Trial Outcomes & Findings for Safety, Tolerability, Pharmacokinetic, and Efficacy Study of AZD5213 in Adolescents With Tourette's Disorder (NCT NCT01904773)
NCT ID: NCT01904773
Last Updated: 2016-09-23
Results Overview
Total Tic Severity Score on the the Yale Global Tic Severity Scale - Part 2 only (lower is better), range 0 - 50
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
29 participants
Primary outcome timeframe
3 week period of treatment
Results posted on
2016-09-23
Participant Flow
Subjects between the ages of 12 and 17 with Tourette's Disorder
There were 29 screening visits for 28 subjects, 1 subject was initially screen failed for exclusion 32 but rescreened and qualified and entered Part 1 of the study(104-4003 rescreened and qualified as 104-4004). Eligible subjects participated in Part 1 and then continued into a randomized 6 period crossover Part 2 of the study
Participant milestones
| Measure |
Initial Study
Initial Screen, Part 1: AZD5213 0.5 mg single dose Day 1, AZD5213 2 mg dose Days 6-8
|
Part 2 -Sequence BBABBA
B=AZD5213 0.5 mg, A=Placebo (did not tolerate 2.0 mg in Part 1)
|
Part 2- Sequence BABBAB
B=AZD5213 0.5 mg, A=Placebo (did not tolerate 2.0 mg in Part 1)
|
Part 2 - Sequence ABCACB
A=Placebo, B=AZD5213 0.5 mg, C=AZD5213 2.0 mg
|
Part 2- Sequence ACBABC
A= Placebo, B=AZD5213 0.5 mg, C=AZD5213 2.0 mg
|
Part 2- Sequence BACCAB
A=Placebo, B=AZD5213 0.5 mg, C=AZD5213 2.0 mg
|
Part 2- Sequence BCACBA
A=Placebo, B=AZD5213 0.5 mg, C=AZD5213 2.0 mg
|
Part 2 Sequence CABBAC
A=Placebo, B=AZD5213 0.5 mg, C=AZD5213 2.0 mg
|
Part 2- Seqence CBABCA
A=Placebo, B=AZD5213 0.5 mg, C=AZD5213 2.0 mg
|
|---|---|---|---|---|---|---|---|---|---|
|
Screen
STARTED
|
28
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Screen
COMPLETED
|
24
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Screen
NOT COMPLETED
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1 - Single Dose- AZD5213 0.5 mg
STARTED
|
24
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1 - Single Dose- AZD5213 0.5 mg
COMPLETED
|
24
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1 - Single Dose- AZD5213 0.5 mg
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1 - Multiple Dose AZD5213 2.0 mg
STARTED
|
24
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1 - Multiple Dose AZD5213 2.0 mg
Tolerated 2.0 mg in Part 1
|
20
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1 - Multiple Dose AZD5213 2.0 mg
Did Not Tolerate 2.0 mg in Part 1
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1 - Multiple Dose AZD5213 2.0 mg
COMPLETED
|
23
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1 - Multiple Dose AZD5213 2.0 mg
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
First Intervention
STARTED
|
0
|
2
|
1
|
2
|
3
|
4
|
4
|
3
|
4
|
|
First Intervention
COMPLETED
|
0
|
2
|
1
|
2
|
3
|
4
|
3
|
3
|
4
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Placebo Washout First Intervention
STARTED
|
0
|
2
|
1
|
2
|
3
|
4
|
3
|
3
|
4
|
|
Placebo Washout First Intervention
COMPLETED
|
0
|
1
|
1
|
2
|
3
|
4
|
3
|
3
|
4
|
|
Placebo Washout First Intervention
NOT COMPLETED
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Second Intervention
STARTED
|
0
|
1
|
1
|
2
|
3
|
4
|
3
|
3
|
4
|
|
Second Intervention
COMPLETED
|
0
|
1
|
1
|
2
|
3
|
4
|
3
|
3
|
4
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Placebo Washout Second Intervention
STARTED
|
0
|
1
|
1
|
2
|
3
|
4
|
3
|
3
|
4
|
|
Placebo Washout Second Intervention
COMPLETED
|
0
|
1
|
1
|
2
|
3
|
4
|
3
|
3
|
4
|
|
Placebo Washout Second Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Third Intervention
STARTED
|
0
|
1
|
1
|
2
|
3
|
4
|
3
|
3
|
4
|
|
Third Intervention
COMPLETED
|
0
|
1
|
1
|
2
|
3
|
4
|
3
|
3
|
4
|
|
Third Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Placebo Washout Third Intervention
STARTED
|
0
|
1
|
1
|
2
|
3
|
4
|
3
|
3
|
4
|
|
Placebo Washout Third Intervention
COMPLETED
|
0
|
1
|
1
|
2
|
3
|
4
|
3
|
3
|
4
|
|
Placebo Washout Third Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Fourth Intervention
STARTED
|
0
|
1
|
1
|
2
|
3
|
4
|
3
|
3
|
4
|
|
Fourth Intervention
COMPLETED
|
0
|
1
|
1
|
2
|
3
|
4
|
3
|
3
|
4
|
|
Fourth Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Placebo Washout Fourth Intervention
STARTED
|
0
|
1
|
1
|
2
|
3
|
4
|
3
|
3
|
4
|
|
Placebo Washout Fourth Intervention
COMPLETED
|
0
|
1
|
1
|
2
|
3
|
4
|
3
|
3
|
4
|
|
Placebo Washout Fourth Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Fifth Intervention
STARTED
|
0
|
1
|
1
|
2
|
3
|
4
|
3
|
3
|
4
|
|
Fifth Intervention
COMPLETED
|
0
|
1
|
1
|
2
|
3
|
4
|
3
|
2
|
4
|
|
Fifth Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Placebo Washout Fifth Intervention
STARTED
|
0
|
1
|
1
|
2
|
3
|
4
|
3
|
2
|
4
|
|
Placebo Washout Fifth Intervention
COMPLETED
|
0
|
0
|
1
|
2
|
3
|
4
|
3
|
2
|
4
|
|
Placebo Washout Fifth Intervention
NOT COMPLETED
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Sixth Intervention
STARTED
|
0
|
0
|
1
|
2
|
3
|
4
|
3
|
2
|
4
|
|
Sixth Intervention
COMPLETED
|
0
|
0
|
1
|
2
|
3
|
4
|
3
|
2
|
4
|
|
Sixth Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Initial Study
Initial Screen, Part 1: AZD5213 0.5 mg single dose Day 1, AZD5213 2 mg dose Days 6-8
