Trial Outcomes & Findings for Effects of TAK-063 on Preventing Ketamine-Induced Brain Activity Changes as Well as Psychotic-Like Symptoms in Healthy Male Adults (NCT NCT01892189)
NCT ID: NCT01892189
Last Updated: 2026-05-08
Results Overview
Ketamine model was used to enhance the sensitivity to detect an effect of phosphodiesterase 10a (PDE10a) inhibition by TAK-063 by ketamine using neuroimaging battery tests. Ketamine induced robust blood oxygen level-dependent(BOLD) functional magnetic resonance imaging(fMRI) response while maintaining minimal accompanying psychotomimetic symptoms. The regions of interest include:left anterior cingulate cortex,right anterior cingulate cortex,left posterior cingulate cortex,right posterior cingulate cortex,left striatum,right striatum,left amygdala,right amygdala,left substantia nigra,right substantia nigra,left thalamus,right thalamus,left ventrolateral prefrontal cortex,right ventrolateral prefrontal cortex,left dorsolateral prefrontal cortex,right dorsolateral prefrontal cortex,left hippocampus,right hippocampus,left subgenual cingulate/Ba25,right subgenual cingulate/Ba25,left paracingulate gyrus/Ba32, and right paracingulate gyrus/Ba32.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
27 participants
Primary outcome timeframe
Day 1: 4 hours post TAK-063 dose or placebo
Results posted on
2026-05-08
Participant Flow
Participants took part in the study at 1 investigative site in the United States from 27 June 2013 to 28 August 2014.
Healthy male participants were enrolled in this 3 period study and randomized in 1 of 9 administration sequences to receive TAK-063 3 mg, TAK-063 10 mg, TAK-063 30 mg and TAK-063 matching placebo. Due to predicted exposures being higher than likely clinically relevant, the dose of 300 mg was removed and replaced by 10 mg in protocol amendment 3.
Participant milestones
| Measure |
Placebo + TAK-063 3 mg + TAK-063 30 mg
TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
|
TAK-063 3 mg + TAK-063 30 mg + Placebo
TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
|
TAK-063 30 mg + Placebo + TAK-063 3 mg
TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
|
Placebo + TAK-063 3 mg + TAK-063 300 mg/10 mg
TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
|
TAK-063 3 mg + TAK-063 300 mg/10 mg + Placebo
TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
|
TAK-063 300 mg/10 mg + Placebo + TAK-063 3 mg
TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
|
Placebo + TAK-063 30 mg + TAK-063 300 mg/10 mg
TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
|
TAK-063 30 mg + TAK-063 300 mg/10 mg + Placebo
TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
|
TAK-063 300 mg/10 mg + Placebo + TAK-063 30 mg
TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), , tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
|
|---|---|---|---|---|---|---|---|---|---|
|
First Intervention Period (1 Day)
STARTED
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
|
First Intervention Period (1 Day)
COMPLETED
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
|
First Intervention Period (1 Day)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout Period 1 (7 Days)
STARTED
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Washout Period 1 (7 Days)
COMPLETED
|
3
|
3
|
1
|
2
|
3
|
2
|
2
|
3
|
1
|
|
Washout Period 1 (7 Days)
NOT COMPLETED
|
0
|
0
|
2
|
1
|
0
|
1
|
1
|
0
|
2
|
|
Second Intervention Period (1 Day)
STARTED
|
3
|
3
|
1
|
2
|
3
|
2
|
2
|
3
|
1
|
|
Second Intervention Period (1 Day)
COMPLETED
|
3
|
3
|
1
|
2
|
3
|
2
|
2
|
3
|
1
|
|
Second Intervention Period (1 Day)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout Period 2 (7 Days)
STARTED
|
3
|
3
|
1
|
2
|
3
|
2
|
2
|
3
|
1
|
|
Washout Period 2 (7 Days)
COMPLETED
|
3
|
3
|
1
|
2
|
3
|
2
|
2
|
3
|
1
|
|
Washout Period 2 (7 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Third Intervention Period (1 Day)
STARTED
|
3
|
3
|
1
|
2
|
3
|
2
|
2
|
3
|
1
|
|
Third Intervention Period (1 Day)
COMPLETED
|
3
|
3
|
1
|
2
|
3
|
2
|
2
|
3
|
1
|
|
Third Intervention Period (1 Day)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Placebo + TAK-063 3 mg + TAK-063 30 mg
TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
|
TAK-063 3 mg + TAK-063 30 mg + Placebo
TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
|
TAK-063 30 mg + Placebo + TAK-063 3 mg
TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
|
Placebo + TAK-063 3 mg + TAK-063 300 mg/10 mg
TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
|
