Trial Outcomes & Findings for Safety, Tolerability and Pharmacokinetic Study of Multiple Rising Doses of TAK- 063 in Participants With Stable Schizophrenia and Healthy Participants (NCT NCT01879722)
NCT ID: NCT01879722
Last Updated: 2016-10-28
Results Overview
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
77 participants
Primary outcome timeframe
Day 1 to Day 14
Results posted on
2016-10-28
Participant Flow
Participants took part in the study at 1 investigative site in the United States from 21 June 2013 (First participant signed consent) to 23 June 2014.
Participants with a diagnosis of Schizophrenia were enrolled into 1 of 6 treatment groups, once a day placebo, 3 mg, 10 mg, 20 mg, 30 mg or 100 mg TAK-063. Healthy Japanese participants were enrolled in 1 of 4 treatment groups, once a day placebo, 3 mg, 10 mg or 20 mg TAK-063.
Participant milestones
| Measure |
TAK-063 3 mg (Schizophrenia Participants)
TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 10 mg (Schizophrenia Participants)
TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 20 mg (Schizophrenia Participants)
TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 30 mg (Schizophrenia Participants)
TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 100 mg (Schizophrenia Participants)
TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
Placebo (Schizophrenia Participants)
Placebo matching TAK-063, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 3 mg (Healthy Participants)
TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
|
TAK-063 10 mg (Healthy Participants)
TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
|
TAK-063 20 mg (Healthy Participants)
TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
|
Placebo (Healthy Participants)
Placebo matching TAK-063, tablets, orally, once daily for 7 days in healthy Japanese participants.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
8
|
7
|
8
|
8
|
9
|
8
|
8
|
8
|
6
|
|
Overall Study
COMPLETED
|
7
|
7
|
7
|
7
|
7
|
9
|
8
|
7
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
1
|
1
|
0
|
0
|
1
|
2
|
0
|
Reasons for withdrawal
| Measure |
TAK-063 3 mg (Schizophrenia Participants)
TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 10 mg (Schizophrenia Participants)
TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 20 mg (Schizophrenia Participants)
TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 30 mg (Schizophrenia Participants)
TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 100 mg (Schizophrenia Participants)
TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
Placebo (Schizophrenia Participants)
Placebo matching TAK-063, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 3 mg (Healthy Participants)
TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
|
TAK-063 10 mg (Healthy Participants)
TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
|
TAK-063 20 mg (Healthy Participants)
TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
|
Placebo (Healthy Participants)
Placebo matching TAK-063, tablets, orally, once daily for 7 days in healthy Japanese participants.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Pretreatment Event/Adverse Event
|
0
|
1
|
0
|
1
|
1
|
0
|
0
|
1
|
1
|
0
|
|
Overall Study
Voluntary Withdrawal
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Safety, Tolerability and Pharmacokinetic Study of Multiple Rising Doses of TAK- 063 in Participants With Stable Schizophrenia and Healthy Participants
Baseline characteristics by cohort
| Measure |
TAK-063 3 mg (Schizophrenia Participants)
n=7 Participants
TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia
|
TAK-063 10 mg (Schizophrenia Participants)
n=8 Participants
TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 20 mg (Schizophrenia Participants)
n=7 Participants
TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 30 mg (Schizophrenia Participants)
n=8 Participants
TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 100 mg (Schizophrenia Participants)
n=8 Participants
TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
Placebo (Schizophrenia Participants)
n=9 Participants
Placebo matching TAK-063, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 3 mg (Healthy Participants)
n=8 Participants
TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
|
TAK-063 10 mg (Healthy Participants)
n=8 Participants
TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
|
TAK-063 20 mg (Healthy Participants)
n=8 Participants
TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
|
Placebo (Healthy Participants)
n=6 Participants
Placebo matching TAK-063, tablets, orally, once daily for 7 days in healthy Japanese participants.
|
Total
n=77 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Height
|
172.1 cm
STANDARD_DEVIATION 9.19 • n=5 Participants
|
166.8 cm
STANDARD_DEVIATION 7.89 • n=7 Participants
|
172.6 cm
STANDARD_DEVIATION 9.61 • n=5 Participants
|
166.3 cm
STANDARD_DEVIATION 7.70 • n=4 Participants
|
173.9 cm
STANDARD_DEVIATION 8.82 • n=21 Participants
|
173.3 cm
STANDARD_DEVIATION 10.95 • n=8 Participants
|
172.5 cm
STANDARD_DEVIATION 10.35 • n=8 Participants
|
170.5 cm
STANDARD_DEVIATION 7.21 • n=24 Participants
|
171.8 cm
STANDARD_DEVIATION 7.46 • n=42 Participants
|
168.8 cm
STANDARD_DEVIATION 6.49 • n=42 Participants
|
171.0 cm
STANDARD_DEVIATION 8.44 • n=42 Participants
|
|
Age, Continuous
|
43.4 years
STANDARD_DEVIATION 4.20 • n=5 Participants
|
39.6 years
STANDARD_DEVIATION 9.90 • n=7 Participants
|
44.6 years
STANDARD_DEVIATION 9.00 • n=5 Participants
|
45.3 years
STANDARD_DEVIATION 8.19 • n=4 Participants
|
39.4 years
STANDARD_DEVIATION 8.14 • n=21 Participants
|
43.1 years
STANDARD_DEVIATION 11.34 • n=8 Participants
|
36.3 years
STANDARD_DEVIATION 9.78 • n=8 Participants
|
25.9 years
STANDARD_DEVIATION 9.51 • n=24 Participants
|
34.6 years
STANDARD_DEVIATION 10.61 • n=42 Participants
|
38.5 years
STANDARD_DEVIATION 11.52 • n=42 Participants
|
39.0 years
STANDARD_DEVIATION 10.52 • n=42 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
NA • n=5 Participants
|
4 Participants
NA • n=7 Participants
|
1 Participants
NA • n=5 Participants
|
3 Participants
NA • n=4 Participants
|
1 Participants
NA • n=21 Participants
|
4 Participants
n=8 Participants
|
2 Participants
9.78 • n=8 Participants
|
0 Participants
9.51 • n=24 Participants
|
0 Participants
10.61 • n=42 Participants
|
1 Participants
11.52 • n=42 Participants
|
19 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
8 Participants
n=24 Participants
|
8 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
58 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
1 participants
n=8 Participants
|
0 participants
n=8 Participants
|
0 participants
n=24 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
4 participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic or Latino
|
6 participants
n=5 Participants
|
7 participants
n=7 Participants
|
7 participants
n=5 Participants
|
8 participants
n=4 Participants
|
7 participants
n=21 Participants
|
8 participants
n=8 Participants
|
8 participants
n=8 Participants
|
8 participants
n=24 Participants
|
8 participants
n=42 Participants
|
6 participants
n=42 Participants
|
73 participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
8 participants
n=8 Participants
|
8 participants
n=24 Participants
|
8 participants
n=42 Participants
|
6 participants
n=42 Participants
|
31 participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
4 participants
n=5 Participants
|
7 participants
n=4 Participants
|
7 participants
n=21 Participants
|
8 participants
n=8 Participants
|
0 participants
n=8 Participants
|
0 participants
n=24 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
37 participants
n=42 Participants
|
|
Race/Ethnicity, Customized
White
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
