administration of investigational product, or AEs present before first administration of investigational product that worsen after the participant receives the first dose of investigational product.
|
|
Nervous system disorders
Headache
|
30.8%
4/13 • From first dose of study drug through Day 26 plus 6-8 days
TEAEs are presented. TEAEs are defined as AEs not present prior to first administration of investigational product, or AEs present before first administration of investigational product that worsen after the participant receives the first dose of investigational product.
|
46.2%
6/13 • From first dose of study drug through Day 26 plus 6-8 days
TEAEs are presented. TEAEs are defined as AEs not present prior to first administration of investigational product, or AEs present before first administration of investigational product that worsen after the participant receives the first dose of investigational product.
|
|
Nervous system disorders
Vision blurred
|
0.00%
0/13 • From first dose of study drug through Day 26 plus 6-8 days
TEAEs are presented. TEAEs are defined as AEs not present prior to first administration of investigational product, or AEs present before first administration of investigational product that worsen after the participant receives the first dose of investigational product.
|
7.7%
1/13 • From first dose of study drug through Day 26 plus 6-8 days
TEAEs are presented. TEAEs are defined as AEs not present prior to first administration of investigational product, or AEs present before first administration of investigational product that worsen after the participant receives the first dose of investigational product.
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/13 • From first dose of study drug through Day 26 plus 6-8 days
TEAEs are presented. TEAEs are defined as AEs not present prior to first administration of investigational product, or AEs present before first administration of investigational product that worsen after the participant receives the first dose of investigational product.
|
7.7%
1/13 • From first dose of study drug through Day 26 plus 6-8 days
TEAEs are presented. TEAEs are defined as AEs not present prior to first administration of investigational product, or AEs present before first administration of investigational product that worsen after the participant receives the first dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.7%
1/13 • From first dose of study drug through Day 26 plus 6-8 days
TEAEs are presented. TEAEs are defined as AEs not present prior to first administration of investigational product, or AEs present before first administration of investigational product that worsen after the participant receives the first dose of investigational product.
|
0.00%
0/13 • From first dose of study drug through Day 26 plus 6-8 days
TEAEs are presented. TEAEs are defined as AEs not present prior to first administration of investigational product, or AEs present before first administration of investigational product that worsen after the participant receives the first dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Sinonasal obstruction
|
7.7%
1/13 • From first dose of study drug through Day 26 plus 6-8 days
TEAEs are presented. TEAEs are defined as AEs not present prior to first administration of investigational product, or AEs present before first administration of investigational product that worsen after the participant receives the first dose of investigational product.
|
0.00%
0/13 • From first dose of study drug through Day 26 plus 6-8 days
TEAEs are presented. TEAEs are defined as AEs not present prior to first administration of investigational product, or AEs present before first administration of investigational product that worsen after the participant receives the first dose of investigational product.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
7.7%
1/13 • From first dose of study drug through Day 26 plus 6-8 days
TEAEs are presented. TEAEs are defined as AEs not present prior to first administration of investigational product, or AEs present before first administration of investigational product that worsen after the participant receives the first dose of investigational product.
|
0.00%
0/13 • From first dose of study drug through Day 26 plus 6-8 days
TEAEs are presented. TEAEs are defined as AEs not present prior to first administration of investigational product, or AEs present before first administration of investigational product that worsen after the participant receives the first dose of investigational product.
|
Additional Information
Daniel Cain, Vice President, Clinical Research
Achieve Life Sciences
Phone: 425.686.1546
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Principal Investigators are bound by requirements outlined in their individual clinical trial agreements with regard to publication of trial results.
- Publication restrictions are in place
Restriction type: OTHER