TAK-063 3 mg + TAK-063 300 mg/10 mg + Placebo
TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
|
TAK-063 300 mg/10 mg + Placebo + TAK-063 3 mg
TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
|
Placebo + TAK-063 30 mg + TAK-063 300 mg/10 mg
TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
|
TAK-063 30 mg + TAK-063 300 mg/10 mg + Placebo
TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
|
TAK-063 300 mg/10 mg + Placebo + TAK-063 30 mg
TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), , tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
|
|---|---|---|---|---|---|---|---|---|---|
|
Washout Period 1 (7 Days)
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Washout Period 1 (7 Days)
Withdrawal by Subject
|
0
|
0
|
2
|
1
|
0
|
0
|
1
|
0
|
1
|
|
Washout Period 1 (7 Days)
Noncompliance, Irritability
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Effects of TAK-063 on Preventing Ketamine-Induced Brain Activity Changes as Well as Psychotic-Like Symptoms in Healthy Male Adults
Baseline characteristics by cohort
| Measure |
Placebo + TAK-063 3 mg + TAK-063 30 mg
n=3 Participants
TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
|
TAK-063 3 mg + TAK-063 30 mg + Placebo
n=3 Participants
TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
|
TAK-063 30 mg + Placebo + TAK-063 3 mg
n=3 Participants
TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
|
Placebo + TAK-063 3 mg + TAK-063 300 mg/10 mg
n=3 Participants
TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
|
TAK-063 3 mg + TAK-063 300 mg/10 mg + Placebo
n=3 Participants
TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
|
TAK-063 300 mg/10 mg + Placebo + TAK-063 3 mg
n=3 Participants
TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
|
Placebo + TAK-063 30 mg + TAK-063 300 mg/10 mg
n=3 Participants
TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
|
TAK-063 30 mg + TAK-063 300 mg/10 mg + Placebo
n=3 Participants
TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
|
TAK-063 300 mg/10 mg + Placebo + TAK-063 30 mg
n=3 Participants
TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), , tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
27.7 years
STANDARD_DEVIATION 3.21 • n=41 Participants
|
28.7 years
STANDARD_DEVIATION 7.64 • n=40 Participants
|
23.7 years
STANDARD_DEVIATION 6.66 • n=81 Participants
|
32.3 years
STANDARD_DEVIATION 5.13 • n=140 Participants
|
23 years
STANDARD_DEVIATION 5.20 • n=451 Participants
|
22.3 years
STANDARD_DEVIATION 3.51 • n=31 Participants
|
27 years
STANDARD_DEVIATION 7.94 • n=28 Participants
|
24.7 years
STANDARD_DEVIATION 2.08 • n=12 Participants
|
23.7 years
STANDARD_DEVIATION 5.69 • n=27 Participants
|
25.9 years
STANDARD_DEVIATION 5.60 • n=24 Participants
|
|
Sex/Gender, Customized
Female
|
0 participants
n=41 Participants
|
0 participants
n=40 Participants
|
0 participants
n=81 Participants
|
0 participants
n=140 Participants
|
0 participants
n=451 Participants
|
0 participants
n=31 Participants
|
0 participants
n=28 Participants
|
0 participants
n=12 Participants
|
0 participants
n=27 Participants
|
0 participants
n=24 Participants
|
|
Sex/Gender, Customized
Male
|
3 participants
n=41 Participants
|
3 participants
n=40 Participants
|
3 participants
n=81 Participants
|
3 participants
n=140 Participants
|
3 participants
n=451 Participants
|
3 participants
n=31 Participants
|
3 participants
n=28 Participants
|
3 participants
n=12 Participants
|
3 participants
n=27 Participants
|
27 participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
0 participants
n=41 Participants
|
0 participants
n=40 Participants
|
0 participants
n=81 Participants
|
0 participants
n=140 Participants
|
0 participants
n=451 Participants
|
0 participants
n=31 Participants
|
1 participants
n=28 Participants
|
0 participants
n=12 Participants
|
0 participants
n=27 Participants
|
1 participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Non Hispanic or Latino
|
3 participants
n=41 Participants
|
3 participants
n=40 Participants
|
3 participants
n=81 Participants
|
3 participants
n=140 Participants
|
3 participants
n=451 Participants
|
3 participants
n=31 Participants
|
2 participants
n=28 Participants
|
3 participants
n=12 Participants
|
3 participants
n=27 Participants
|
26 participants
n=24 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 participants
n=41 Participants
|
0 participants
n=40 Participants
|
0 participants
n=81 Participants
|
0 participants
n=140 Participants
|
1 participants
n=451 Participants
|
0 participants
n=31 Participants