2 participants
n=5 Participants
|
1 participants
n=4 Participants
|
0 participants
n=21 Participants
|
1 participants
n=8 Participants
|
0 participants
n=8 Participants
|
0 participants
n=24 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
8 participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Multiracial
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
0 participants
n=8 Participants
|
0 participants
n=8 Participants
|
0 participants
n=24 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
1 participants
n=42 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
8 participants
n=7 Participants
|
7 participants
n=5 Participants
|
8 participants
n=4 Participants
|
8 participants
n=21 Participants
|
9 participants
n=8 Participants
|
8 participants
n=8 Participants
|
8 participants
n=24 Participants
|
8 participants
n=42 Participants
|
6 participants
n=42 Participants
|
77 participants
n=42 Participants
|
|
Weight
|
92.09 kg
STANDARD_DEVIATION 10.138 • n=5 Participants
|
74.75 kg
STANDARD_DEVIATION 8.543 • n=7 Participants
|
83.76 kg
STANDARD_DEVIATION 19.701 • n=5 Participants
|
88.83 kg
STANDARD_DEVIATION 12.805 • n=4 Participants
|
83.51 kg
STANDARD_DEVIATION 11.853 • n=21 Participants
|
86.46 kg
STANDARD_DEVIATION 17.422 • n=8 Participants
|
73.98 kg
STANDARD_DEVIATION 10.503 • n=8 Participants
|
67.45 kg
STANDARD_DEVIATION 8.128 • n=24 Participants
|
70.19 kg
STANDARD_DEVIATION 6.879 • n=42 Participants
|
63.50 kg
STANDARD_DEVIATION 10.037 • n=42 Participants
|
78.70 kg
STANDARD_DEVIATION 14.666 • n=42 Participants
|
|
Body Mass Index (BMI)
|
31.13 kg/m^2
STANDARD_DEVIATION 3.266 • n=5 Participants
|
26.98 kg/m^2
STANDARD_DEVIATION 3.476 • n=7 Participants
|
27.93 kg/m^2
STANDARD_DEVIATION 5.488 • n=5 Participants
|
32.16 kg/m^2
STANDARD_DEVIATION 4.243 • n=4 Participants
|
27.76 kg/m^2
STANDARD_DEVIATION 4.460 • n=21 Participants
|
28.80 kg/m^2
STANDARD_DEVIATION 5.710 • n=8 Participants
|
24.75 kg/m^2
STANDARD_DEVIATION 1.962 • n=8 Participants
|
22.65 kg/m^2
STANDARD_DEVIATION 2.556 • n=24 Participants
|
24.14 kg/m^2
STANDARD_DEVIATION 1.984 • n=42 Participants
|
22.23 kg/m^2
STANDARD_DEVIATION 2.778 • n=42 Participants
|
26.93 kg/m^2
STANDARD_DEVIATION 4.812 • n=42 Participants
|
|
Caffeine Consumption
Yes
|
3 participants
n=5 Participants
|
8 participants
n=7 Participants
|
5 participants
n=5 Participants
|
5 participants
n=4 Participants
|
2 participants
n=21 Participants
|
8 participants
n=8 Participants
|
3 participants
n=8 Participants
|
4 participants
n=24 Participants
|
6 participants
n=42 Participants
|
3 participants
n=42 Participants
|
47 participants
n=42 Participants
|
|
Caffeine Consumption
No
|
4 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
3 participants
n=4 Participants
|
6 participants
n=21 Participants
|
1 participants
n=8 Participants
|
5 participants
n=8 Participants
|
4 participants
n=24 Participants
|
2 participants
n=42 Participants
|
3 participants
n=42 Participants
|
30 participants
n=42 Participants
|
|
Smoking Classification
Never smoked
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
2 participants
n=4 Participants
|
0 participants
n=21 Participants
|
1 participants
n=8 Participants
|
7 participants
n=8 Participants
|
2 participants
n=24 Participants
|
5 participants
n=42 Participants
|
2 participants
n=42 Participants
|
20 participants
n=42 Participants
|
|
Smoking Classification
Current smoker
|
5 participants
n=5 Participants
|
7 participants
n=7 Participants
|
6 participants
n=5 Participants
|
5 participants
n=4 Participants
|
7 participants
n=21 Participants
|
8 participants
n=8 Participants
|
0 participants
n=8 Participants
|
0 participants
n=24 Participants
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
38 participants
n=42 Participants
|
|
Smoking Classification
Ex-smoker
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
1 participants
n=21 Participants
|
0 participants
n=8 Participants
|
1 participants
n=8 Participants
|
6 participants
n=24 Participants
|
3 participants
n=42 Participants
|
4 participants
n=42 Participants
|
19 participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 14Population: Safety population included all randomized participants who received at least one dose of study drug.
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
Outcome measures
| Measure |
TAK-063 3 mg (Schizophrenia Participants)
n=7 Participants
TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 10 mg (Schizophrenia Participants)
n=8 Participants
TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 20 mg (Schizophrenia Participants)
n=7 Participants
TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 30 mg (Schizophrenia Participants)
n=8 Participants
TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 100 mg (Schizophrenia Participants)
n=8 Participants
TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
Placebo (Schizophrenia Participants)
n=9 Participants
Placebo matching TAK-063, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 3 mg (Healthy Participants)
n=8 Participants
TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
|
TAK-063 10 mg (Healthy Participants)
n=8 Participants
TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
|
TAK-063 20 mg (Healthy Participants)
n=8 Participants
TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
|
Placebo (Healthy Participants)
n=6 Participants
Placebo matching TAK-063, tablets, orally, once daily for 7 days in healthy Japanese participants.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Experience at Least One Treatment-Emergent Adverse Event (TEAE) After 7 Days of Dosing
|
57.1 percentage of participants
|
87.5 percentage of participants
|
71.4 percentage of participants
|
75.0 percentage of participants
|
100.0 percentage of participants
|
55.6 percentage of participants
|
50.0 percentage of participants
|
62.5 percentage of participants
|
62.5 percentage of participants
|
50.0 percentage of participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 8Population: Safety population included all randomized participants who received at least one dose of study drug.
The percentage of participants with any markedly abnormal standard safety laboratory values, including hematology, serum chemistries, and urinalysis, during the treatment period.
Outcome measures
| Measure |
TAK-063 3 mg (Schizophrenia Participants)
n=7 Participants
TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 10 mg (Schizophrenia Participants)
n=8 Participants
TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 20 mg (Schizophrenia Participants)
n=7 Participants
TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 30 mg (Schizophrenia Participants)
n=8 Participants
TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 100 mg (Schizophrenia Participants)
n=8 Participants
TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
Placebo (Schizophrenia Participants)
n=9 Participants
Placebo matching TAK-063, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 3 mg (Healthy Participants)
n=8 Participants
TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
|
TAK-063 10 mg (Healthy Participants)
n=8 Participants
TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
|
TAK-063 20 mg (Healthy Participants)
n=8 Participants
TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
|
Placebo (Healthy Participants)
n=6 Participants
Placebo matching TAK-063, tablets, orally, once daily for 7 days in healthy Japanese participants.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Markedly Abnormal Safety Laboratory Tests
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
25.0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 8Population: Safety population included all randomized participants who received at least one dose of study drug.
