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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1139-5355 | Other Identifier | World Health Organization |
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The purpose of this study is to characterize the safety and tolerability of TAK-063 when administered as multiple oral doses at escalating dose levels in participants with stable schizophrenia and in healthy Japanese participants.
The drug being tested in this study is called TAK-063. TAK-063 is being tested to find a well-tolerated dose and also to treat schizophrenia. This study will look at how well different doses of TAK-063 are tolerated in healthy people of Japanese descent and in people with stable schizophrenia.
Five dose levels will be examined, starting at the lowest, in each population with 10 participants in each dose level. These participants will be randomized to receive TAK-063 (8 subjects) and placebo (2 subjects) once daily (QD) for 7 days.
In total, approximately 60 participants will be enrolled in the study. This trial will be conducted in single site in the United States. The overall time to participate in this study is up to 42 days. Participants will make 2 visits to the clinic, including 8-10 days confinement to the clinic, and will be contacted by telephone 7 days after last dose of study drug for a follow-up assessment.
Dose escalation and the actual choice of the subsequent dose level will only occur following a review of the blinded data from the previous cohorts.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 20 mg | Experimental | TAK-063 20 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. |
|
| Placebo | Placebo Comparator | Placebo matching TAK-063, tablets, orally, once daily for 7 days. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAK-063 | Drug | TAK-063 tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Experience at Least One Treatment-Emergent Adverse Event (TEAE) After 7 Days of Dosing | 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. | Day 1 to Day 14 |
| Percentage of Participants With Markedly Abnormal Safety Laboratory Tests | The percentage of participants with any markedly abnormal standard safety laboratory values, including hematology, serum chemistries, and urinalysis, during the treatment period. | Day 1 to Day 8 |
| Percentage of Participants With Markedly Abnormal Vital Sign Measurements | 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 | Day 1 to Day 8 |
| Percentage of Participants With Markedly Abnormal Values of 12-Lead Electrocardiogram (ECG) Parameters | The percentage of participants who meet markedly abnormal criteria specified by the protocol and statistical analysis plan during the treatment period. | Day 1 to Day 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax: Maximum Observed Plasma Concentration for TAK-063 and TAK-063 Metabolite M-I | Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. | Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours) |
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Inclusion Criteria:
Healthy Participants:
Participants with Stable Schizophrenia:
Exclusion Criteria:
All Participants:
Healthy Participants:
Participants with Stable Schizophrenia:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Takeda Global Research & Development Center, Inc. (Note: This product was divested to Axsome in 2026) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Glendale | California | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29103081 | Derived | Goldsmith P, Affinito J, McCue M, Tsai M, Roepcke S, Xie J, Gertsik L, Macek TA. A Randomized Multiple Dose Pharmacokinetic Study of a Novel PDE10A Inhibitor TAK-063 in Subjects with Stable Schizophrenia and Japanese Subjects and Modeling of Exposure Relationships to Adverse Events. Drugs R D. 2017 Dec;17(4):631-643. doi: 10.1007/s40268-017-0214-8. |
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Participants with a diagnosis of Schizophrenia were enrolled into 1 of 6 treatment groups, once a day placebo, 3 mg, 10 mg, 20 mg, 30 mg or 100 mg TAK-063. Healthy Japanese participants were enrolled in 1 of 4 treatment groups, once a day placebo, 3 mg, 10 mg or 20 mg TAK-063.