|
0 participants
n=28 Participants
|
0 participants
n=12 Participants
|
0 participants
n=27 Participants
|
1 participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=41 Participants
|
0 participants
n=40 Participants
|
0 participants
n=81 Participants
|
0 participants
n=140 Participants
|
0 participants
n=451 Participants
|
0 participants
n=31 Participants
|
1 participants
n=28 Participants
|
0 participants
n=12 Participants
|
0 participants
n=27 Participants
|
1 participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Multiracial
|
0 participants
n=41 Participants
|
0 participants
n=40 Participants
|
0 participants
n=81 Participants
|
0 participants
n=140 Participants
|
0 participants
n=451 Participants
|
0 participants
n=31 Participants
|
0 participants
n=28 Participants
|
1 participants
n=12 Participants
|
0 participants
n=27 Participants
|
1 participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Pacific Islander-White
|
3 participants
n=41 Participants
|
3 participants
n=40 Participants
|
3 participants
n=81 Participants
|
3 participants
n=140 Participants
|
2 participants
n=451 Participants
|
3 participants
n=31 Participants
|
2 participants
n=28 Participants
|
2 participants
n=12 Participants
|
3 participants
n=27 Participants
|
24 participants
n=24 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=41 Participants
|
3 participants
n=40 Participants
|
3 participants
n=81 Participants
|
3 participants
n=140 Participants
|
3 participants
n=451 Participants
|
3 participants
n=31 Participants
|
3 participants
n=28 Participants
|
3 participants
n=12 Participants
|
3 participants
n=27 Participants
|
27 participants
n=24 Participants
|
|
Height
|
179 centimeters (cm)
STANDARD_DEVIATION 2.65 • n=41 Participants
|
182 centimeters (cm)
STANDARD_DEVIATION 4.58 • n=40 Participants
|
177 centimeters (cm)
STANDARD_DEVIATION 8.19 • n=81 Participants
|
187.7 centimeters (cm)
STANDARD_DEVIATION 3.79 • n=140 Participants
|
179.7 centimeters (cm)
STANDARD_DEVIATION 10.79 • n=451 Participants
|
182.3 centimeters (cm)
STANDARD_DEVIATION 3.06 • n=31 Participants
|
183.3 centimeters (cm)
STANDARD_DEVIATION 8.14 • n=28 Participants
|
183.3 centimeters (cm)
STANDARD_DEVIATION 6.51 • n=12 Participants
|
182.7 centimeters (cm)
STANDARD_DEVIATION 4.51 • n=27 Participants
|
181.9 centimeters (cm)
STANDARD_DEVIATION 6.06 • n=24 Participants
|
|
Weight
|
83.23 kilogram (kg)
STANDARD_DEVIATION 11.981 • n=41 Participants
|
93.80 kilogram (kg)
STANDARD_DEVIATION 4.784 • n=40 Participants
|
79.87 kilogram (kg)
STANDARD_DEVIATION 16.910 • n=81 Participants
|
82.3 kilogram (kg)
STANDARD_DEVIATION 12.643 • n=140 Participants
|
87.47 kilogram (kg)
STANDARD_DEVIATION 13.955 • n=451 Participants
|
77.33 kilogram (kg)
STANDARD_DEVIATION 8.107 • n=31 Participants
|
81.10 kilogram (kg)
STANDARD_DEVIATION 5.821 • n=28 Participants
|
86.40 kilogram (kg)
STANDARD_DEVIATION 4.939 • n=12 Participants
|
79.07 kilogram (kg)
STANDARD_DEVIATION 11.716 • n=27 Participants
|
83.40 kilogram (kg)
STANDARD_DEVIATION 10.306 • n=24 Participants
|
|
Body Mass Index
|
26.06 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 4.430 • n=41 Participants
|
28.38 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 2.557 • n=40 Participants
|
25.30 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 3.190 • n=81 Participants
|
23.39 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 3.844 • n=140 Participants
|
26.99 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 2.108 • n=451 Participants
|
23.28 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 2.611 • n=31 Participants
|
24.20 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 2.417 • n=28 Participants
|
25.71 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 1.011 • n=12 Participants
|
23.69 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 3.269 • n=27 Participants
|
25.22 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 2.997 • n=24 Participants
|
|
Smoking Classification
Never smoked
|
3 participants
n=41 Participants
|
2 participants
n=40 Participants
|
3 participants
n=81 Participants
|
2 participants
n=140 Participants
|
3 participants
n=451 Participants
|
3 participants
n=31 Participants
|
2 participants
n=28 Participants
|
3 participants
n=12 Participants
|
2 participants
n=27 Participants
|
23 participants
n=24 Participants
|
|
Smoking Classification
Ex-smoker
|
0 participants
n=41 Participants
|
1 participants
n=40 Participants
|
0 participants
n=81 Participants
|
1 participants
n=140 Participants
|
0 participants