The percentage of participants who meet markedly abnormal criteria for vital signs, including oral body temperature, respiration rate, pulse, and resting blood pressure and after standing
Outcome measures
| Measure |
TAK-063 3 mg (Schizophrenia Participants)
n=7 Participants
TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 10 mg (Schizophrenia Participants)
n=8 Participants
TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 20 mg (Schizophrenia Participants)
n=7 Participants
TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 30 mg (Schizophrenia Participants)
n=8 Participants
TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 100 mg (Schizophrenia Participants)
n=8 Participants
TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
Placebo (Schizophrenia Participants)
n=9 Participants
Placebo matching TAK-063, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 3 mg (Healthy Participants)
n=8 Participants
TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
|
TAK-063 10 mg (Healthy Participants)
n=8 Participants
TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
|
TAK-063 20 mg (Healthy Participants)
n=8 Participants
TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
|
Placebo (Healthy Participants)
n=6 Participants
Placebo matching TAK-063, tablets, orally, once daily for 7 days in healthy Japanese participants.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Markedly Abnormal Vital Sign Measurements
|
71.4 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 8Population: Safety population included all randomized participants who received at least one dose of study drug.
The percentage of participants who meet markedly abnormal criteria specified by the protocol and statistical analysis plan during the treatment period.
Outcome measures
| Measure |
TAK-063 3 mg (Schizophrenia Participants)
n=7 Participants
TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 10 mg (Schizophrenia Participants)
n=8 Participants
TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 20 mg (Schizophrenia Participants)
n=7 Participants
TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 30 mg (Schizophrenia Participants)
n=8 Participants
TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 100 mg (Schizophrenia Participants)
n=8 Participants
TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
Placebo (Schizophrenia Participants)
n=9 Participants
Placebo matching TAK-063, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 3 mg (Healthy Participants)
n=8 Participants
TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
|
TAK-063 10 mg (Healthy Participants)
n=8 Participants
TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
|
TAK-063 20 mg (Healthy Participants)
n=8 Participants
TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
|
Placebo (Healthy Participants)
n=6 Participants
Placebo matching TAK-063, tablets, orally, once daily for 7 days in healthy Japanese participants.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Markedly Abnormal Values of 12-Lead Electrocardiogram (ECG) Parameters
|
57.1 percentage of participants
|
50.0 percentage of participants
|
57.1 percentage of participants
|
75.0 percentage of participants
|
62.5 percentage of participants
|
44.4 percentage of participants
|
50.0 percentage of participants
|
75.0 percentage of participants
|
50.0 percentage of participants
|
33.3 percentage of participants
|
SECONDARY outcome
Timeframe: Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours)Population: PK Set included all randomized participants who received study drug for whom PK data was available for analysis.
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Outcome measures
| Measure |
TAK-063 3 mg (Schizophrenia Participants)
n=7 Participants
TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 10 mg (Schizophrenia Participants)
n=8 Participants
TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 20 mg (Schizophrenia Participants)
n=7 Participants
TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 30 mg (Schizophrenia Participants)
n=8 Participants
TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 100 mg (Schizophrenia Participants)
n=7 Participants
TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
Placebo (Schizophrenia Participants)
n=8 Participants
Placebo matching TAK-063, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 3 mg (Healthy Participants)
n=8 Participants
TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
|
TAK-063 10 mg (Healthy Participants)
n=8 Participants
TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
|
TAK-063 20 mg (Healthy Participants)
TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
|
Placebo (Healthy Participants)
Placebo matching TAK-063, tablets, orally, once daily for 7 days in healthy Japanese participants.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Cmax: Maximum Observed Plasma Concentration for TAK-063 and TAK-063 Metabolite M-I
TAK-063 Day 1
|
17.0 ng/mL
Standard Deviation 7.2
|
62.8 ng/mL
Standard Deviation 16.6
|
95.1 ng/mL
Standard Deviation 30.8
|
151.4 ng/mL
Standard Deviation 31.9
|
211.3 ng/mL
Standard Deviation 84.8
|
14.9 ng/mL
Standard Deviation 5.3
|
69.4 ng/mL
Standard Deviation 13.2
|
116.2 ng/mL
Standard Deviation 17.9
|
—
|
—
|
|
Cmax: Maximum Observed Plasma Concentration for TAK-063 and TAK-063 Metabolite M-I
TAK-063 M-I Day 1
|
11.3 ng/mL
Standard Deviation 4.2
|
64.8 ng/mL
Standard Deviation 21.5
|
98.5 ng/mL
Standard Deviation 29.1
|
93.2 ng/mL
Standard Deviation 4.8
|
126.7 ng/mL
Standard Deviation 29.9
|
8.8 ng/mL
Standard Deviation 1.7
|
36.0 ng/mL
Standard Deviation 5.0
|
61.8 ng/mL
Standard Deviation 11.2
|
—
|
—
|
|
Cmax: Maximum Observed Plasma Concentration for TAK-063 and TAK-063 Metabolite M-I
TAK-063 Day 7 (n=7, 7, 7, 7, 7, 8, 7, 6)
|
25.6 ng/mL
Standard Deviation 4.6
|
70.3 ng/mL
Standard Deviation 11.5
|
120.0 ng/mL
Standard Deviation 39.3
|
179.4 ng/mL
Standard Deviation 34.9
|
228.3 ng/mL
Standard Deviation 55.1
|
29.1 ng/mL
Standard Deviation 8.0
|
74.6 ng/mL
Standard Deviation 12.5
|
139.8 ng/mL
Standard Deviation 25.4
|
—
|
—
|
|
Cmax: Maximum Observed Plasma Concentration for TAK-063 and TAK-063 Metabolite M-I
TAK-063 M-I Day 7 (n=7, 7, 7, 7, 7, 8, 7, 6)
|
19.2 ng/mL
Standard Deviation 4.2
|
74.8 ng/mL
Standard Deviation 20.3
|
123.6 ng/mL
Standard Deviation 48.2
|
108.5 ng/mL
Standard Deviation 15.8
|
127.7 ng/mL
Standard Deviation 22.6
|
15.1 ng/mL
Standard Deviation 2.4
|
38.2 ng/mL
Standard Deviation 4.4
|
70.9 ng/mL
Standard Deviation 17.8
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours)Population: PK Set included all randomized participants who received study drug for whom PK data was available for analysis.
Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.