|
Part 2 -Sequence BBABBA
B=AZD5213 0.5 mg, A=Placebo (did not tolerate 2.0 mg in Part 1)
|
Part 2- Sequence BABBAB
B=AZD5213 0.5 mg, A=Placebo (did not tolerate 2.0 mg in Part 1)
|
Part 2 - Sequence ABCACB
A=Placebo, B=AZD5213 0.5 mg, C=AZD5213 2.0 mg
|
Part 2- Sequence ACBABC
A= Placebo, B=AZD5213 0.5 mg, C=AZD5213 2.0 mg
|
Part 2- Sequence BACCAB
A=Placebo, B=AZD5213 0.5 mg, C=AZD5213 2.0 mg
|
Part 2- Sequence BCACBA
A=Placebo, B=AZD5213 0.5 mg, C=AZD5213 2.0 mg
|
Part 2 Sequence CABBAC
A=Placebo, B=AZD5213 0.5 mg, C=AZD5213 2.0 mg
|
Part 2- Seqence CBABCA
A=Placebo, B=AZD5213 0.5 mg, C=AZD5213 2.0 mg
|
|---|---|---|---|---|---|---|---|---|---|
|
Screen
Screen failure
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Screen
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1 - Multiple Dose AZD5213 2.0 mg
Adverse Event
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
First Intervention
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Placebo Washout First Intervention
Condition worsened
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Fifth Intervention
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Placebo Washout Fifth Intervention
Study specific withdrawal criteria
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Safety, Tolerability, Pharmacokinetic, and Efficacy Study of AZD5213 in Adolescents With Tourette's Disorder
Baseline characteristics by cohort
| Measure |
Overall Study
n=24 Participants
Part 1 \& Part 2
|
|---|---|
|
Age, Continuous
|
14.6 years
STANDARD_DEVIATION 1.76 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Nicotine use
Current
|
0 Participants
n=5 Participants
|
|
Nicotine use
Never
|
24 Participants
n=5 Participants
|
|
Nicotine use
Past
|
0 Participants
n=5 Participants
|
|
Tourette's Disorder Duration
|
75 months
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 week period of treatmentPopulation: All Part 2 participants
Total Tic Severity Score on the the Yale Global Tic Severity Scale - Part 2 only (lower is better), range 0 - 50
Outcome measures
| Measure |
AZD5213 0.5 mg
n=23 Participants
Part 1 single dose, Part 2 - multiple 3 week treatment periods in a randomized 6 period crossover design
|
AZD5213 2.0 mg
n=19 Participants
Part 2 - multiple 3 week treatment periods in a randomized 6 period crossover design
|
Placebo
n=21 Participants
Part 2 - multiple 3 week treatment periods in a randomized 6- period crossover design
|
|---|---|---|---|
|
Total Tic Severity Score (Part 2 Only) Crossover Analysis Over 6 Periods
|
24.32 Total Tic Severity Score
Standard Error 2.01
|
25.41 Total Tic Severity Score
Standard Error 2.05
|
22.99 Total Tic Severity Score
Standard Error 2.03
|
PRIMARY outcome
Timeframe: Day 1Population: Pharmacokinetic population
Pharmacokinetics Part 1 only: Maximum plasma Concentration (ng/ml) Single dose Day 1 AZD5213 0.5 mg
Outcome measures
| Measure |
AZD5213 0.5 mg
n=23 Participants
Part 1 single dose, Part 2 - multiple 3 week treatment periods in a randomized 6 period crossover design
|
AZD5213 2.0 mg
Part 2 - multiple 3 week treatment periods in a randomized 6 period crossover design
|
Placebo
Part 2 - multiple 3 week treatment periods in a randomized 6- period crossover design
|
|---|---|---|---|
|
Pharmacokinetics : Maximum Plasma Concentration (ng/ml) - Part 1 Only
|
3.690 Plasma concentration (ng/ml)
Standard Deviation 1.405
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1Population: Pharmacokinetic population
Pharmacokinetics Part 1 only: Time to maximum plasma concentration (hr)Single dose Day 1 AZD5213 0.5 mg
Outcome measures
| Measure |
AZD5213 0.5 mg
n=23 Participants
Part 1 single dose, Part 2 - multiple 3 week treatment periods in a randomized 6 period crossover design
|
AZD5213 2.0 mg
Part 2 - multiple 3 week treatment periods in a randomized 6 period crossover design
|
Placebo
Part 2 - multiple 3 week treatment periods in a randomized 6- period crossover design
|
|---|---|---|---|
|
Pharmacokinetics : Time to Maximum Concentration (hr) - Part 1 Only
|
2.112 Time (hr)
Standard Deviation 1.004
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1Population: Pharmacokinetic population
Pharmacokinetics Part 1 only: Single dose Day 1 AZD5213 0.5 mg Area Under the Concentration time curve (AUC) 0 to infinity (h\*ng/ml)
Outcome measures
| Measure |
AZD5213 0.5 mg
n=23 Participants
Part 1 single dose, Part 2 - multiple 3 week treatment periods in a randomized 6 period crossover design
|
AZD5213 2.0 mg
Part 2 - multiple 3 week treatment periods in a randomized 6 period crossover design
|
Placebo
Part 2 - multiple 3 week treatment periods in a randomized 6- period crossover design
|
|---|---|---|---|
|
Pharmacokinetics : AUC (h*ng/ ml) - Part 1 Only
|
26.356 AUC (h*ng/ml)
Standard Deviation 9.155
|
—
|
—
|
Adverse Events
Overall Study
Serious events: 2 serious events
Other events: 22 other events
Deaths: 0 deaths
Part 1 - AZD5213 0.5 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 1 - AZD5213 2.0 mg
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Part 2 - AZD5213 0.5 mg
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Part 2 - AZD5213 2.0 mg