n=451 Participants
|
0 participants
n=31 Participants
|
1 participants
n=28 Participants
|
0 participants
n=12 Participants
|
1 participants
n=27 Participants
|
4 participants
n=24 Participants
|
|
Caffeine Consumption
Consumes Caffiene
|
2 participants
n=41 Participants
|
3 participants
n=40 Participants
|
3 participants
n=81 Participants
|
3 participants
n=140 Participants
|
2 participants
n=451 Participants
|
2 participants
n=31 Participants
|
3 participants
n=28 Participants
|
3 participants
n=12 Participants
|
3 participants
n=27 Participants
|
24 participants
n=24 Participants
|
|
Caffeine Consumption
Not consumes Caffiene
|
1 participants
n=41 Participants
|
0 participants
n=40 Participants
|
0 participants
n=81 Participants
|
0 participants
n=140 Participants
|
1 participants
n=451 Participants
|
1 participants
n=31 Participants
|
0 participants
n=28 Participants
|
0 participants
n=12 Participants
|
0 participants
n=27 Participants
|
3 participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Day 1: 4 hours post TAK-063 dose or placeboPopulation: The pharmacodynamic (PD) analysis set included all participants in the safety set and with at least 1 valid PD assessment. PD analysis set did not include 2 participants treated with TAK-063 300 mg.
Ketamine model was used to enhance the sensitivity to detect an effect of phosphodiesterase 10a (PDE10a) inhibition by TAK-063 by ketamine using neuroimaging battery tests. Ketamine induced robust blood oxygen level-dependent(BOLD) functional magnetic resonance imaging(fMRI) response while maintaining minimal accompanying psychotomimetic symptoms. The regions of interest include:left anterior cingulate cortex,right anterior cingulate cortex,left posterior cingulate cortex,right posterior cingulate cortex,left striatum,right striatum,left amygdala,right amygdala,left substantia nigra,right substantia nigra,left thalamus,right thalamus,left ventrolateral prefrontal cortex,right ventrolateral prefrontal cortex,left dorsolateral prefrontal cortex,right dorsolateral prefrontal cortex,left hippocampus,right hippocampus,left subgenual cingulate/Ba25,right subgenual cingulate/Ba25,left paracingulate gyrus/Ba32, and right paracingulate gyrus/Ba32.
Outcome measures
| Measure |
TAK-063 300 mg
TAK-063 300 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 and 3.
|
TAK-063 10 mg
n=14 Participants
TAK-063 10 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
|
TAK-063 30 mg
n=15 Participants
TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
|
TAK-063 3 mg
n=14 Participants
TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
|
Placebo
n=22 Participants
TAK-063 placebo-matching tablets, orally and ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
|
|---|---|---|---|---|---|
|
Ketamine-Induced Brain Activity in Regions of Interest During Resting State
Right Posterior Cingulate Cortex
|
—
|
0.6132 percent signal change in brain activity
Standard Deviation 0.79296
|
0.3783 percent signal change in brain activity
Standard Deviation 0.55473
|
0.4515 percent signal change in brain activity
Standard Deviation 0.57054
|
0.5412 percent signal change in brain activity
Standard Deviation 0.52336
|
|
Ketamine-Induced Brain Activity in Regions of Interest During Resting State
Right Thalamus
|
—
|
0.5159 percent signal change in brain activity
Standard Deviation 0.44482
|
0.3734 percent signal change in brain activity
Standard Deviation 0.44173
|
0.3392 percent signal change in brain activity
Standard Deviation 0.59598
|
0.4807 percent signal change in brain activity
Standard Deviation 0.35272
|
|
Ketamine-Induced Brain Activity in Regions of Interest During Resting State
Left Anterior Cingulate Cortex
|
—
|
0.4439 percent signal change in brain activity
Standard Deviation 0.72261
|
0.3876 percent signal change in brain activity
Standard Deviation 0.47127
|
0.2943 percent signal change in brain activity
Standard Deviation 0.67925
|
0.4954 percent signal change in brain activity
Standard Deviation 0.53382
|
|
Ketamine-Induced Brain Activity in Regions of Interest During Resting State
Right Anterior Cingulate Cortex
|
—
|
0.4199 percent signal change in brain activity
Standard Deviation 0.70069
|
0.3251 percent signal change in brain activity
Standard Deviation 0.47592
|
0.2542 percent signal change in brain activity
Standard Deviation 0.55542
|
0.4611 percent signal change in brain activity
Standard Deviation 0.44870
|
|
Ketamine-Induced Brain Activity in Regions of Interest During Resting State
Left Posterior Cingulate Cortex