Outcome measures
| Measure |
TAK-063 3 mg (Schizophrenia Participants)
n=7 Participants
TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 10 mg (Schizophrenia Participants)
n=8 Participants
TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 20 mg (Schizophrenia Participants)
n=7 Participants
TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 30 mg (Schizophrenia Participants)
n=8 Participants
TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 100 mg (Schizophrenia Participants)
n=7 Participants
TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
Placebo (Schizophrenia Participants)
n=8 Participants
Placebo matching TAK-063, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 3 mg (Healthy Participants)
n=8 Participants
TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
|
TAK-063 10 mg (Healthy Participants)
n=8 Participants
TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
|
TAK-063 20 mg (Healthy Participants)
TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
|
Placebo (Healthy Participants)
Placebo matching TAK-063, tablets, orally, once daily for 7 days in healthy Japanese participants.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-063 and TAK-063 Metabolite M-I
TAK-063 M-I Day 1
|
3.0 hour
Interval 1.0 to 6.0
|
2.0 hour
Interval 1.5 to 6.0
|
3.0 hour
Interval 3.0 to 4.0
|
3.1 hour
Interval 2.0 to 6.5
|
3.0 hour
Interval 2.0 to 6.0
|
2.5 hour
Interval 1.5 to 4.0
|
3.0 hour
Interval 2.0 to 6.0
|
3.0 hour
Interval 1.5 to 4.0
|
—
|
—
|
|
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-063 and TAK-063 Metabolite M-I
TAK-063 Day 7 (n=7, 7, 7, 7, 7, 8, 7, 6)
|
3.0 hour
Interval 2.0 to 6.0
|
3.0 hour
Interval 1.0 to 6.0
|
3.0 hour
Interval 2.0 to 4.0
|
3.0 hour
Interval 1.5 to 3.0
|
3.0 hour
Interval 2.0 to 3.3
|
3.0 hour
Interval 1.5 to 4.0
|
1.5 hour
Interval 1.0 to 6.0
|
2.5 hour
Interval 1.5 to 4.0
|
—
|
—
|
|
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-063 and TAK-063 Metabolite M-I
TAK-063 Day 1
|
3.0 hour
Interval 1.0 to 6.0
|
2.0 hour
Interval 1.5 to 4.0
|
3.0 hour
Interval 3.0 to 3.0
|
3.0 hour
Interval 2.0 to 4.0
|
4.0 hour
Interval 2.0 to 6.0
|
3.0 hour
Interval 1.5 to 4.0
|
3.0 hour
Interval 2.0 to 8.0
|
2.5 hour
Interval 1.5 to 4.0
|
—
|
—
|
|
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-063 and TAK-063 Metabolite M-I
TAK-063 M-I Day 7 (n=7, 7, 7, 7, 7, 8, 7, 6)
|
4.0 hour
Interval 2.0 to 6.0
|
3.0 hour
Interval 1.5 to 6.0
|
3.0 hour
Interval 2.0 to 4.0
|
3.0 hour
Interval 2.0 to 4.0
|
3.0 hour
Interval 2.0 to 4.0
|
3.0 hour
Interval 2.0 to 4.0
|
3.0 hour
Interval 1.5 to 6.0
|
3.0 hour
Interval 3.0 to 4.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours)Population: PK Set included all randomized participants who received study drug for whom PK data was available for analysis.
AUC(0-tlqc) is a measure of total plasma exposure to the drug from time 0 to time of the Last Quantifiable Concentration.
Outcome measures
| Measure |
TAK-063 3 mg (Schizophrenia Participants)
n=7 Participants
TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 10 mg (Schizophrenia Participants)
n=8 Participants
TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 20 mg (Schizophrenia Participants)
n=7 Participants
TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 30 mg (Schizophrenia Participants)
n=8 Participants
TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 100 mg (Schizophrenia Participants)
n=7 Participants
TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
Placebo (Schizophrenia Participants)
n=8 Participants
Placebo matching TAK-063, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 3 mg (Healthy Participants)
n=8 Participants
TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
|
TAK-063 10 mg (Healthy Participants)
n=8 Participants
TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
|
TAK-063 20 mg (Healthy Participants)
TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
|
Placebo (Healthy Participants)
Placebo matching TAK-063, tablets, orally, once daily for 7 days in healthy Japanese participants.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-063 and TAK-063 Metabolite M-I
TAK-063 Day 7 (n=7, 7, 7, 7, 7, 8, 7, 6)
|
280.8 ng*hr/mL
Standard Deviation 60.4
|
680.3 ng*hr/mL
Standard Deviation 153.4
|
1240.9 ng*hr/mL
Standard Deviation 385.4
|
2030.9 ng*hr/mL
Standard Deviation 479.2
|
2764.5 ng*hr/mL
Standard Deviation 711.4
|
295.6 ng*hr/mL
Standard Deviation 83.5
|
736.1 ng*hr/mL
Standard Deviation 90.7
|
1536.7 ng*hr/mL
Standard Deviation 236.7
|
—
|
—
|
|
AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-063 and TAK-063 Metabolite M-I
TAK-063 Day 1
|
158.8 ng*hr/mL
Standard Deviation 59.8
|
622.7 ng*hr/mL
Standard Deviation 140.9
|
938.3 ng*hr/mL
Standard Deviation 401.0
|
1616.6 ng*hr/mL
Standard Deviation 392.1
|
2499.3 ng*hr/mL
Standard Deviation 1143.3
|
148.3 ng*hr/mL
Standard Deviation 54.8
|
651.3 ng*hr/mL
Standard Deviation 73.2
|
1242.3 ng*hr/mL
Standard Deviation 275.4
|
—
|
—
|
|
AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-063 and TAK-063 Metabolite M-I
TAK-063 M-I Day 1
|
113.9 ng*hr/mL
Standard Deviation 48.9
|
681.8 ng*hr/mL
Standard Deviation 268.9
|
1009.6 ng*hr/mL
Standard Deviation 516.5
|
1069.1 ng*hr/mL
Standard Deviation 120.2
|
1481.1 ng*hr/mL
Standard Deviation 404.5
|
74.7 ng*hr/mL
Standard Deviation 19.1
|
327.6 ng*hr/mL
Standard Deviation 37.4
|
666.3 ng*hr/mL
Standard Deviation 148.8
|
—
|
—
|
|
AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-063 and TAK-063 Metabolite M-I
TAK-063 M-I Day 7 (n=7, 7, 7, 7, 7, 8, 7, 6)
|
218.9 ng*hr/mL
Standard Deviation 56.9
|
786.3 ng*hr/mL
Standard Deviation 296.6
|
1387.2 ng*hr/mL
Standard Deviation 681.0
|
1371.2 ng*hr/mL
Standard Deviation 291.8
|
1598.8 ng*hr/mL
Standard Deviation 288.7
|
156.7 ng*hr/mL
Standard Deviation 37.3
|
378.5 ng*hr/mL
Standard Deviation 51.6
|
806.5 ng*hr/mL
Standard Deviation 174.3
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours)Population: PK Set included all randomized participants who received study drug for whom PK data was available for analysis.
AUC(0-24) is a measure of total plasma exposure to the drug from Time 0 to 24 hours post-dose.
