Trial Outcomes & Findings for Safety, Tolerability,Pharmacokinetics and Pharmacodynamics of ODM-106 in Healthy Volunteers (NCT NCT02393950)
NCT ID: NCT02393950
Last Updated: 2016-12-23
Results Overview
Clinically relevant changes from baseline in safety laboratory assessments (haematology, clinical chemistry, urinalysis), vital signs (pulse and heart rate), 12 lead electrocardiograms, Holter electrocardiograms, telemetry, physical examination.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
16 participants
Primary outcome timeframe
From screening up to 16 weeks
Results posted on
2016-12-23
Participant Flow
Healthy male volunteers were recruited
Screening : Male subjects were screened and following PE, vital signs, EEG, ECG and lab. assessments were randomised into the study. Sixteen subjects were randomised to 2 panels of 8, each subject received 3 single doses of ODM-106 and 1 dose of placebo in a randomised crossover design. Panel 1 was completed before Panel 2 commenced dosing.
Participant milestones
| Measure |
Panel 1
Single oral doses ODM-106 Capsule B: 2, 10, 25, 50 mg , placebo
|
Panel 2
Single oral doses ODM-106 Capsule B: 100, 100, 200mg. ODM-106 Capsule A 100 mg , placebo
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
9
|
|
Overall Study
Period 1
|
8
|
8
|
|
Overall Study
Period 2
|
8
|
8
|
|
Overall Study
Period 3
|
8
|
8
|
|
Overall Study
Period 4
|
8
|
8
|
|
Overall Study
COMPLETED
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Panel 1
Single oral doses ODM-106 Capsule B: 2, 10, 25, 50 mg , placebo
|
Panel 2
Single oral doses ODM-106 Capsule B: 100, 100, 200mg. ODM-106 Capsule A 100 mg , placebo
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Safety, Tolerability,Pharmacokinetics and Pharmacodynamics of ODM-106 in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
Panel 1
n=9 Participants
Single oral doses ODM-106 Capsule B 2, 10, 25, 50mg, placebo
|
Panel 2
n=9 Participants
Single oral doses ODM-106 Capsule B 100, 100, 200 mg. ODM-106 Capsule A 100mg, placebo
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Gender
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Gender
Male
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
9 participants
n=5 Participants
|
9 participants
n=7 Participants
|
18 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From screening up to 16 weeksClinically relevant changes from baseline in safety laboratory assessments (haematology, clinical chemistry, urinalysis), vital signs (pulse and heart rate), 12 lead electrocardiograms, Holter electrocardiograms, telemetry, physical examination.
Outcome measures
| Measure |
ODM-106 Capsule B 2mg
n=6 Participants
Single oral dose 2 x 1 mg ODM-106 Capsule B
|
ODM-106 Capsule B 10mg
n=6 Participants
Single oral dose 2 x 5 mg ODM-106 Capsule B
|
ODM-106 Capsule B 25mg
n=6 Participants
Single oral dose 2 x 10mg 1 x 5 mg ODM-106 Capsule B
|
ODM-106 Capsule B 50mg
n=6 Participants
Single oral dose 5 x 10mg ODM-106 Capsule B
|
ODM-106 Capsule B 100mg (1 x 100mg)
n=6 Participants
Single oral dose 1 x 100mg ODM-106 Capsule B
|
ODM-106 Capsule B 100mg (10 x 10mg)
n=6 Participants
Single oral dose 10 x 10mg ODM-106 Capsule B
|
ODM-106 Capsule B 200mg
n=6 Participants
Single oral dose 20 x 10mg ODM-106 Capsule B
|
ODM-106 Capsule A 100mg
n=6 Participants
Single oral dose 10 x 10mg ODM-106 Capsule A
|
Placebo
n=16 Participants
2 placebo subjects per Arm with matched number of placebo capsules.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events as a Measure of Safety. Number of Participants With Adverse Events Related to Tolerability.
|
0 subjects affected
|
4 subjects affected
|
5 subjects affected
|
1 subjects affected
|
2 subjects affected
|
1 subjects affected
|
3 subjects affected
|
2 subjects affected
|
3 subjects affected
|
SECONDARY outcome
Timeframe: Pre-dose and 15, 30 and 45 min, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose at each dose level.cMax of ODM-106 after single dosing of either Capsule B or Capsule A
Outcome measures
| Measure |
ODM-106 Capsule B 2mg
n=6 Participants
Single oral dose 2 x 1 mg ODM-106 Capsule B
|
ODM-106 Capsule B 10mg
n=6 Participants
Single oral dose 2 x 5 mg ODM-106 Capsule B
|
ODM-106 Capsule B 25mg
n=6 Participants
Single oral dose 2 x 10mg 1 x 5 mg ODM-106 Capsule B
|
ODM-106 Capsule B 50mg
n=6 Participants
Single oral dose 5 x 10mg ODM-106 Capsule B
|
ODM-106 Capsule B 100mg (1 x 100mg)
n=6 Participants
Single oral dose 1 x 100mg ODM-106 Capsule B
|
ODM-106 Capsule B 100mg (10 x 10mg)
n=6 Participants
Single oral dose 10 x 10mg ODM-106 Capsule B
|
ODM-106 Capsule B 200mg
n=6 Participants
Single oral dose 20 x 10mg ODM-106 Capsule B
|
ODM-106 Capsule A 100mg
n=6 Participants
Single oral dose 10 x 10mg ODM-106 Capsule A
|
Placebo
2 placebo subjects per Arm with matched number of placebo capsules.