|
—
|
0.5316 percent signal change in brain activity
Standard Deviation 0.77685
|
0.3987 percent signal change in brain activity
Standard Deviation 0.49018
|
0.4647 percent signal change in brain activity
Standard Deviation 0.52746
|
0.4922 percent signal change in brain activity
Standard Deviation 0.52563
|
|
Ketamine-Induced Brain Activity in Regions of Interest During Resting State
Left Striatum
|
—
|
0.3045 percent signal change in brain activity
Standard Deviation 0.51442
|
0.2453 percent signal change in brain activity
Standard Deviation 0.40828
|
0.0644 percent signal change in brain activity
Standard Deviation 0.47601
|
0.2914 percent signal change in brain activity
Standard Deviation 0.40513
|
|
Ketamine-Induced Brain Activity in Regions of Interest During Resting State
Right Striatum
|
—
|
0.3124 percent signal change in brain activity
Standard Deviation 0.46817
|
0.2617 percent signal change in brain activity
Standard Deviation 0.36033
|
0.1154 percent signal change in brain activity
Standard Deviation 0.52174
|
0.3605 percent signal change in brain activity
Standard Deviation 0.37202
|
|
Ketamine-Induced Brain Activity in Regions of Interest During Resting State
Left Amygdala
|
—
|
0.4888 percent signal change in brain activity
Standard Deviation 0.60449
|
0.3435 percent signal change in brain activity
Standard Deviation 0.57560
|
0.4776 percent signal change in brain activity
Standard Deviation 0.72631
|
0.3413 percent signal change in brain activity
Standard Deviation 0.66866
|
|
Ketamine-Induced Brain Activity in Regions of Interest During Resting State
Right Amygdala
|
—
|
0.0106 percent signal change in brain activity
Standard Deviation 0.76838
|
0.2686 percent signal change in brain activity
Standard Deviation 0.53395
|
0.1180 percent signal change in brain activity
Standard Deviation 0.85125
|
0.2102 percent signal change in brain activity
Standard Deviation 0.72431
|
|
Ketamine-Induced Brain Activity in Regions of Interest During Resting State
Left Substantia Nigra
|
—
|
0.5560 percent signal change in brain activity
Standard Deviation 0.67716
|
0.2214 percent signal change in brain activity
Standard Deviation 0.36486
|
0.2857 percent signal change in brain activity
Standard Deviation 0.61851
|
0.3989 percent signal change in brain activity
Standard Deviation 0.49787
|
|
Ketamine-Induced Brain Activity in Regions of Interest During Resting State
Right Substantia Nigra
|
—
|
0.3398 percent signal change in brain activity
Standard Deviation 0.45331
|
0.1148 percent signal change in brain activity
Standard Deviation 0.40258
|
0.2209 percent signal change in brain activity
Standard Deviation 0.69383
|
0.2925 percent signal change in brain activity
Standard Deviation 0.45514
|
|
Ketamine-Induced Brain Activity in Regions of Interest During Resting State
Left Thalamus
|
—
|
0.5564 percent signal change in brain activity
Standard Deviation 0.52695
|
0.3589 percent signal change in brain activity
Standard Deviation 0.43768
|
0.3406 percent signal change in brain activity
Standard Deviation 0.58293
|
0.5166 percent signal change in brain activity
Standard Deviation 0.40051
|
|
Ketamine-Induced Brain Activity in Regions of Interest During Resting State
Left Ventrolateral Prefrontal Cortex
|
—
|
0.6081 percent signal change in brain activity
Standard Deviation 0.73306
|
0.5900 percent signal change in brain activity
Standard Deviation 0.47920
|
0.5183 percent signal change in brain activity
Standard Deviation 0.66695
|
0.6355 percent signal change in brain activity
Standard Deviation 0.79768
|
|
Ketamine-Induced Brain Activity in Regions of Interest During Resting State
Right Ventrolateral Prefrontal Cortex
|
—
|
0.6661 percent signal change in brain activity
Standard Deviation 0.75274
|
0.6119 percent signal change in brain activity
Standard Deviation 0.44821
|
0.5134 percent signal change in brain activity
Standard Deviation 0.69396
|
0.7932 percent signal change in brain activity
Standard Deviation 0.59179
|
|
Ketamine-Induced Brain Activity in Regions of Interest During Resting State
Left Dorsolateral Prefrontal Cortex
|
—
|
0.4451 percent signal change in brain activity
Standard Deviation 0.62506
|
0.3720 percent signal change in brain activity
Standard Deviation 0.30576
|
0.2576 percent signal change in brain activity
Standard Deviation 0.56173
|
0.3918 percent signal change in brain activity
Standard Deviation 0.41983
|
|
Ketamine-Induced Brain Activity in Regions of Interest During Resting State
Right Dorsolateral Prefrontal Cortex
|
—
|