Participants took part in the study at 1 investigative site in the United States from 21 June 2013 (First participant signed consent) to 23 June 2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | TAK-063 3 mg (Schizophrenia Participants) | TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia. |
| FG001 | TAK-063 10 mg (Schizophrenia Participants) | TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia. |
| FG002 | TAK-063 20 mg (Schizophrenia Participants) | TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia. |
| FG003 | TAK-063 30 mg (Schizophrenia Participants) | TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia. |
| FG004 | TAK-063 100 mg (Schizophrenia Participants) | TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia. |
| FG005 | Placebo (Schizophrenia Participants) | Placebo matching TAK-063, tablets, orally, once daily for 7 days in participants with Schizophrenia. |
| FG006 | TAK-063 3 mg (Healthy Participants) | TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants. |
| FG007 | TAK-063 10 mg (Healthy Participants) | TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants. |
| FG008 | TAK-063 20 mg (Healthy Participants) | TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants. |
| FG009 | Placebo (Healthy Participants) | Placebo matching TAK-063, tablets, orally, once daily for 7 days in healthy Japanese participants. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | TAK-063 3 mg (Schizophrenia Participants) | TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia |
| BG001 | TAK-063 10 mg (Schizophrenia Participants) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Who Experience at Least One Treatment-Emergent Adverse Event (TEAE) After 7 Days of Dosing | 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. | Safety population included all randomized participants who received at least one dose of study drug. | Posted | Number | percentage of participants | Day 1 to Day 14 |
|
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At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TAK-063 3 mg (Schizophrenia Participants) | TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA version 17.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director, Clinical Science | Takeda (Note: This product was divested to Axsome in 2026) | +1-877-825-3327 | clinicaltrialregistry@tpna.com |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000594749 | 1-(2-fluoro-4-(1H-pyrazol-1-yl)phenyl)-5-methoxy-3-(1-phenyl-1H-pyrazol-5-yl)pyridazin-4(1H)-one |
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| TAK-063 Placebo | Drug | TAK-063 placebo-matching tablets |
|
| Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-063 and TAK-063 Metabolite M-I |
Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax. |
| Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours) |
| AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-063 and TAK-063 Metabolite M-I | AUC(0-tlqc) is a measure of total plasma exposure to the drug from time 0 to time of the Last Quantifiable Concentration. | Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours) |
| AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Postdose for TAK-063 and TAK-063 Metabolite M-I | AUC(0-24) is a measure of total plasma exposure to the drug from Time 0 to 24 hours post-dose. | Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours) |
| CL/F: Oral Clearance of TAK-063 | CL/F is apparent clearance of the drug from the plasma, calculated as the drug dose divided by area under the curve from time 0 to 24 hours post-dose, after multiple dosing (at steady state). | Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours) |
| Average Plasma Concentration on Day 1 (Cav) and Day 7 (Cavss) for TAK-063 and TAK-063 Metabolite M-I | Cav is the Average plasma concentration on Day 1, calculated as AUC(0-24)/24 on Day 1. Cavss is the average plasma concentration on Day 7, calculated as AUC(0-24)/24 on Day 7. | Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours) |
| Cmax Molar Ratio: Ratio of TAK-063 Metabolite Cmax to TAK-063 Cmax | Cmax Molar Ratio is the ratio of Cmax molar values of the metabolite compared to the parent calculated by dividing Cmax molar values of metabolite M-I with those of TAK-063. | Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours) |
| AUC(0-24) Ratio: Ratio of TAK-063 Metabolite AUC(0-24) to TAK-063 AUC(0-24) | AUC(0-24) Ratio is the ratio of AUC(0-24) values of the metabolite compared to the parent calculated by dividing AUC(0-24) values of metabolite M-I with those of the parent drug TAK-063. | Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours) |
| Accumulation Ratios Between Day 7 AUC(0-24) and Day 1 AUC(0-24) | Accumulation ratios between Day 7 AUC(0-24) and Day 1 AUC(0-24), (Day 7/Day 1). Estimated Ratio (Day 7/Day 1) is the exponentiated results of the difference between Day 7 and Day 1 in log-transformed values which resolves to the ratio of Day 7/Day 1 estimates. | Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours) |
| Ae(0-24): Total Amount Excreted in the Urine From Time 0 to 24 Hours Postdose for TAK-063 and TAK-063 Metabolite M-I | Ae(0-24) is a measure of the total amount of study drug excreted in the urine from time 0 to 24 hours postdose. | Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours) |
| Fe: Fraction of Drug Excreted in Urine for TAK-063 | Fe is a measure of the fraction of drug excreted in urine and is calculated as Fe = (total amount excreted in the urine from time 0 to 24 hours post-dose / dose)×100 | Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours) |