|
|---|---|---|---|---|---|---|---|---|---|
|
Peak Plasma Concentration (cMax) of ODM-106
|
9.1 ng/ml
Standard Deviation 4.2
|
18.4 ng/ml
Standard Deviation 11.4
|
67.8 ng/ml
Standard Deviation 51.7
|
119.2 ng/ml
Standard Deviation 60.1
|
22.0 ng/ml
Standard Deviation 20.1
|
225.9 ng/ml
Standard Deviation 177.2
|
547.7 ng/ml
Standard Deviation 319.5
|
8.3 ng/ml
Standard Deviation 9.1
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 15, 30 and 45 min, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose at each dose level. Urine sampling, pre-dose and for 24 hours post dose at each dose levelAUC of ODM-106 after single oral dosing of either Capsule B or Capsule A.
Outcome measures
| Measure |
ODM-106 Capsule B 2mg
n=6 Participants
Single oral dose 2 x 1 mg ODM-106 Capsule B
|
ODM-106 Capsule B 10mg
n=6 Participants
Single oral dose 2 x 5 mg ODM-106 Capsule B
|
ODM-106 Capsule B 25mg
n=6 Participants
Single oral dose 2 x 10mg 1 x 5 mg ODM-106 Capsule B
|
ODM-106 Capsule B 50mg
n=6 Participants
Single oral dose 5 x 10mg ODM-106 Capsule B
|
ODM-106 Capsule B 100mg (1 x 100mg)
n=6 Participants
Single oral dose 1 x 100mg ODM-106 Capsule B
|
ODM-106 Capsule B 100mg (10 x 10mg)
n=6 Participants
Single oral dose 10 x 10mg ODM-106 Capsule B
|
ODM-106 Capsule B 200mg
n=6 Participants
Single oral dose 20 x 10mg ODM-106 Capsule B
|
ODM-106 Capsule A 100mg
n=6 Participants
Single oral dose 10 x 10mg ODM-106 Capsule A
|
Placebo
2 placebo subjects per Arm with matched number of placebo capsules.
|
|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration Versus Time Curve (AUC) of ODM-106
|
16.9 h*ng/ml
Standard Deviation 8.8
|
61.3 h*ng/ml
Standard Deviation 44.1
|
213.8 h*ng/ml
Standard Deviation 78.7
|
559.4 h*ng/ml
Standard Deviation 310.9
|
297.4 h*ng/ml
Standard Deviation 346.3
|
1089.2 h*ng/ml
Standard Deviation 977.0
|
2850.8 h*ng/ml
Standard Deviation 2319.8
|
82.0 h*ng/ml
Standard Deviation 64.7
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 15, 30 and 45 min, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose at each dose leveltmax of ODM-106 after single oral dosing of Capsule B or Capsule A
Outcome measures
| Measure |
ODM-106 Capsule B 2mg
n=6 Participants
Single oral dose 2 x 1 mg ODM-106 Capsule B
|
ODM-106 Capsule B 10mg
n=6 Participants
Single oral dose 2 x 5 mg ODM-106 Capsule B
|
ODM-106 Capsule B 25mg
n=6 Participants
Single oral dose 2 x 10mg 1 x 5 mg ODM-106 Capsule B
|
ODM-106 Capsule B 50mg
n=6 Participants
Single oral dose 5 x 10mg ODM-106 Capsule B
|
ODM-106 Capsule B 100mg (1 x 100mg)
n=6 Participants
Single oral dose 1 x 100mg ODM-106 Capsule B
|
ODM-106 Capsule B 100mg (10 x 10mg)
n=6 Participants
Single oral dose 10 x 10mg ODM-106 Capsule B
|
ODM-106 Capsule B 200mg
n=6 Participants
Single oral dose 20 x 10mg ODM-106 Capsule B
|
ODM-106 Capsule A 100mg
n=6 Participants
Single oral dose 10 x 10mg ODM-106 Capsule A
|
Placebo
2 placebo subjects per Arm with matched number of placebo capsules.