0.5403 percent signal change in brain activity
Standard Deviation 0.78105
|
0.4331 percent signal change in brain activity
Standard Deviation 0.39160
|
0.2799 percent signal change in brain activity
Standard Deviation 0.53268
|
0.4715 percent signal change in brain activity
Standard Deviation 0.40803
|
|
Ketamine-Induced Brain Activity in Regions of Interest During Resting State
Left Hippocampus
|
—
|
0.3073 percent signal change in brain activity
Standard Deviation 0.41116
|
0.2123 percent signal change in brain activity
Standard Deviation 0.35146
|
0.1790 percent signal change in brain activity
Standard Deviation 0.47311
|
0.3150 percent signal change in brain activity
Standard Deviation 0.37531
|
|
Ketamine-Induced Brain Activity in Regions of Interest During Resting State
Right Hippocampus
|
—
|
0.2141 percent signal change in brain activity
Standard Deviation 0.34537
|
0.0989 percent signal change in brain activity
Standard Deviation 0.35725
|
0.1814 percent signal change in brain activity
Standard Deviation 0.51038
|
0.2540 percent signal change in brain activity
Standard Deviation 0.27489
|
|
Ketamine-Induced Brain Activity in Regions of Interest During Resting State
Left Subgenual Cingulate/BA25
|
—
|
-0.2448 percent signal change in brain activity
Standard Deviation 1.46965
|
-0.0002 percent signal change in brain activity
Standard Deviation 2.18015
|
0.2236 percent signal change in brain activity
Standard Deviation 1.22450
|
-0.3974 percent signal change in brain activity
Standard Deviation 1.60367
|
|
Ketamine-Induced Brain Activity in Regions of Interest During Resting State
Right Subgenual Cingulate/BA25
|
—
|
-0.6379 percent signal change in brain activity
Standard Deviation 2.30349
|
0.0424 percent signal change in brain activity
Standard Deviation 1.71727
|
-0.3430 percent signal change in brain activity
Standard Deviation 1.15319
|
-0.1463 percent signal change in brain activity
Standard Deviation 1.55680
|
|
Ketamine-Induced Brain Activity in Regions of Interest During Resting State
Left Paracingulate Gyrus/BA32
|
—
|
0.4069 percent signal change in brain activity
Standard Deviation 0.65537
|
0.3281 percent signal change in brain activity
Standard Deviation 0.38990
|
0.2799 percent signal change in brain activity
Standard Deviation 0.59577
|
0.4776 percent signal change in brain activity
Standard Deviation 0.43067
|
|
Ketamine-Induced Brain Activity in Regions of Interest During Resting State
Right Paracingulate Gyrus/BA32
|
—
|
0.4972 percent signal change in brain activity
Standard Deviation 0.82842
|
0.3969 percent signal change in brain activity
Standard Deviation 0.52267
|
0.3583 percent signal change in brain activity
Standard Deviation 0.58987
|
0.5849 percent signal change in brain activity
Standard Deviation 0.51897
|
SECONDARY outcome
Timeframe: Day 1: pre-dose and at multiple time points (up to 24 hours) postdosePopulation: The pharmacokinetic (PK) analysis set included all participants in the safety set and with at least 1 measurable plasma concentration. PK analysis set did not include 2 participants treated with 300 mg.
Outcome measures
| Measure |
TAK-063 300 mg
TAK-063 300 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 and 3.
|
TAK-063 10 mg
n=15 Participants
TAK-063 10 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
|
TAK-063 30 mg
TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
|
TAK-063 3 mg
n=14 Participants
TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
|
Placebo
n=14 Participants
TAK-063 placebo-matching tablets, orally and ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
|
|---|---|---|---|---|---|
|
Cmax: Maximum Observed Plasma Concentration for TAK-063 and TAK-063 Metabolite (M-I)
TAK-063
|
—
|
109.9 nanogram per milliliter (ng/mL)
Standard Deviation 27.053
|
—
|
48.16 nanogram per milliliter (ng/mL)
Standard Deviation 8.769
|
10.35 nanogram per milliliter (ng/mL)
Standard Deviation 2.860 • Interval 0.5 to 6.0
|
|
Cmax: Maximum Observed Plasma Concentration for TAK-063 and TAK-063 Metabolite (M-I)
M-I
|
—
|
103.72 nanogram per milliliter (ng/mL)
Standard Deviation 32.635
|
—
|
48.94 nanogram per milliliter (ng/mL)
Standard Deviation 11.500
|
12.07 nanogram per milliliter (ng/mL)
Standard Deviation 3.235
|
SECONDARY outcome
Timeframe: Day 1: pre-dose and at multiple time points (up to 24 hours) postdosePopulation: The PK analysis set included all participants in the safety set and with at least 1 measurable plasma concentration. PK analysis set did not include 2 participants treated with 300 mg.