Outcome measures
| Measure |
TAK-063 3 mg (Schizophrenia Participants)
n=7 Participants
TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 10 mg (Schizophrenia Participants)
n=8 Participants
TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 20 mg (Schizophrenia Participants)
n=7 Participants
TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 30 mg (Schizophrenia Participants)
n=8 Participants
TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 100 mg (Schizophrenia Participants)
n=7 Participants
TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
Placebo (Schizophrenia Participants)
n=8 Participants
Placebo matching TAK-063, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 3 mg (Healthy Participants)
n=8 Participants
TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
|
TAK-063 10 mg (Healthy Participants)
n=8 Participants
TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
|
TAK-063 20 mg (Healthy Participants)
TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
|
Placebo (Healthy Participants)
Placebo matching TAK-063, tablets, orally, once daily for 7 days in healthy Japanese participants.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Postdose for TAK-063 and TAK-063 Metabolite M-I
TAK-063 Day 1
|
159.0 ng*hr/mL
Standard Deviation 60.0
|
623.2 ng*hr/mL
Standard Deviation 141.0
|
939.3 ng*hr/mL
Standard Deviation 402.0
|
1619.0 ng*hr/mL
Standard Deviation 393.3
|
2503.2 ng*hr/mL
Standard Deviation 1146.4
|
148.6 ng*hr/mL
Standard Deviation 54.9
|
651.9 ng*hr/mL
Standard Deviation 73.3
|
1243.9 ng*hr/mL
Standard Deviation 276.0
|
—
|
—
|
|
AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Postdose for TAK-063 and TAK-063 Metabolite M-I
TAK-063 M-I Day 1
|
114.0 ng*hr/mL
Standard Deviation 49.1
|
682.5 ng*hr/mL
Standard Deviation 269.0
|
1011.0 ng*hr/mL
Standard Deviation 517.9
|
1070.8 ng*hr/mL
Standard Deviation 120.7
|
1483.6 ng*hr/mL
Standard Deviation 405.8
|
74.8 ng*hr/mL
Standard Deviation 19.2
|
327.9 ng*hr/mL
Standard Deviation 37.5
|
667.3 ng*hr/mL
Standard Deviation 149.1
|
—
|
—
|
|
AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Postdose for TAK-063 and TAK-063 Metabolite M-I
TAK-063 Day 7 (n=7, 7, 7, 7, 7, 8, 7, 6)
|
280.6 ng*hr/mL
Standard Deviation 60.5
|
680.1 ng*hr/mL
Standard Deviation 153.3
|
1240.9 ng*hr/mL
Standard Deviation 385.4
|
2030.9 ng*hr/mL
Standard Deviation 479.2
|
2764.0 ng*hr/mL
Standard Deviation 712.1
|
295.6 ng*hr/mL
Standard Deviation 83.5
|
736.1 ng*hr/mL
Standard Deviation 90.6
|
1536.4 ng*hr/mL
Standard Deviation 236.2
|
—
|
—
|
|
AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Postdose for TAK-063 and TAK-063 Metabolite M-I
TAK-063 M-I Day 7 (n=7, 7, 7, 7, 7, 8, 7, 6)
|
218.7 ng*hr/mL
Standard Deviation 57.0
|
786.0 ng*hr/mL
Standard Deviation 296.4
|
1387.2 ng*hr/mL
Standard Deviation 681.0
|
1371.2 ng*hr/mL
Standard Deviation 291.8
|
1598.4 ng*hr/mL
Standard Deviation 289.1
|
156.7 ng*hr/mL
Standard Deviation 37.3
|
378.5 ng*hr/mL
Standard Deviation 51.6
|
806.3 ng*hr/mL
Standard Deviation 174.1
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours)Population: PK Set included all randomized participants who received study drug for whom PK data was available for analysis.
CL/F is apparent clearance of the drug from the plasma, calculated as the drug dose divided by area under the curve from time 0 to 24 hours post-dose, after multiple dosing (at steady state).
Outcome measures
| Measure |
TAK-063 3 mg (Schizophrenia Participants)
n=7 Participants
TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 10 mg (Schizophrenia Participants)
n=8 Participants
TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 20 mg (Schizophrenia Participants)
n=7 Participants
TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 30 mg (Schizophrenia Participants)
n=8 Participants
TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 100 mg (Schizophrenia Participants)
n=7 Participants
TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
Placebo (Schizophrenia Participants)
n=8 Participants
Placebo matching TAK-063, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 3 mg (Healthy Participants)
n=8 Participants
TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
|
TAK-063 10 mg (Healthy Participants)
n=8 Participants
TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
|
TAK-063 20 mg (Healthy Participants)
TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
|
Placebo (Healthy Participants)
Placebo matching TAK-063, tablets, orally, once daily for 7 days in healthy Japanese participants.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
CL/F: Oral Clearance of TAK-063
TAK-063 Day 1
|
16.1 liter/hour
Standard Deviation 7.3
|
14.0 liter/hour
Standard Deviation 4.3
|
21.3 liter/hour
Standard Deviation 8.0
|
14.4 liter/hour
Standard Deviation 5.4
|
38.1 liter/hour
Standard Deviation 25.0
|
16.9 liter/hour
Standard Deviation 5.2
|
13.9 liter/hour
Standard Deviation 2.0
|
13.9 liter/hour
Standard Deviation 4.6
|
—
|
—
|
|
CL/F: Oral Clearance of TAK-063
TAK-063 Day 7 (n=7, 7, 7, 7, 7, 8, 7, 6)
|
11.2 liter/hour
Standard Deviation 2.7
|
15.4 liter/hour
Standard Deviation 3.9
|
17.1 liter/hour
Standard Deviation 4.0
|
15.5 liter/hour
Standard Deviation 3.5
|
38.5 liter/hour
Standard Deviation 10.8
|
10.8 liter/hour
Standard Deviation 2.8
|
13.8 liter/hour
Standard Deviation 1.6
|
13.3 liter/hour
Standard Deviation 1.9
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours)Population: PK Set included all randomized participants for whom PK data was available for analysis.
Cav is the Average plasma concentration on Day 1, calculated as AUC(0-24)/24 on Day 1. Cavss is the average plasma concentration on Day 7, calculated as AUC(0-24)/24 on Day 7.
Outcome measures
| Measure |
TAK-063 3 mg (Schizophrenia Participants)
n=7 Participants
TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 10 mg (Schizophrenia Participants)
n=8 Participants
TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 20 mg (Schizophrenia Participants)
n=7 Participants
TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 30 mg (Schizophrenia Participants)
n=8 Participants
TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 100 mg (Schizophrenia Participants)
n=7 Participants
TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
Placebo (Schizophrenia Participants)
n=8 Participants
Placebo matching TAK-063, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 3 mg (Healthy Participants)
n=8 Participants
TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
|
TAK-063 10 mg (Healthy Participants)
n=8 Participants
TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
|
TAK-063 20 mg (Healthy Participants)
TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
|
Placebo (Healthy Participants)
Placebo matching TAK-063, tablets, orally, once daily for 7 days in healthy Japanese participants.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Average Plasma Concentration on Day 1 (Cav) and Day 7 (Cavss) for TAK-063 and TAK-063 Metabolite M-I
TAK-063 M-I Day 1
|
4.8 ng/mL
Standard Deviation 2.0
|
28.4 ng/mL
Standard Deviation 11.2
|
42.1 ng/mL
Standard Deviation 21.6
|
44.6 ng/mL
Standard Deviation 5.0
|
61.8 ng/mL
Standard Deviation 16.9
|
3.1 ng/mL
Standard Deviation 0.8
|
13.7 ng/mL
Standard Deviation 1.6
|
27.8 ng/mL
Standard Deviation 6.2
|
—
|
—
|
|
Average Plasma Concentration on Day 1 (Cav) and Day 7 (Cavss) for TAK-063 and TAK-063 Metabolite M-I
TAK-063 Day 1
|
6.6 ng/mL
Standard Deviation 2.5
|
26.0 ng/mL
Standard Deviation 5.9
|
39.1 ng/mL
Standard Deviation 16.8
|
67.5 ng/mL
Standard Deviation 16.4
|
104.3 ng/mL
Standard Deviation 47.8
|
6.2 ng/mL
Standard Deviation 2.3
|
27.2 ng/mL
Standard Deviation 3.1
|
51.8 ng/mL
Standard Deviation 11.5
|
—
|
—
|
|
Average Plasma Concentration on Day 1 (Cav) and Day 7 (Cavss) for TAK-063 and TAK-063 Metabolite M-I
TAK-063 Day 7 (n=7, 7, 7, 7, 7, 8, 7, 6)
|
11.7 ng/mL
Standard Deviation 2.5
|
28.3 ng/mL
Standard Deviation 6.4
|
51.7 ng/mL
Standard Deviation 16.1
|
84.6 ng/mL
Standard Deviation 20.0
|
115.2 ng/mL
Standard Deviation 29.7
|
12.3 ng/mL
Standard Deviation 3.5
|
30.7 ng/mL
Standard Deviation 3.8
|
64.0 ng/mL
Standard Deviation 9.8
|
—
|
—
|
|
Average Plasma Concentration on Day 1 (Cav) and Day 7 (Cavss) for TAK-063 and TAK-063 Metabolite M-I
TAK-063 M-I Day 7 (n=7, 7, 7, 7, 7, 8, 7, 6)
|
9.1 ng/mL
Standard Deviation 2.4
|
32.8 ng/mL
Standard Deviation 12.4
|
57.8 ng/mL
Standard Deviation 28.4
|
57.1 ng/mL
Standard Deviation 12.2
|
66.6 ng/mL
Standard Deviation 12.0
|
6.5 ng/mL
Standard Deviation 1.6
|
15.8 ng/mL
Standard Deviation 2.2
|
33.6 ng/mL
Standard Deviation 7.3
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours)Population: PK Set included all randomized participants who received study drug for whom PK data was available for analysis.