| CLr: Renal Clearance of TAK-063 and TAK-063 Metabolite M-I | CLr is a measure of apparent clearance of the drug from the urine calculated as total amount excreted in the urine from time 0 to 24 hours postdose / plasma area under the curve from time 0 to 24 hours post-dose. | Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours) |
| Voluntary Withdrawal |
|
TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
| BG002 | TAK-063 20 mg (Schizophrenia Participants) | TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia. |
| BG003 | TAK-063 30 mg (Schizophrenia Participants) | TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia. |
| BG004 | TAK-063 100 mg (Schizophrenia Participants) | TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia. |
| BG005 | Placebo (Schizophrenia Participants) | Placebo matching TAK-063, tablets, orally, once daily for 7 days in participants with Schizophrenia. |
| BG006 | TAK-063 3 mg (Healthy Participants) | TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants. |
| BG007 | TAK-063 10 mg (Healthy Participants) | TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants. |
| BG008 | TAK-063 20 mg (Healthy Participants) | TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants. |
| BG009 | Placebo (Healthy Participants) | Placebo matching TAK-063, tablets, orally, once daily for 7 days in healthy Japanese participants. |
| BG010 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Height | Mean | Standard Deviation | cm |
|
| Weight | Mean | Standard Deviation | kg |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Caffeine Consumption | Number | participants |
|
| Smoking Classification | Number | participants |
|
TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
| OG001 | TAK-063 10 mg (Schizophrenia Participants) | TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia. |
| OG002 | TAK-063 20 mg (Schizophrenia Participants) | TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia. |
| OG003 | TAK-063 30 mg (Schizophrenia Participants) | TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia. |
| OG004 | TAK-063 100 mg (Schizophrenia Participants) | TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia. |
| OG005 | Placebo (Schizophrenia Participants) | Placebo matching TAK-063, tablets, orally, once daily for 7 days in participants with Schizophrenia. |
| OG006 | TAK-063 3 mg (Healthy Participants) | TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants. |
| OG007 | TAK-063 10 mg (Healthy Participants) | TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants. |
| OG008 | TAK-063 20 mg (Healthy Participants) | TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants. |
| OG009 | Placebo (Healthy Participants) | Placebo matching TAK-063, tablets, orally, once daily for 7 days in healthy Japanese participants. |
|
|
| Primary | Percentage of Participants With Markedly Abnormal Safety Laboratory Tests | The percentage of participants with any markedly abnormal standard safety laboratory values, including hematology, serum chemistries, and urinalysis, during the treatment period. | Safety population included all randomized participants who received at least one dose of study drug. | Posted | Number | percentage of participants | Day 1 to Day 8 |
|
|
|
| Primary | Percentage of Participants With Markedly Abnormal Vital Sign Measurements | 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 | Safety population included all randomized participants who received at least one dose of study drug. | Posted | Number | percentage of participants | Day 1 to Day 8 |
|
|
|
| Primary | Percentage of Participants With Markedly Abnormal Values of 12-Lead Electrocardiogram (ECG) Parameters | The percentage of participants who meet markedly abnormal criteria specified by the protocol and statistical analysis plan during the treatment period. | Safety population included all randomized participants who received at least one dose of study drug. | Posted | Number | percentage of participants | Day 1 to Day 8 |
|
|
|
| Secondary | Cmax: Maximum Observed Plasma Concentration for TAK-063 and TAK-063 Metabolite M-I | Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. | PK Set included all randomized participants who received study drug for whom PK data was available for analysis. | Posted | Mean | Standard Deviation | ng/mL | Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours) |
|
|
|
| Secondary | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-063 and TAK-063 Metabolite M-I | Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax. | PK Set included all randomized participants who received study drug for whom PK data was available for analysis. | Posted | Median | Full Range | hour | Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours) |
|
|
|
| Secondary | AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-063 and TAK-063 Metabolite M-I | AUC(0-tlqc) is a measure of total plasma exposure to the drug from time 0 to time of the Last Quantifiable Concentration. | PK Set included all randomized participants who received study drug for whom PK data was available for analysis. | Posted | Mean | Standard Deviation | ng*hr/mL | Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours) |
|
|
|
