Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TAK-063 · 3 trials · 3 indications
PANSS assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210; higher score indicates greater severity. Least square mean and standard error values were determined using a mixed model for repeated measures (MMRM). A negative change from Baseline indicates improvement.
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.
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
The percentage of participants with any markedly abnormal standard safety laboratory values, including hematology, serum chemistries, and urinalysis, during the treatment period.
The percentage of participants who meet markedly abnormal criteria for vital signs, including oral body temperature, respiration rate, pulse, and resting blood pressure and after standing
The percentage of participants who meet markedly abnormal criteria specified by the protocol and statistical analysis plan during the treatment period.
| Arm | Type | Description |
|---|---|---|
| TAK-063 20 mg | EXPERIMENTAL | TAK-063 20 mg, tablets, orally, once daily for up to 6 weeks. Dose may be titrated down to 10 mg/day, if intolerable. |
| Placebo | PLACEBO_COMPARATOR | TAK-063 matching-placebo tablets, orally, once daily for up to 6 weeks. |
| Sequence 1: Placebo + TAK-063 3 mg + TAK-063 30 mg | EXPERIMENTAL | Period 1, Day 1: TAK-063 placebo-matching tablets, orally, single dose and ketamine, intravenous administration according to a bolus infusion adjusted to the participant's weight; Period 2, Day 1: TAK-063 3 milligram (mg), orally, single dose and ketamine, intravenous administration according to a bolus infusion adjusted to the participant's weight; Period 3, Day 1: TAK-063 30 mg tablets, orally, single dose and ketamine, intravenous administration according to a bolus infusion adjusted to the participant's weight. Period 1 \& 2 are followed by 7 day washout period. |
| Sequence 2: TAK-063 3 mg + TAK-063 30 mg + Placebo | EXPERIMENTAL | Period 1, Day 1: TAK-063 3 mg tablets, orally, single dose and ketamine, intravenous administration according to a bolus infusion adjusted to the participant's weight; Period 2, Day 1: TAK-063 30 mg tablets, orally, single dose and ketamine, intravenous administration according to a bolus infusion adjusted to the participant's weight; Period 3, Day 1: TAK-063 placebo-matching tablets, orally, single dose and ketamine, intravenous administration according to a bolus infusion adjusted to the participant's weight. Period 1 \& 2 are followed by 7 day washout period. |
| Sequence 3: TAK-063 30 mg + Placebo + TAK-063 3 mg | EXPERIMENTAL | Period 1, Day 1: TAK-063 30 mg tablets, orally, single dose and ketamine, intravenous administration according to a bolus infusion adjusted to the participant's weight; Period 2, Day 1: TAK-063 placebo-matching tablets, orally, single dose and ketamine, intravenous administration according to a bolus infusion adjusted to the participant's weight; Period 3, Day 1: TAK-063 3 mg tablets, orally, single dose and ketamine, intravenous administration according to a bolus infusion adjusted to the participant's weight. Period 1 \& 2 are followed by 7 day washout period. |
| Sequence 4: Placebo + TAK-063 3 mg + TAK-063 300 mg | EXPERIMENTAL | Period 1, Day 1: TAK-063 placebo-matching tablets, orally, single dose and ketamine, intravenous administration according to a bolus infusion adjusted to the participant's weight; Period 2, Day 1: TAK-063 3 mg tablets, orally, single dose and ketamine, intravenous administration according to a bolus infusion adjusted to the participant's weight; Period 3, Day 1: TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), tablets, orally, single dose and ketamine, intravenous administration according to a bolus infusion adjusted to the participant's weight. Period 1 \& 2 are followed by 7 day washout period. |
| Sequence 5: TAK-063 3 mg + TAK-063 300 mg+ Placebo | EXPERIMENTAL | Period 1, Day 1: TAK-063 3 mg tablets, orally, single dose and ketamine, intravenous administration according to a bolus infusion adjusted to the participant's weight; Period 2, Day 1: TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), tablets, orally, single dose and ketamine, intravenous administration according to a bolus infusion adjusted to the participant's weight; Period 3, Day 1: TAK-063 placebo-matching tablets, orally, single dose and ketamine, intravenous administration according to a bolus infusion adjusted to the participant's weight. Period 1 \& 2 are followed by 7 day washout period |