Cmax Molar Ratio is the ratio of Cmax molar values of the metabolite compared to the parent calculated by dividing Cmax molar values of metabolite M-I with those of TAK-063.
Outcome measures
| Measure |
TAK-063 3 mg (Schizophrenia Participants)
n=7 Participants
TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 10 mg (Schizophrenia Participants)
n=8 Participants
TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 20 mg (Schizophrenia Participants)
n=7 Participants
TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 30 mg (Schizophrenia Participants)
n=8 Participants
TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 100 mg (Schizophrenia Participants)
n=7 Participants
TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
Placebo (Schizophrenia Participants)
n=8 Participants
Placebo matching TAK-063, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 3 mg (Healthy Participants)
n=8 Participants
TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
|
TAK-063 10 mg (Healthy Participants)
n=8 Participants
TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
|
TAK-063 20 mg (Healthy Participants)
TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
|
Placebo (Healthy Participants)
Placebo matching TAK-063, tablets, orally, once daily for 7 days in healthy Japanese participants.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Cmax Molar Ratio: Ratio of TAK-063 Metabolite Cmax to TAK-063 Cmax
TAK-063 M-I Day 1
|
0.7 ratio
Standard Deviation 0.1
|
1.0 ratio
Standard Deviation 0.2
|
1.0 ratio
Standard Deviation 0.2
|
0.6 ratio
Standard Deviation 0.1
|
0.6 ratio
Standard Deviation 0.2
|
0.6 ratio
Standard Deviation 0.2
|
0.5 ratio
Standard Deviation 0.1
|
0.5 ratio
Standard Deviation 0.1
|
—
|
—
|
|
Cmax Molar Ratio: Ratio of TAK-063 Metabolite Cmax to TAK-063 Cmax
TAK-063 M-I Day 7 (n=7, 7, 7, 7, 7, 8, 7, 6)
|
0.7 ratio
Standard Deviation 0.2
|
1.0 ratio
Standard Deviation 0.2
|
1.0 ratio
Standard Deviation 0.2
|
0.6 ratio
Standard Deviation 0.1
|
0.6 ratio
Standard Deviation 0.1
|
0.5 ratio
Standard Deviation 0.1
|
0.5 ratio
Standard Deviation 0.1
|
0.5 ratio
Standard Deviation 0.1
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours)Population: PK Set included all randomized participants who received study drug for whom PK data was available for analysis.
AUC(0-24) Ratio is the ratio of AUC(0-24) values of the metabolite compared to the parent calculated by dividing AUC(0-24) values of metabolite M-I with those of the parent drug TAK-063.
Outcome measures
| Measure |
TAK-063 3 mg (Schizophrenia Participants)
n=7 Participants
TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 10 mg (Schizophrenia Participants)
n=8 Participants
TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 20 mg (Schizophrenia Participants)
n=7 Participants
TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 30 mg (Schizophrenia Participants)
n=8 Participants
TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 100 mg (Schizophrenia Participants)
n=7 Participants
TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
Placebo (Schizophrenia Participants)
n=8 Participants
Placebo matching TAK-063, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 3 mg (Healthy Participants)
n=8 Participants
TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
|
TAK-063 10 mg (Healthy Participants)
n=8 Participants
TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
|
TAK-063 20 mg (Healthy Participants)
TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
|
Placebo (Healthy Participants)
Placebo matching TAK-063, tablets, orally, once daily for 7 days in healthy Japanese participants.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
AUC(0-24) Ratio: Ratio of TAK-063 Metabolite AUC(0-24) to TAK-063 AUC(0-24)
TAK-063 M-I Day 1
|
0.7 ratio
Standard Deviation 0.1
|
1.0 ratio
Standard Deviation 0.3
|
1.0 ratio
Standard Deviation 0.2
|
0.7 ratio
Standard Deviation 0.1
|
0.6 ratio
Standard Deviation 0.2
|
0.5 ratio
Standard Deviation 0.1
|
0.5 ratio
Standard Deviation 0.1
|
0.5 ratio
Standard Deviation 0.1
|
—
|
—
|
|
AUC(0-24) Ratio: Ratio of TAK-063 Metabolite AUC(0-24) to TAK-063 AUC(0-24)
TAK-063 M-I Day 7 (n=7, 7, 7, 7, 7, 8, 7, 6)
|
0.8 ratio
Standard Deviation 0.2
|
1.1 ratio
Standard Deviation 0.3
|
1.1 ratio
Standard Deviation 0.2
|
0.7 ratio
Standard Deviation 0.1
|
0.6 ratio
Standard Deviation 0.1
|
0.5 ratio
Standard Deviation 0.04
|
0.5 ratio
Standard Deviation 0.1
|
0.5 ratio
Standard Deviation 0.1
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours)Population: PK Set included all randomized participants who received study drug for whom PK data was available for analysis.
Accumulation ratios between Day 7 AUC(0-24) and Day 1 AUC(0-24), (Day 7/Day 1). Estimated Ratio (Day 7/Day 1) is the exponentiated results of the difference between Day 7 and Day 1 in log-transformed values which resolves to the ratio of Day 7/Day 1 estimates.
Outcome measures
| Measure |
TAK-063 3 mg (Schizophrenia Participants)
n=7 Participants
TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 10 mg (Schizophrenia Participants)
n=7 Participants
TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 20 mg (Schizophrenia Participants)
n=7 Participants
TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 30 mg (Schizophrenia Participants)
n=7 Participants
TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 100 mg (Schizophrenia Participants)
n=7 Participants
TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
Placebo (Schizophrenia Participants)
n=8 Participants
Placebo matching TAK-063, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 3 mg (Healthy Participants)
n=7 Participants
TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
|
TAK-063 10 mg (Healthy Participants)
n=6 Participants
TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
|
TAK-063 20 mg (Healthy Participants)
TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
|
Placebo (Healthy Participants)
Placebo matching TAK-063, tablets, orally, once daily for 7 days in healthy Japanese participants.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Accumulation Ratios Between Day 7 AUC(0-24) and Day 1 AUC(0-24)
TAK-063
|
1.8 ratio
90% Confidence Interval 0.550 • Interval 1.6 to 2.1
|
1.1 ratio
90% Confidence Interval 0.210 • Interval 1.0 to 1.3
|
1.4 ratio
90% Confidence Interval 0.325 • Interval 1.2 to 1.6
|
1.3 ratio
90% Confidence Interval 0.126 • Interval 1.1 to 1.5
|
1.2 ratio
90% Confidence Interval 0.324 • Interval 1.0 to 1.4
|
2.0 ratio
90% Confidence Interval 0.472 • Interval 1.8 to 2.3
|
1.1 ratio
90% Confidence Interval 0.169 • Interval 1.0 to 1.3
|
1.2 ratio
90% Confidence Interval 0.180 • Interval 1.0 to 1.3
|
—
|
—
|
|
Accumulation Ratios Between Day 7 AUC(0-24) and Day 1 AUC(0-24)
TAK-063 M-I
|
2.0 ratio
90% Confidence Interval 0.619 • Interval 1.7 to 2.4
|
1.2 ratio
90% Confidence Interval 0.308 • Interval 1.0 to 1.4
|
1.4 ratio
90% Confidence Interval 0.371 • Interval 1.2 to 1.6
|
1.3 ratio
90% Confidence Interval 0.183 • Interval 1.1 to 1.5
|
1.1 ratio
90% Confidence Interval 0.243 • Interval 0.9 to 1.3
|
2.1 ratio
90% Confidence Interval 0.408 • Interval 1.9 to 2.3
|
1.1 ratio
90% Confidence Interval 0.158 • Interval 1.0 to 1.3
|
1.1 ratio
90% Confidence Interval 0.226 • Interval 1.0 to 1.3
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours)Population: PK Set included all randomized participants who received study drug for whom PK data was available for analysis.