|
|---|---|---|---|---|---|---|---|---|---|
|
Time to Peak Plasma Concentration (Tmax) of ODM-106
|
0.7 h
Interval 0.5 to 1.0
|
1.9 h
Interval 1.5 to 3.0
|
1.5 h
Interval 0.5 to 3.0
|
2.1 h
Interval 0.8 to 3.5
|
5.8 h
Interval 1.5 to 23.9
|
1.5 h
Interval 0.8 to 3.5
|
1.5 h
Interval 0.8 to 3.5
|
3.0 h
Interval 1.5 to 4.0
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 15, 30 and 45 min, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose at each dose level.Elimination half-life of ODM-106 after single dosing of either Capsule B or Capsule A
Outcome measures
| Measure |
ODM-106 Capsule B 2mg
n=6 Participants
Single oral dose 2 x 1 mg ODM-106 Capsule B
|
ODM-106 Capsule B 10mg
n=6 Participants
Single oral dose 2 x 5 mg ODM-106 Capsule B
|
ODM-106 Capsule B 25mg
n=6 Participants
Single oral dose 2 x 10mg 1 x 5 mg ODM-106 Capsule B
|
ODM-106 Capsule B 50mg
n=6 Participants
Single oral dose 5 x 10mg ODM-106 Capsule B
|
ODM-106 Capsule B 100mg (1 x 100mg)
n=6 Participants
Single oral dose 1 x 100mg ODM-106 Capsule B
|
ODM-106 Capsule B 100mg (10 x 10mg)
n=6 Participants
Single oral dose 10 x 10mg ODM-106 Capsule B
|
ODM-106 Capsule B 200mg
n=6 Participants
Single oral dose 20 x 10mg ODM-106 Capsule B
|
ODM-106 Capsule A 100mg
n=6 Participants
Single oral dose 10 x 10mg ODM-106 Capsule A
|
Placebo
2 placebo subjects per Arm with matched number of placebo capsules.
|
|---|---|---|---|---|---|---|---|---|---|
|
Elimination Half-life of ODM-106
|
9.5 h
Standard Deviation 5.5
|
20.6 h
Standard Deviation 12.7
|
23.0 h
Standard Deviation 2.1
|
27.3 h
Standard Deviation 4.7
|
23.5 h
Standard Deviation 6.3
|
27.4 h
Standard Deviation 9.2
|
32.1 h
Standard Deviation 10.0
|
21.7 h
Standard Deviation 3.2
|
—
|
SECONDARY outcome
Timeframe: Plasma samples at pre-dose and 15, 30 and 45 min, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose at each dose level. Urine samples, pre-dose and for 24 hours post dose at each dose levelMetabolite screening in plasma and urine after single dosing
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Predose and 1, 2, 3,4, 6 and 8 hours post dose at each dose level.Population: Only timepoints 2 - 6h evaluated.
Growth hormone levels (Cmax) in serum after single oral dosing with either ODM-106 Capsule B, ODM-106 Capsule A or placebo.
Outcome measures
| Measure |
ODM-106 Capsule B 2mg
n=5 Participants
Single oral dose 2 x 1 mg ODM-106 Capsule B
|
ODM-106 Capsule B 10mg
n=5 Participants
Single oral dose 2 x 5 mg ODM-106 Capsule B
|
ODM-106 Capsule B 25mg
n=6 Participants
Single oral dose 2 x 10mg 1 x 5 mg ODM-106 Capsule B
|
ODM-106 Capsule B 50mg
n=5 Participants
Single oral dose 5 x 10mg ODM-106 Capsule B
|
ODM-106 Capsule B 100mg (1 x 100mg)
n=6 Participants
Single oral dose 1 x 100mg ODM-106 Capsule B
|
ODM-106 Capsule B 100mg (10 x 10mg)
n=6 Participants
Single oral dose 10 x 10mg ODM-106 Capsule B
|
ODM-106 Capsule B 200mg
n=6 Participants
Single oral dose 20 x 10mg ODM-106 Capsule B
|
ODM-106 Capsule A 100mg
n=6 Participants
Single oral dose 10 x 10mg ODM-106 Capsule A
|
Placebo
n=14 Participants
2 placebo subjects per Arm with matched number of placebo capsules.