| Secondary | AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Postdose for TAK-063 and TAK-063 Metabolite M-I | AUC(0-24) is a measure of total plasma exposure to the drug from Time 0 to 24 hours post-dose. | PK Set included all randomized participants who received study drug for whom PK data was available for analysis. | Posted | Mean | Standard Deviation | ng*hr/mL | Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours) |
|
|
|
| Secondary | CL/F: Oral Clearance of TAK-063 | CL/F is apparent clearance of the drug from the plasma, calculated as the drug dose divided by area under the curve from time 0 to 24 hours post-dose, after multiple dosing (at steady state). | PK Set included all randomized participants who received study drug for whom PK data was available for analysis. | Posted | Mean | Standard Deviation | liter/hour | Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours) |
|
|
|
| Secondary | Average Plasma Concentration on Day 1 (Cav) and Day 7 (Cavss) for TAK-063 and TAK-063 Metabolite M-I | Cav is the Average plasma concentration on Day 1, calculated as AUC(0-24)/24 on Day 1. Cavss is the average plasma concentration on Day 7, calculated as AUC(0-24)/24 on Day 7. | PK Set included all randomized participants for whom PK data was available for analysis. | Posted | Mean | Standard Deviation | ng/mL | Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours) |
|
|
|
| Secondary | Cmax Molar Ratio: Ratio of TAK-063 Metabolite Cmax to TAK-063 Cmax | Cmax Molar Ratio is the ratio of Cmax molar values of the metabolite compared to the parent calculated by dividing Cmax molar values of metabolite M-I with those of TAK-063. | PK Set included all randomized participants who received study drug for whom PK data was available for analysis. | Posted | Mean | Standard Deviation | ratio | Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours) |
|
|
|
| Secondary | AUC(0-24) Ratio: Ratio of TAK-063 Metabolite AUC(0-24) to TAK-063 AUC(0-24) | AUC(0-24) Ratio is the ratio of AUC(0-24) values of the metabolite compared to the parent calculated by dividing AUC(0-24) values of metabolite M-I with those of the parent drug TAK-063. | PK Set included all randomized participants who received study drug for whom PK data was available for analysis. | Posted | Mean | Standard Deviation | ratio | Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours) |
|
|
|
| Secondary | Accumulation Ratios Between Day 7 AUC(0-24) and Day 1 AUC(0-24) | Accumulation ratios between Day 7 AUC(0-24) and Day 1 AUC(0-24), (Day 7/Day 1). Estimated Ratio (Day 7/Day 1) is the exponentiated results of the difference between Day 7 and Day 1 in log-transformed values which resolves to the ratio of Day 7/Day 1 estimates. | PK Set included all randomized participants who received study drug for whom PK data was available for analysis. | Posted | Mean | 90% Confidence Interval | ratio | Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours) |
|
|
|
| Secondary | Ae(0-24): Total Amount Excreted in the Urine From Time 0 to 24 Hours Postdose for TAK-063 and TAK-063 Metabolite M-I | Ae(0-24) is a measure of the total amount of study drug excreted in the urine from time 0 to 24 hours postdose. | PK Set included all randomized participants who received study drug for whom PK data was available for analysis. | Posted | Mean | Standard Deviation | ng | Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours) |
|
|
|
| Secondary | Fe: Fraction of Drug Excreted in Urine for TAK-063 | Fe is a measure of the fraction of drug excreted in urine and is calculated as Fe = (total amount excreted in the urine from time 0 to 24 hours post-dose / dose)×100 | PK Set included all randomized participants who received study drug for whom PK data was available for analysis. | Posted | Mean | Standard Deviation | percent | Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours) |
|
|
|
| Secondary | CLr: Renal Clearance of TAK-063 and TAK-063 Metabolite M-I | CLr is a measure of apparent clearance of the drug from the urine calculated as total amount excreted in the urine from time 0 to 24 hours postdose / plasma area under the curve from time 0 to 24 hours post-dose. | PK Set included all randomized participants who received study drug for whom PK data was available for analysis. | Posted | Mean | Standard Deviation | mL/hour | Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours) |
|
|
|
| 0 |
| 7 |
| 4 |
| 7 |
| EG001 | TAK-063 10 mg (Schizophrenia Participants) | TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia. | 0 | 8 | 7 | 8 |
| EG002 | TAK-063 20 mg (Schizophrenia Participants) | TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia. | 0 | 7 | 5 | 7 |
| EG003 | TAK-063 30 mg (Schizophrenia Participants) | TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia. | 0 | 8 | 6 | 8 |
| EG004 | TAK-063 100 mg (Schizophrenia Participants) | TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia. | 0 | 8 | 8 | 8 |
| EG005 | Placebo (Schizophrenia Participants) | Placebo matching TAK-063, tablets, orally, once daily for 7 days in participants with Schizophrenia. | 0 | 9 | 5 | 9 |
| EG006 | TAK-063 3 mg (Healthy Participants) | TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants. | 0 | 8 | 4 | 8 |
| EG007 | TAK-063 10 mg (Healthy Participants) | TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants. | 0 | 8 | 5 | 8 |
| EG008 | TAK-063 20 mg (Healthy Participants) | TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants. | 0 | 8 | 5 | 8 |
| EG009 | Placebo (Healthy Participants) | Placebo matching TAK-063, tablets, orally, once daily for 7 days in healthy Japanese participants. | 0 | 6 | 3 | 6 |