| Sequence 6: TAK-063 300 mg + Placebo + TAK-063 3 mg | EXPERIMENTAL | Period 1, Day 1: TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), tablets, orally, single dose and ketamine, intravenous administration according to a bolus infusion adjusted to the participant's weight; Period 2, Day 1: TAK-063 placebo-matching tablets, orally, single dose and ketamine, intravenous administration according to a bolus infusion adjusted to the participant's weight; Period 3, Day 1: TAK-063 3 mg tablets, orally, single dose and ketamine, intravenous administration according to a bolus infusion adjusted to the participant's weight. Period 1 \& 2 are followed by 7 day washout period. |
| Sequence 7: Placebo + TAK-063 30 mg + TAK-063 300 mg | EXPERIMENTAL | Period 1, Day 1: TAK-063 placebo-matching tablets, orally, single dose and ketamine, intravenous administration according to a bolus infusion adjusted to the participant's weight: Period 2, Day 1: TAK-063 30 mg tablets, orally, single dose and ketamine, intravenous administration according to a bolus infusion adjusted to the participant's weight; Period 3, Day 1: TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), tablets, orally, single dose and ketamine, intravenous administration according to a bolus infusion adjusted to the participant's weight. Period 1 \& 2 are followed by 7 day washout period |
| Sequence 8: TAK-063 30 mg + TAK-063 300 mg + Placebo | EXPERIMENTAL | Period 1, Day 1: TAK-063 30 mg tablets, orally, single dose and ketamine, intravenous administration according to a bolus infusion adjusted to the participant's weight; Period 2, Day 1: TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), tablets, orally, single dose and ketamine, intravenous administration according to a bolus infusion adjusted to the participant's weight; Period 3, Day 1: TAK-063 placebo-matching tablets, orally, single dose and ketamine, intravenous administration according to a bolus infusion adjusted to the participant's weight. Period 1 \& 2 are followed by 7 day washout period. |
| Sequence 9: TAK-063 300 mg + Placebo + TAK-063 30 mg | EXPERIMENTAL | Period 1, Day 1: TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), tablets, orally, single dose and ketamine, intravenous administration according to a bolus infusion adjusted to the participant's weight; Period 2, Day 1: TAK-063 placebo-matching tablets, orally, single dose and ketamine, intravenous administration according to a bolus infusion adjusted to the participant's weight; Period 3, Day 1: TAK-063 30 mg tablets, orally, single dose and ketamine, intravenous administration according to a bolus infusion adjusted to the participant's weight. Period 1 \& 2 are followed by 7 day washout period |
| TAK-063 3 mg | EXPERIMENTAL | TAK-063 3 mg, tablets, orally, once daily for 7 days. |
| TAK-063 10 mg | EXPERIMENTAL | TAK-063 10 mg, tablets, orally, once daily for 7 days. |
| TAK-063 30 mg | EXPERIMENTAL | TAK-063 30 mg, tablets, orally, once daily for 7 days. |
| TAK-063 100 mg | EXPERIMENTAL | TAK-063 100 mg, tablets, orally, once daily for 7 days. |
| Name | Type | Description |
|---|---|---|
| TAK-063 20 mg | DRUG | TAK-063 tablet. |
| Placebo | DRUG | TAK-063 matching-placebo tablet. |
| Ketamine | DRUG | Ketamine intravenous administration. |
| TAK-063 | DRUG | TAK-063 tablets |
| TAK-063 Placebo | DRUG | TAK-063 placebo-matching tablets |
Inclusion Criteria: 1. Is capable of understanding and complying with protocol requirements. 2. The participants or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation o...
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TAK-063 is an investigational small molecule developed by Takeda Pharmaceutical Company Limited for psychiatric conditions. It has been studied in schizophrenia and in ketamine-induced brain activity changes with psychotic-like symptoms. TAK-063 is not approved and remains in clinical development, with completed Phase 1 and Phase 2 trials.
TAK-063 was studied as a treatment for schizophrenia, including an acute exacerbation of the condition. A completed Phase 2 trial, NCT02477020, evaluated efficacy and safety in 164 participants with acute schizophrenia in the United States. TAK-063 is investigational and has not been approved for schizophrenia or any other indication.
TAK-063 is developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda sponsored the clinical program evaluating the compound in schizophrenia and in ketamine-induced brain activity changes. The drug remains an investigational asset within Takeda's psychiatry pipeline.
TAK-063 is in Phase 1 development, with completed Phase 1 and Phase 2 studies in its clinical program. The Phase 2 trial NCT02477020 tested TAK-063 in acute schizophrenia, while Phase 1 trials NCT01892189 and NCT01879722 evaluated ketamine-induced brain activity changes and multiple rising doses. TAK-063 is investigational and not approved.
TAK-063 has been evaluated in completed trials including NCT02477020, a Phase 2 study in 164 participants with acute schizophrenia, NCT01892189, a Phase 1 study in 27 healthy male adults examining ketamine-induced brain activity changes, and NCT01879722, a Phase 1 multiple rising dose study in 77 participants.