|
|---|---|---|---|---|---|---|---|---|---|
|
Effect of ODM-106 on Growth Hormone Levels
|
1.7 ng/ml
Standard Deviation 3.2
|
0.47 ng/ml
Standard Deviation 1.04
|
1.05 ng/ml
Standard Deviation 2.88
|
1.93 ng/ml
Standard Deviation 1.99
|
0.8 ng/ml
Standard Deviation 1.36
|
2.23 ng/ml
Standard Deviation 6.12
|
0.82 ng/ml
Standard Deviation 0.68
|
4.14 ng/ml
Standard Deviation 4.96
|
1.01 ng/ml
Standard Deviation 2.45
|
SECONDARY outcome
Timeframe: Pre-dose and at 1, 6 and 10.5h post dose at each dose levelAssessment of sedation by subject
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose and at 1 and 6h post dose at each dose levelSelected battery of psychomotor tests
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose and at 1, 6 and 10 h post dose at each dose levelQuantitative analysis of EEG
Outcome measures
Outcome data not reported
Adverse Events
ODM-106 Capsule B 2mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
ODM-106 Capsule B 10mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
ODM-106 Capsule B 25mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
ODM-106 Capsule B 50mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
ODM-106 Capsule B 100mg (1 x 100mg)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
ODM-106 Capsule B 100mg (10 x 10mg)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
ODM-106 Capsule B 200mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
ODM-106 Capsule A 100mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ODM-106 Capsule B 2mg
n=6 participants at risk
Single oral dose 2 x 1 mg ODM-106 Capsule B
|
ODM-106 Capsule B 10mg
n=6 participants at risk
Single oral dose 2 x 5 mg ODM-106 Capsule B
|
ODM-106 Capsule B 25mg
n=6 participants at risk
Single oral dose 2 x 10 mg 1 x 5 mg ODM-106 Capsule B
|
ODM-106 Capsule B 50mg
n=6 participants at risk
Single oral dose 5 x 10 mg ODM-106 Capsule B
|
ODM-106 Capsule B 100mg (1 x 100mg)
n=6 participants at risk
Single oral dose 1 x 100 mg ODM-106 Capsule B
|
ODM-106 Capsule B 100mg (10 x 10mg)
n=6 participants at risk
Single oral dose 10 x 10 mg ODM-106 Capsule B
|
ODM-106 Capsule B 200mg
n=6 participants at risk
Single oral dose 20 x 10 mg ODM-106 Capsule B
|
ODM-106 Capsule A 100mg
n=6 participants at risk
Single oral dose 10 x 10 mg ODM-106 Capsule A
|
Placebo
n=16 participants at risk
2 placebo subjects per Arm with matched number of placebo capsules
|
|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
GASTROENTERITIS
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
16.7%
1/6 • Number of events 1 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/16 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
|
Injury, poisoning and procedural complications
SUNBURN
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
16.7%
1/6 • Number of events 1 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/16 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
|
Cardiac disorders
RHYTHM IDIOVENTRICULAR
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
16.7%
1/6 • Number of events 1 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/16 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
|
Cardiac disorders
VENTRICULAR EXTRASYSTOLES
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
16.7%
1/6 • Number of events 1 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/16 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
16.7%
1/6 • Number of events 1 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
16.7%
1/6 • Number of events 1 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/16 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL DRYNESS
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
16.7%
1/6 • Number of events 1 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
16.7%
1/6 • Number of events 1 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/16 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
16.7%
1/6 • Number of events 1 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
16.7%
1/6 • Number of events 1 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/16 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
|
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
16.7%
1/6 • Number of events 1 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/16 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
|
Nervous system disorders
DISTURBANCE IN ATTENTION
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
16.7%
1/6 • Number of events 1 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/16 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
|
Nervous system disorders
DYSGEUSIA
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
6.2%
1/16 • Number of events 1 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
|
Nervous system disorders
HEADACHE
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
16.7%
1/6 • Number of events 1 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
66.7%
4/6 • Number of events 4 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
6.2%
1/16 • Number of events 1 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
|
Ear and labyrinth disorders
EAR DISCOMFORT
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
16.7%
1/6 • Number of events 1 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/16 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
6.2%
1/16 • Number of events 1 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
|
Gastrointestinal disorders
NAUSEA
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
16.7%
1/6 • Number of events 1 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/16 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
|
Skin and subcutaneous tissue disorders
HYPERHIDROSIS
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
16.7%
1/6 • Number of events 1 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/16 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
16.7%
1/6 • Number of events 1 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/16 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
16.7%
1/6 • Number of events 1 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
16.7%
1/6 • Number of events 1 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/16 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
|
Infections and infestations
ABCESS LIMB
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
16.7%
1/6 • Number of events 1 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/16 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
|
Infections and infestations
NASAL HERPES
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
16.7%
1/6 • Number of events 1 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/16 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
|
Infections and infestations
NASOPHARYNGITIS
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
16.7%
1/6 • Number of events 1 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
16.7%
1/6 • Number of events 1 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
50.0%
3/6 • Number of events 3 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/16 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
|
Infections and infestations
RHINITIS
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
16.7%
1/6 • Number of events 1 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/16 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
16.7%
1/6 • Number of events 1 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/6 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
0.00%
0/16 • From the start of study treatment until the end of study visit (approximately 12-16 weeks)
16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place