Outcome measures
| Measure |
TAK-063 300 mg
TAK-063 300 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 and 3.
|
TAK-063 10 mg
n=15 Participants
TAK-063 10 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
|
TAK-063 30 mg
TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
|
TAK-063 3 mg
n=14 Participants
TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
|
Placebo
n=14 Participants
TAK-063 placebo-matching tablets, orally and ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
|
|---|---|---|---|---|---|
|
Tmax: Time to Reach Cmax for TAK-063 and TAK-063 M-I
TAK-063
|
—
|
3.02 hours
Interval 2.0 to 5.8
|
—
|
3.03 hours
Interval 2.0 to 5.8
|
3.02 hours
Full Range 2.860 • Interval 0.5 to 6.0
|
|
Tmax: Time to Reach Cmax for TAK-063 and TAK-063 M-I
M-I
|
—
|
4.23 hours
Interval 2.0 to 6.0
|
—
|
3.03 hours
Interval 2.0 to 5.7
|
2.96 hours
Interval 1.9 to 4.3
|
SECONDARY outcome
Timeframe: Day 1: Pre-dose and at multiple time points (up to 24 hours) post-dosePopulation: The PK analysis set included all participants in the safety set and with at least 1 measurable plasma concentration. PK analysis set did not include 2 participants treated with 300 mg.
Outcome measures
| Measure |
TAK-063 300 mg
TAK-063 300 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 and 3.
|
TAK-063 10 mg
n=15 Participants
TAK-063 10 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
|
TAK-063 30 mg
TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
|
TAK-063 3 mg
n=14 Participants
TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
|
Placebo
n=14 Participants
TAK-063 placebo-matching tablets, orally and ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
|
|---|---|---|---|---|---|
|
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 M-I
M-I
|
—
|
1285.18 nanogram hours per milliliter (ng*hr/mL)
Standard Deviation 499.431
|
—
|
582.91 nanogram hours per milliliter (ng*hr/mL)
Standard Deviation 201.503
|
114.81 nanogram hours per milliliter (ng*hr/mL)
Standard Deviation 48.453
|
|
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 M-I
TAK-063
|
—
|
1298.89 nanogram hours per milliliter (ng*hr/mL)
Standard Deviation 331.095
|
—
|
548.58 nanogram hours per milliliter (ng*hr/mL)
Standard Deviation 122.686
|
111.36 nanogram hours per milliliter (ng*hr/mL)
Standard Deviation 38.460
|
SECONDARY outcome
Timeframe: Baseline up to 14 days after last dose of study drug (Day 32)Population: Safety analysis set included all participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
TAK-063 300 mg
n=2 Participants
TAK-063 300 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 and 3.
|
TAK-063 10 mg
n=14 Participants
TAK-063 10 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
|
TAK-063 30 mg
n=15 Participants
TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
|
TAK-063 3 mg
n=14 Participants
TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
|
Placebo
n=22 Participants
TAK-063 placebo-matching tablets, orally and ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)
|
100 percentage of participants
|
57.1 percentage of participants
|
86.7 percentage of participants
|
50 percentage of participants
|
68.2 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to 14 days after last dose of study drug (Day 32)Population: Safety analysis set included all participants who received at least 1 dose of study drug.
The percentage of participants with any markedly abnormal standard safety laboratory values collected throughout study.
Outcome measures
| Measure |
TAK-063 300 mg
n=2 Participants
TAK-063 300 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 and 3.
|
TAK-063 10 mg
n=14 Participants
TAK-063 10 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
|
TAK-063 30 mg
n=15 Participants
TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
|
TAK-063 3 mg
n=14 Participants
TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
|
Placebo
n=22 Participants
TAK-063 placebo-matching tablets, orally and ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Meet the Takeda Global Research and Development Center, Inc. (TGRD) Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose
|
0 percentage of participants
|
14.3 percentage of participants
|
6.7 percentage of participants
|
0 percentage of participants
|
9.1 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to 14 days after last dose of study drug (Day 32)Population: Safety analysis set included all participants who received at least 1 dose of study drug.
The percentage of participants who meet markedly abnormal criteria designated by TGRD. Vital signs included oral temperature, respiration, blood pressure and pulse (beats per minute).