Ae(0-24) is a measure of the total amount of study drug excreted in the urine from time 0 to 24 hours postdose.
Outcome measures
| Measure |
TAK-063 3 mg (Schizophrenia Participants)
n=7 Participants
TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 10 mg (Schizophrenia Participants)
n=8 Participants
TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 20 mg (Schizophrenia Participants)
n=7 Participants
TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 30 mg (Schizophrenia Participants)
n=8 Participants
TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 100 mg (Schizophrenia Participants)
n=7 Participants
TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
Placebo (Schizophrenia Participants)
n=8 Participants
Placebo matching TAK-063, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 3 mg (Healthy Participants)
n=8 Participants
TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
|
TAK-063 10 mg (Healthy Participants)
n=8 Participants
TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
|
TAK-063 20 mg (Healthy Participants)
TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
|
Placebo (Healthy Participants)
Placebo matching TAK-063, tablets, orally, once daily for 7 days in healthy Japanese participants.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Ae(0-24): Total Amount Excreted in the Urine From Time 0 to 24 Hours Postdose for TAK-063 and TAK-063 Metabolite M-I
TAK-063 M-I Day 1
|
0.0 ng
Standard Deviation 0.0
|
9099.4 ng
Standard Deviation 3451.0
|
16879.5 ng
Standard Deviation 8061.5
|
24302.0 ng
Standard Deviation 12756.6
|
52682.9 ng
Standard Deviation 14870.1
|
0.0 ng
Standard Deviation 0.0
|
10487.8 ng
Standard Deviation 5847.3
|
26557.0 ng
Standard Deviation 11839.7
|
—
|
—
|
|
Ae(0-24): Total Amount Excreted in the Urine From Time 0 to 24 Hours Postdose for TAK-063 and TAK-063 Metabolite M-I
TAK-063 Day 1
|
0.0 ng
Standard Deviation 0.0
|
3642.3 ng
Standard Deviation 2611.9
|
4432.8 ng
Standard Deviation 3418.6
|
9952.1 ng
Standard Deviation 6025.2
|
34893.4 ng
Standard Deviation 27402.5
|
0.0 ng
Standard Deviation 0.0
|
3592.0 ng
Standard Deviation 4936.1
|
14145.4 ng
Standard Deviation 9576.1
|
—
|
—
|
|
Ae(0-24): Total Amount Excreted in the Urine From Time 0 to 24 Hours Postdose for TAK-063 and TAK-063 Metabolite M-I
TAK-063 Day 7 (n=7, 7, 7, 7, 7, 8, 7, 6)
|
0.0 ng
Standard Deviation 0.0
|
4430.9 ng
Standard Deviation 2831.5
|
7979.2 ng
Standard Deviation 4739.0
|
15066.0 ng
Standard Deviation 9996.7
|
35527.5 ng
Standard Deviation 20919.1
|
0.0 ng
Standard Deviation 0.0
|
4765.2 ng
Standard Deviation 3491.0
|
15913.7 ng
Standard Deviation 9619.6
|
—
|
—
|
|
Ae(0-24): Total Amount Excreted in the Urine From Time 0 to 24 Hours Postdose for TAK-063 and TAK-063 Metabolite M-I
TAK-063 M-I Day 7 (n=7, 7, 7, 7, 7, 8, 7, 6)
|
630.2 ng
Standard Deviation 1129.4
|
11708.6 ng
Standard Deviation 7047.1
|
25327.7 ng
Standard Deviation 12723.6
|
35462.0 ng
Standard Deviation 11737.9
|
67767.6 ng
Standard Deviation 36686.1
|
1024.2 ng
Standard Deviation 1665.5
|
14139.9 ng
Standard Deviation 8205.9
|
35341.3 ng
Standard Deviation 12664.4
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours)Population: PK Set included all randomized participants who received study drug for whom PK data was available for analysis.
Fe is a measure of the fraction of drug excreted in urine and is calculated as Fe = (total amount excreted in the urine from time 0 to 24 hours post-dose / dose)×100
Outcome measures
| Measure |
TAK-063 3 mg (Schizophrenia Participants)
n=7 Participants
TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 10 mg (Schizophrenia Participants)
n=8 Participants
TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 20 mg (Schizophrenia Participants)
n=7 Participants
TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 30 mg (Schizophrenia Participants)
n=8 Participants
TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 100 mg (Schizophrenia Participants)
n=7 Participants
TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
Placebo (Schizophrenia Participants)
n=8 Participants
Placebo matching TAK-063, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 3 mg (Healthy Participants)
n=8 Participants
TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
|
TAK-063 10 mg (Healthy Participants)
n=8 Participants
TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
|
TAK-063 20 mg (Healthy Participants)
TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
|
Placebo (Healthy Participants)
Placebo matching TAK-063, tablets, orally, once daily for 7 days in healthy Japanese participants.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Fe: Fraction of Drug Excreted in Urine for TAK-063
Day 1
|
0.00 percent
Standard Deviation 0.00
|
0.04 percent
Standard Deviation 0.03
|
0.02 percent
Standard Deviation 0.02
|
0.03 percent
Standard Deviation 0.02
|
0.03 percent
Standard Deviation 0.03
|
0.00 percent
Standard Deviation 0.00
|
0.04 percent
Standard Deviation 0.05
|
0.07 percent
Standard Deviation 0.05
|
—
|
—
|
|
Fe: Fraction of Drug Excreted in Urine for TAK-063
Day 7 (n=7, 7, 7, 7, 7, 8, 7, 6)
|
0.00 percent
Standard Deviation 0.00
|
0.04 percent
Standard Deviation 0.03
|
0.04 percent
Standard Deviation 0.02
|
0.05 percent
Standard Deviation 0.03
|
0.04 percent
Standard Deviation 0.02
|
0.00 percent
Standard Deviation 0.00
|
0.05 percent
Standard Deviation 0.03
|
0.08 percent
Standard Deviation 0.05
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours)Population: PK Set included all randomized participants who received study drug for whom PK data was available for analysis.
CLr is a measure of apparent clearance of the drug from the urine calculated as total amount excreted in the urine from time 0 to 24 hours postdose / plasma area under the curve from time 0 to 24 hours post-dose.