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Part 2 - Placebo
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Part 1 - Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Overall Study
n=24 participants at risk
Part 1 \& Part 2
|
Part 1 - AZD5213 0.5 mg
n=24 participants at risk
Part 1 - Day 1, AZD5213 0.5 mg
|
Part 1 - AZD5213 2.0 mg
n=24 participants at risk
Part 1 - Days 6-8, AZD5213 2.0 mg
|
Part 2 - AZD5213 0.5 mg
n=23 participants at risk
Part 2 - AZD5213, 0.5 mg periods (2-4 periods)
|
Part 2 - AZD5213 2.0 mg
n=19 participants at risk
Part 2 - AZD5213, 2.0 mg periods (2 periods)
|
Part 2 - Placebo
n=21 participants at risk
Part 2 - Placebo periods (2 periods)
|
Part 1 - Placebo
n=24 participants at risk
Part 1 - Placebo, Days 2-5, washout after 0.5 mg single dose
|
|---|---|---|---|---|---|---|---|
|
Reproductive system and breast disorders
Testicular torsion (Part 2)
|
4.3%
1/23 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/23 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/19 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
4.8%
1/21 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
|
Nervous system disorders
Convulsion
|
4.2%
1/24 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
4.2%
1/24 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/23 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/19 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/21 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
Other adverse events
| Measure |
Overall Study
n=24 participants at risk
Part 1 \& Part 2
|
Part 1 - AZD5213 0.5 mg
n=24 participants at risk
Part 1 - Day 1, AZD5213 0.5 mg
|
Part 1 - AZD5213 2.0 mg
n=24 participants at risk
Part 1 - Days 6-8, AZD5213 2.0 mg
|
Part 2 - AZD5213 0.5 mg
n=23 participants at risk
Part 2 - AZD5213, 0.5 mg periods (2-4 periods)
|
Part 2 - AZD5213 2.0 mg
n=19 participants at risk
Part 2 - AZD5213, 2.0 mg periods (2 periods)
|
Part 2 - Placebo
n=21 participants at risk
Part 2 - Placebo periods (2 periods)
|
Part 1 - Placebo
n=24 participants at risk
Part 1 - Placebo, Days 2-5, washout after 0.5 mg single dose
|
|---|---|---|---|---|---|---|---|
|
Psychiatric disorders
Anxiety
|
8.3%
2/24 • Number of events 2 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/23 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
5.3%
1/19 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
4.8%
1/21 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
|
Psychiatric disorders
Confusional State
|
4.2%
1/24 • Number of events 3 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
4.2%
1/24 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/23 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
5.3%
1/19 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
4.8%
1/21 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
|
Psychiatric disorders
Initial insomnia
|
12.5%
3/24 • Number of events 4 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
4.2%
1/24 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
4.3%
1/23 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
5.3%
1/19 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/21 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
4.2%
1/24 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
|
Psychiatric disorders
Tic
|
8.3%
2/24 • Number of events 3 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/23 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
5.3%
1/19 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
4.8%
1/21 • Number of events 2 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
|
Psychiatric disorders
Abnormal behavior
|
4.2%
1/24 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/23 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/19 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
4.8%
1/21 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
|
Psychiatric disorders
Agitation
|
8.3%
2/24 • Number of events 2 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
4.2%
1/24 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
4.3%
1/23 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/19 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/21 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
|
Psychiatric disorders
Depressed mood
|
4.2%
1/24 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
4.3%
1/23 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/19 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/21 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
|
Psychiatric disorders
Impulsive behavior
|
4.2%
1/24 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
4.2%
1/24 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/23 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/19 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/21 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
|
Psychiatric disorders
Hypervigilance
|
4.2%
1/24 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
4.3%
1/23 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/19 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/21 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
|
Psychiatric disorders
Mood swings