Outcome measures
| Measure |
TAK-063 300 mg
n=2 Participants
TAK-063 300 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 and 3.
|
TAK-063 10 mg
n=14 Participants
TAK-063 10 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
|
TAK-063 30 mg
n=15 Participants
TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
|
TAK-063 3 mg
n=14 Participants
TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
|
Placebo
n=22 Participants
TAK-063 placebo-matching tablets, orally and ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Meet the TGRD Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose
|
100 percentage of participants
|
57.1 percentage of participants
|
53.3 percentage of participants
|
64.3 percentage of participants
|
50.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to 14 days after last dose of study drug (Day 32)Population: Safety analysis set included all participants who received at least 1 dose of study drug.
The percentage of participants who meet markedly abnormal criteria designated by TGRD measured throughout study.
Outcome measures
| Measure |
TAK-063 300 mg
n=2 Participants
TAK-063 300 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 and 3.
|
TAK-063 10 mg
n=14 Participants
TAK-063 10 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
|
TAK-063 30 mg
n=15 Participants
TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
|
TAK-063 3 mg
n=14 Participants
TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
|
Placebo
n=22 Participants
TAK-063 placebo-matching tablets, orally and ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Meet the TGRD Markedly Abnormal Criteria for Safety Electrocardiogram (ECG) Parameters at Least Once Post Dose
|
100 percentage of participants
|
35.7 percentage of participants
|
53.3 percentage of participants
|
14.3 percentage of participants
|
27.3 percentage of participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
TAK-063 3 mg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
TAK-063 10 mg
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
TAK-063 30 mg
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
TAK-063 300 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=22 participants at risk
TAK-063 placebo-matching tablets, orally and ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
|
TAK-063 3 mg
n=14 participants at risk
TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
|
TAK-063 10 mg
n=14 participants at risk
TAK-063 10 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
|
TAK-063 30 mg
n=15 participants at risk
TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
|
TAK-063 300 mg
n=2 participants at risk
TAK-063 300 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 and 3.
|
|---|---|---|---|---|---|
|
Eye disorders
Diplopia
|
0.00%
0/22 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/14 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/14 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and 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
|
45.5%
10/22 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
21.4%
3/14 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
42.9%
6/14 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
53.3%
8/15 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and 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%
1/2 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and 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
|
27.3%
6/22 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and 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%
2/14 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
21.4%
3/14 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
13.3%
2/15 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and 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
Dry Mouth
|
0.00%
0/22 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
1/14 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/14 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and 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
Retching
|
9.1%
2/22 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/14 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/14 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and 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
Fatigue
|
13.6%
3/22 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
1/14 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and 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%
4/14 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/22 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/14 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
1/14 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and 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
Pharyngitis
|
4.5%
1/22 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/14 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/14 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and 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
Back Pain
|
0.00%
0/22 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/14 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/14 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and 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
Muscle Tightness
|
0.00%
0/22 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/14 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/14 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and 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%
1/2 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and 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
|
9.1%
2/22 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
1/14 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and 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%
4/14 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
46.7%
7/15 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and 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%
1/2 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and 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
|
4.5%
1/22 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and 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%
2/14 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
1/14 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and 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
|
4.5%
1/22 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/14 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/14 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
13.3%
2/15 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and 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
Dysarthria
|
0.00%
0/22 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
1/14 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
1/14 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and 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
Lethargy
|
0.00%
0/22 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/14 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
1/14 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and 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
Paraesthesia
|
0.00%
0/22 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/14 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/14 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and 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
Coordination Abnormal
|
4.5%
1/22 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/14 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/14 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and 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
Hypoaesthesia
|
4.5%
1/22 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/14 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/14 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and 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
|
4.5%
1/22 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/14 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/14 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and 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
Disorientation
|
4.5%
1/22 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and 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%
2/14 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
1/14 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/22 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/14 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/14 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and 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%
1/2 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and 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
Communication Disorder
|
0.00%
0/22 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
1/14 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/14 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and 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
Confusional State
|
0.00%
0/22 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
1/14 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/14 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/22 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
1/14 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/14 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/15 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and 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
Pallor
|
0.00%
0/22 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
1/14 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
21.4%
3/14 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
13.3%
2/15 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and 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
Hot Flush
|
4.5%
1/22 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/14 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
1/14 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and 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
Hypotension
|
0.00%
0/22 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/14 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/14 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.7%
1/15 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • Baseline up to 14 days after last dose of study drug (Day 32)
At each visit the investigator had to document any occurrence of adverse events and 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
Medical Director
Takeda (Note: This product was divested to Axsome in 2026)
Phone: +1-877-825-3327
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee No publication related to study results will be made without Sponsor's prior written approval. Any proposed publication or presentation will be submitted to Sponsor for review 60 days in advance of publication. Institution will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for an additional 60 days to preserve intellectual property
- Publication restrictions are in place
Restriction type: OTHER