| Vision Blurred | Eye disorders | MedDRA version 17.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA version 17.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA version 17.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA version 17.0 | Systematic Assessment |
|
| Catheter Site Pain | General disorders | MedDRA version 17.0 | Systematic Assessment |
|
| Feeling Of Body Temperature Change | General disorders | MedDRA version 17.0 | Systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA version 17.0 | Systematic Assessment |
|
| Hordeolum | Infections and infestations | MedDRA version 17.0 | Systematic Assessment |
|
| Orthostatic Heart Rate Response Increased | Investigations | MedDRA version 17.0 | Systematic Assessment |
|
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA version 17.0 | Systematic Assessment |
|
| Musculoskeletal Stiffness | Musculoskeletal and connective tissue disorders | MedDRA version 17.0 | Systematic Assessment |
|
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA version 17.0 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA version 17.0 | Systematic Assessment |
|
| Akathisia | Nervous system disorders | MedDRA version 17.0 | Systematic Assessment |
|
| Extrapyramidal Disorder | Nervous system disorders | MedDRA version 17.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA version 17.0 | Systematic Assessment |
|
| Oromandibular Dystonia | Nervous system disorders | MedDRA version 17.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA version 17.0 | Systematic Assessment |
|
| Dizziness Postural | Nervous system disorders | MedDRA version 17.0 | Systematic Assessment |
|
| Dyskinesia | Nervous system disorders | MedDRA version 17.0 | Systematic Assessment |
|
| Dystonia | Nervous system disorders | MedDRA version 17.0 | Systematic Assessment |
|
| Disturbance In Attention | Nervous system disorders | MedDRA version 17.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA version 17.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA version 17.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA version 17.0 | Systematic Assessment |
|
| Psychotic Disorder | Psychiatric disorders | MedDRA version 17.0 | Systematic Assessment |
|
| Menopausal Symptoms | Reproductive system and breast disorders | MedDRA version 17.0 | Systematic Assessment |
|
| Throat Irritation | Respiratory, thoracic and mediastinal disorders | MedDRA version 17.0 | Systematic Assessment |
|
| Dermal Cyst | Skin and subcutaneous tissue disorders | MedDRA version 17.0 | Systematic Assessment |
|
| Exfoliative Rash | Skin and subcutaneous tissue disorders | MedDRA version 17.0 | Systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA version 17.0 | Systematic Assessment |
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| Orthostatic Hypotension | Vascular disorders | MedDRA version 17.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA version 17.0 | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA version 17.0 | Systematic Assessment |
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| Vessel Puncture Site Pain | General disorders | MedDRA version 17.0 | Systematic Assessment |
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| Oral Herpes | Infections and infestations | MedDRA version 17.0 | Systematic Assessment |
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| Nail Injury | Injury, poisoning and procedural complications | MedDRA version 17.0 | Systematic Assessment |
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| Traumatic Haematoma | Injury, poisoning and procedural complications | MedDRA version 17.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA version 17.0 | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA version 17.0 | Systematic Assessment |
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| Restlessness | Psychiatric disorders | MedDRA version 17.0 | Systematic Assessment |
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Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.
| TAK-063 M-I Day 1 |
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| TAK-063 Day 7 (n=7, 7, 7, 7, 7, 8, 7, 6) |
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| TAK-063 M-I Day 7 (n=7, 7, 7, 7, 7, 8, 7, 6) |
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| TAK-063 M-I Day 1 |
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| TAK-063 Day 7 (n=7, 7, 7, 7, 7, 8, 7, 6) |
|
| TAK-063 M-I Day 7 (n=7, 7, 7, 7, 7, 8, 7, 6) |
|
| TAK-063 M-I Day 1 |
|
| TAK-063 Day 7 (n=7, 7, 7, 7, 7, 8, 7, 6) |
|
| TAK-063 M-I Day 7 (n=7, 7, 7, 7, 7, 8, 7, 6) |
|
| TAK-063 M-I Day 1 |
|
| TAK-063 Day 7 (n=7, 7, 7, 7, 7, 8, 7, 6) |
|
| TAK-063 M-I Day 7 (n=7, 7, 7, 7, 7, 8, 7, 6) |
|
| TAK-063 Day 7 (n=7, 7, 7, 7, 7, 8, 7, 6) |
|
| TAK-063 M-I Day 1 |
|
| TAK-063 Day 7 (n=7, 7, 7, 7, 7, 8, 7, 6) |
|
| TAK-063 M-I Day 7 (n=7, 7, 7, 7, 7, 8, 7, 6) |
|
| TAK-063 M-I Day 7 (n=7, 7, 7, 7, 7, 8, 7, 6) |
|
| TAK-063 M-I Day 7 (n=7, 7, 7, 7, 7, 8, 7, 6) |
|
| TAK-063 M-I |
|
| TAK-063 M-I Day 1 |
|
| TAK-063 Day 7 (n=7, 7, 7, 7, 7, 8, 7, 6) |
|
| TAK-063 M-I Day 7 (n=7, 7, 7, 7, 7, 8, 7, 6) |
|
| Day 7 (n=7, 7, 7, 7, 7, 8, 7, 6) |
|
| TAK-063 M-I Day 1 (n=0, 8, 6, 7, 7, 0, 7, 8) |
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| TAK-063 Day 7 (n=0, 7, 6, 7, 7, 0, 6, 6) |
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| TAK-063 M-I Day 7 (n=2, 7, 6, 7, 7, 3, 6, 6) |
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