|
4.2%
1/24 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
4.3%
1/23 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/19 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/21 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
|
Psychiatric disorders
Nightmare
|
4.2%
1/24 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/23 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
5.3%
1/19 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/21 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
|
Psychiatric disorders
Sexually inappropriate behavior
|
4.2%
1/24 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/23 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/19 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
4.8%
1/21 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
|
Psychiatric disorders
Sleep disorder
|
4.2%
1/24 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
4.3%
1/23 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/19 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/21 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
|
Nervous system disorders
Headache
|
37.5%
9/24 • Number of events 17 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
8.3%
2/24 • Number of events 2 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
21.7%
5/23 • Number of events 8 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
10.5%
2/19 • Number of events 3 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
9.5%
2/21 • Number of events 2 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
8.3%
2/24 • Number of events 2 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
|
Nervous system disorders
Dizziness
|
12.5%
3/24 • Number of events 5 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
4.2%
1/24 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
4.3%
1/23 • Number of events 2 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/19 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
4.8%
1/21 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
4.2%
1/24 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
|
Nervous system disorders
Somnolence
|
4.2%
1/24 • Number of events 2 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
4.3%
1/23 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
5.3%
1/19 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/21 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
|
Nervous system disorders
Disturbance in attention
|
4.2%
1/24 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
4.3%
1/23 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/19 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/21 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
|
Nervous system disorders
Tremor
|
4.2%
1/24 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/23 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/19 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
4.8%
1/21 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
|
Gastrointestinal disorders
Abdominal pain upper
|
12.5%
3/24 • Number of events 3 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
4.2%
1/24 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
8.7%
2/23 • Number of events 2 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/19 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/21 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
|
Gastrointestinal disorders
Dry mouth
|
8.3%
2/24 • Number of events 2 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/23 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
5.3%
1/19 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
4.8%
1/21 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
4.2%
1/24 • Number of events 2 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
4.3%
1/23 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/19 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
4.8%
1/21 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
|
Gastrointestinal disorders
Constipation
|
4.2%
1/24 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/23 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/19 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
4.8%
1/21 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
|
Gastrointestinal disorders
Diarrhoea
|
4.2%
1/24 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/23 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/19 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
4.8%
1/21 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
|
Gastrointestinal disorders
Tooth impacted
|
4.2%
1/24 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/23 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
5.3%
1/19 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/21 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
|
Gastrointestinal disorders
Vomiting
|
8.3%
2/24 • Number of events 2 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
4.2%
1/24 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
4.3%
1/23 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/19 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/21 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