Outcome measures
| Measure |
TAK-063 3 mg (Schizophrenia Participants)
n=2 Participants
TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 10 mg (Schizophrenia Participants)
n=8 Participants
TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 20 mg (Schizophrenia Participants)
n=6 Participants
TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 30 mg (Schizophrenia Participants)
n=7 Participants
TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 100 mg (Schizophrenia Participants)
n=7 Participants
TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
Placebo (Schizophrenia Participants)
n=3 Participants
Placebo matching TAK-063, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 3 mg (Healthy Participants)
n=7 Participants
TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
|
TAK-063 10 mg (Healthy Participants)
n=8 Participants
TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
|
TAK-063 20 mg (Healthy Participants)
TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
|
Placebo (Healthy Participants)
Placebo matching TAK-063, tablets, orally, once daily for 7 days in healthy Japanese participants.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
CLr: Renal Clearance of TAK-063 and TAK-063 Metabolite M-I
TAK-063 Day 1 (n=0, 6, 6, 7, 7, 0, 6, 7)
|
NA mL/hour
Standard Deviation NA
CLr could not be calculated because the concentrations in urine were low/not detected.
|
8.4 mL/hour
Standard Deviation 3.9
|
5.2 mL/hour
Standard Deviation 2.5
|
6.7 mL/hour
Standard Deviation 1.6
|
16.2 mL/hour
Standard Deviation 13.1
|
NA mL/hour
Standard Deviation NA
CLr could not be calculated because the concentrations in urine were low/not detected.
|
7.0 mL/hour
Standard Deviation 7.0
|
12.9 mL/hour
Standard Deviation 7.5
|
—
|
—
|
|
CLr: Renal Clearance of TAK-063 and TAK-063 Metabolite M-I
TAK-063 M-I Day 1 (n=0, 8, 6, 7, 7, 0, 7, 8)
|
NA mL/hour
Standard Deviation NA
CLr could not be calculated because the concentrations in urine were low/not detected.
|
15.9 mL/hour
Standard Deviation 10.7
|
20.4 mL/hour
Standard Deviation 8.0
|
25.6 mL/hour
Standard Deviation 9.3
|
36.8 mL/hour
Standard Deviation 11.9
|
NA mL/hour
Standard Deviation NA
CLr could not be calculated because the concentrations in urine were low/not detected.
|
38.0 mL/hour
Standard Deviation 16.4
|
39.9 mL/hour
Standard Deviation 16.1
|
—
|
—
|
|
CLr: Renal Clearance of TAK-063 and TAK-063 Metabolite M-I
TAK-063 Day 7 (n=0, 7, 6, 7, 7, 0, 6, 6)
|
NA mL/hour
Standard Deviation NA
CLr could not be calculated because the concentrations in urine were low/not detected.
|
6.8 mL/hour
Standard Deviation 4.4
|
7.2 mL/hour
Standard Deviation 1.1
|
7.3 mL/hour
Standard Deviation 3.4
|
13.3 mL/hour
Standard Deviation 7.3
|
NA mL/hour
Standard Deviation NA
CLr could not be calculated because the concentrations in urine were low/not detected.
|
7.3 mL/hour
Standard Deviation 3.2
|
10.5 mL/hour
Standard Deviation 6.3
|
—
|
—
|
|
CLr: Renal Clearance of TAK-063 and TAK-063 Metabolite M-I
TAK-063 M-I Day 7 (n=2, 7, 6, 7, 7, 3, 6, 6)
|
11.3 mL/hour
Standard Deviation 6.7
|
16.9 mL/hour
Standard Deviation 15.5
|
21.7 mL/hour
Standard Deviation 8.8
|
26.4 mL/hour
Standard Deviation 8.7
|
41.4 mL/hour
Standard Deviation 17.0
|
14.2 mL/hour
Standard Deviation 6.8
|
42.8 mL/hour
Standard Deviation 14.0
|
45.5 mL/hour
Standard Deviation 17.5
|
—
|
—
|
Adverse Events
TAK-063 3 mg (Schizophrenia Participants)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
TAK-063 10 mg (Schizophrenia Participants)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
TAK-063 20 mg (Schizophrenia Participants)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
TAK-063 30 mg (Schizophrenia Participants)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
TAK-063 100 mg (Schizophrenia Participants)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Placebo (Schizophrenia Participants)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
TAK-063 3 mg (Healthy Participants)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
TAK-063 10 mg (Healthy Participants)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
TAK-063 20 mg (Healthy Participants)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo (Healthy Participants)
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 |
TAK-063 3 mg (Schizophrenia Participants)
n=7 participants at risk
TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 10 mg (Schizophrenia Participants)
n=8 participants at risk
TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 20 mg (Schizophrenia Participants)
n=7 participants at risk
TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 30 mg (Schizophrenia Participants)
n=8 participants at risk
TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 100 mg (Schizophrenia Participants)
n=8 participants at risk
TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
Placebo (Schizophrenia Participants)
n=9 participants at risk
Placebo matching TAK-063, tablets, orally, once daily for 7 days in participants with Schizophrenia.
|
TAK-063 3 mg (Healthy Participants)
n=8 participants at risk
TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
|
TAK-063 10 mg (Healthy Participants)
n=8 participants at risk
TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
|
TAK-063 20 mg (Healthy Participants)
n=8 participants at risk
TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
|
Placebo (Healthy Participants)
n=6 participants at risk
Placebo matching TAK-063, tablets, orally, once daily for 7 days in healthy Japanese participants.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Psychiatric disorders
Psychotic Disorder
|
0.00%
0/7
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Reproductive system and breast disorders
Menopausal Symptoms
|
0.00%
0/7
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/7
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Eye disorders
Vision Blurred
|
0.00%
0/7
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/7
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/7
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/7
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Catheter Site Pain
|
14.3%
1/7
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Feeling Of Body Temperature Change
|
0.00%
0/7
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/7
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/7
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.1%
1/9
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Orthostatic Heart Rate Response Increased
|
0.00%
0/7
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.00%
0/7
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.1%
1/9
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Stiffness
|
0.00%
0/7
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
14.3%
1/7
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Somnolence
|
28.6%
2/7
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
37.5%
3/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
57.1%
4/7
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
4/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
100.0%
8/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
22.2%
2/9
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
37.5%
3/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
4/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
62.5%
5/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
2/6
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Akathisia
|
0.00%
0/7
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
2/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
2/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Extrapyramidal Disorder
|
0.00%
0/7
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
37.5%
3/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
2/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Headache
|
0.00%
0/7
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
2/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Oromandibular Dystonia
|
0.00%
0/7
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
2/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/7
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Dizziness Postural
|
14.3%
1/7
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Dyskinesia
|
0.00%
0/7
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
2/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Dystonia
|
0.00%
0/7
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
28.6%
2/7
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.1%
1/9
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Disturbance In Attention
|
0.00%
0/7
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/7
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
2/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.1%
1/9
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Depression
|
0.00%
0/7
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/7
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
22.2%
2/9
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Throat Irritation
|
0.00%
0/7
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermal Cyst
|
0.00%
0/7
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Exfoliative Rash
|
14.3%
1/7
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/7
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Orthostatic Hypotension
|
0.00%
0/7
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
2/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
2/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/7
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/7
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Vessel Puncture Site Pain
|
0.00%
0/7
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Oral Herpes
|
0.00%
0/7
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Nail Injury
|
0.00%
0/7
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Traumatic Haematoma
|
0.00%
0/7
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/7
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Syncope
|
0.00%
0/7
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/7
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.
- Publication restrictions are in place
Restriction type: OTHER