4.2%
1/24 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/23 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
5.3%
1/19 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/21 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
|
Infections and infestations
Nasopharyngitis
|
25.0%
6/24 • Number of events 6 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
4.2%
1/24 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
8.7%
2/23 • Number of events 2 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
10.5%
2/19 • Number of events 2 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
4.8%
1/21 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
|
Infections and infestations
Gastroenteritis
|
4.2%
1/24 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/23 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/19 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
4.8%
1/21 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
|
Infections and infestations
Gastroenteritis viral
|
4.2%
1/24 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/23 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/19 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
4.8%
1/21 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
|
Infections and infestations
Upper respiratory tract infection
|
4.2%
1/24 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/23 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/19 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
4.8%
1/21 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
|
Infections and infestations
Viral upper respiratory tract infection
|
4.2%
1/24 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/23 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/19 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
4.8%
1/21 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
2/24 • Number of events 2 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
4.3%
1/23 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/19 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
4.8%
1/21 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.2%
1/24 • Number of events 2 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
4.3%
1/23 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/19 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
4.8%
1/21 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.2%
1/24 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
4.3%
1/23 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/19 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/21 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
4.2%
1/24 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/23 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/19 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
4.8%
1/21 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
|
Injury, poisoning and procedural complications
Chemical burn of skin
|
4.2%
1/24 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/23 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/19 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
4.8%
1/21 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
|
Injury, poisoning and procedural complications
Contusion
|
4.2%
1/24 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/23 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/19 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
4.8%
1/21 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
|
Injury, poisoning and procedural complications
Procedural pain
|
4.2%
1/24 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/23 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
5.3%
1/19 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/21 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
|
Eye disorders
Vision blurred
|
4.2%
1/24 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
4.3%
1/23 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/19 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/21 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
|
Metabolism and nutrition disorders
Decreased appetite
|
12.5%
3/24 • Number of events 3 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
4.2%
1/24 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
4.3%
1/23 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/19 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/21 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
4.2%
1/24 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
|
General disorders
Fatigue
|
8.3%
2/24 • Number of events 8 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
8.3%
2/24 • Number of events 3 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
4.3%
1/23 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
5.3%
1/19 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
4.8%
1/21 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
4.2%
1/24 • Number of events 2 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
|
General disorders
Feeling abnormal
|
8.3%
2/24 • Number of events 2 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
8.7%
2/23 • Number of events 2 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/19 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/21 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
|
General disorders
Asthenia
|
4.2%
1/24 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
4.3%
1/23 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/19 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/21 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
|
General disorders
Irritability
|
4.2%
1/24 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/23 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
5.3%
1/19 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/21 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
|
General disorders
Medical device complication
|
4.2%
1/24 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
4.3%
1/23 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/19 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/21 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
|
General disorders
Non-cardiac chest pain
|
4.2%
1/24 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
4.3%
1/23 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/19 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/21 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
|
General disorders
Pain
|
8.3%
2/24 • Number of events 2 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
4.3%
1/23 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/19 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/21 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
4.2%
1/24 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
|
General disorders
Pyrexia
|
4.2%
1/24 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
4.3%
1/23 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/19 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/21 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
|
General disorders
Thirst
|
4.2%
1/24 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
4.2%
1/24 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/23 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/19 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/21 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
|
Gastrointestinal disorders
Nausea
|
4.2%
1/24 • Number of events 2 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
4.3%
1/23 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/19 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
4.8%
1/21 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
4.2%
1/24 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/23 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
5.3%
1/19 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/21 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
|
Infections and infestations
Influenza
|
4.2%
1/24 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
4.3%
1/23 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/19 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/21 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
|
Cardiac disorders
Palpitations
|
4.2%
1/24 • Number of events 5 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
4.3%
1/23 • Number of events 2 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
5.3%
1/19 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
4.8%
1/21 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
4.2%
1/24 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
4.2%
1/24 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
4.3%
1/23 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/19 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/21 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
|
Skin and subcutaneous tissue disorders
Cold Sweats
|
4.2%
1/24 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
4.3%
1/23 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/19 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/21 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
|
Respiratory, thoracic and mediastinal disorders
Orapharangeal pain
|
8.3%
2/24 • Number of events 2 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
8.7%
2/23 • Number of events 2 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/18 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/21 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
|
Psychiatric disorders
Insomnia
|
25.0%
6/24 • Number of events 10 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
4.2%
1/24 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
12.5%
3/24 • Number of events 3 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
4.3%
1/23 • Number of events 4 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
5.3%
1/19 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
4.8%
1/21 • Number of events 1 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
0.00%
0/24 • 176 days
Part 1 - Single dose Day 1 - multiple dose day 6-8 Part 2 - Six period crossover Day 9 -176
|
Additional Information
Joel Posener, MD - Head, Early Clinical Development
AstraZeneca Pharmaceuticals LP, Neuroscience Innovative Medicines Unit
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60