Safety, Tolerability and Pharmacokinetic Study of Multiple Rising Doses of TAK- 063 in Participants With Stable Schizophrenia and Healthy Participants

A Phase 1 study testing TAK-063 in people with Schizophrenia, run by Takeda at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Schizophrenia
What is being tested?: TAK-063
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 77 participants
Where: 1 siteUnited States
Study dates: Jun 2013to Jun 2014
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy Participants:
Aged 20-55 years, inclusive, at the time of informed consent and first study medication dose.
Is a healthy adult male or female of Japanese descent (born to Japanese parents and grandparents and has lived outside of Japan for less than 5 years).
Weighs at least 45 kg and has a body mass index (BMI) between 18.0 and 28.0 kg/m^2, inclusive, at Screening.
Participants with Stable Schizophrenia:
Is aged 18 to 55 years, inclusive, at the time of informed consent and first study medication dose.

Show all 10Show fewer

Is an adult male or female with a diagnosis of schizophrenia or schizoaffective disorder.
Weighs at least 45 kg and has a BMI between 18.0 and 35.0 kg/m^2, inclusive at Screening.
Has been receiving a stable dose of antipsychotic monotherapy for at least 1 month prior to Screening.
Has not had an acute exacerbation of psychosis or been hospitalization for the treatment of schizophrenia or schizoaffective disorder for at least 3 months prior to Screening.

Who cannot join

All Participants:
Has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, or endocrine disease or other abnormality (other than the disease being studied), which may impact the ability of the participant to participate or potentially confound the study results.
If female, the participant is pregnant or lactating or intending to become pregnant, or intending to donate ova, before, during the course of the study or within 12 weeks after last dose.
Intends to donate sperm during the course of this study or for 12 weeks after last dose.
Has evidence of current cardiovascular, central nervous system, hepatic, hematopoietic disease, renal dysfunction, metabolic or endocrine dysfunction, serious allergy, asthma hypoxemia, hypertension, seizures, or allergic skin rash. There is any finding in the participant's medical history, physical examination, or safety laboratory tests giving reasonable suspicion of a disease that would contraindicate taking TAK-063, or a similar drug in the same class, or that might interfere with the conduct of the study. This includes, but is not limited to, peptic ulcer disease, seizure disorders, and cardiac arrhythmias.
Healthy Participants:

Show all 12Show fewer

Has a history or treatment of Axis I/II mental disorders according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) such as depression, anxiety disorders, bipolar disorder, attention deficit hyperactivity disorder (ADHD), autism spectrum disorders, anorexia nervosa, bulimia nervosa or schizophrenia within the past 3 years.
Has used nicotine-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patch or nicotine gum) within 28 days prior to Check-in Day -1. Cotinine test is positive at Screening or Check-in (Day -1).
Participants with Stable Schizophrenia:
Has a history of a primary DSM-IV axis I diagnosis other than schizophrenia or schizoaffective disorder.
Has not discontinued antipsychotic or other psychotropic medications or is unable to discontinue antipsychotic or other psychotropic medications at Day -7 (or five half-lives prior to Day -1).
Is taking a concomitant medication for a medical condition at a stable dose or regimen for less than two months or is taking a concomitant medication for a medical condition for less than two months and for which the discontinuation for the study period is not medically permissible.

Trial locations and contacts

1 site in 1 country.

United States1 site

Study site
Glendale, California

Other trials in United States

About this study

Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability and Pharmacokinetic Study of Multiple Rising Doses of TAK- 063 in Subjects With Stable Schizophrenia and Healthy Japanese Subjects

Read the detailed description

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.

Conditions: Schizophrenia
Being tested: TAK-063, TAK-063 Placebo
Keywords: Drug therapy
Medical subject headings: Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TAK-063Drug
TAK-063 tablets
TAK-063 PlaceboDrug
TAK-063 placebo-matching tablets

Study groups in NCT01879722
Study group	Role	What they receive
TAK-063 3 mg	Experimental	TAK-063 3 mg, tablets, orally, once daily for 7 days. Receives: Drug: TAK-063
TAK-063 10 mg	Experimental	TAK-063 10 mg, tablets, orally, once daily for 7 days. Receives: Drug: TAK-063
TAK-063 20 mg	Experimental	TAK-063 20 mg, tablets, orally, once daily for 7 days. Receives: Drug: TAK-063
TAK-063 30 mg	Experimental	TAK-063 30 mg, tablets, orally, once daily for 7 days. Receives: Drug: TAK-063
TAK-063 100 mg	Experimental	TAK-063 100 mg, tablets, orally, once daily for 7 days. Receives: Drug: TAK-063
Placebo	Placebo comparator	Placebo matching TAK-063, tablets, orally, once daily for 7 days. Receives: Drug: TAK-063 Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: Day 1 to Day 8

Secondary outcomes (12)

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.
Measured: Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2013Jun 2014

First posted18 Jun 2013 (estimated)
Study startJun 2013
Primary completionJun 2014
Study completionJun 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for SchizophreniaStudies of the same condition, open and under way.
More trials run by TakedaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 77 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01879722
Sponsor's protocol ID: TAK-063_104
Other IDs: U1111-1139-5355
Status last verified: Apr 2026
First submitted: 13 Jun 2013
Last updated: 8 May 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 29103081

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Schizophrenia trials

Study at a glance

From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability and Pharmacokinetic Study of Multiple Rising Doses of TAK- 063 in Subjects With Stable Schizophrenia and Healthy Japanese Subjects
ClinicalTrials.gov ID: NCT01879722
Acronym / sponsor ID: TAK-063_104
Conditions: Schizophrenia
Keywords: Drug therapy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 77 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: Jun 2013
Primary completion: Jun 2014 (actual)
Study completion: Jun 2014 (actual)
First posted: 18 Jun 2013 (estimated)
Results: Posted 28 Oct 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
TAK-063 3 mg	Experimental	Drug: TAK-063TAK-063 3 mg, tablets, orally, once daily for 7 days.
TAK-063 10 mg	Experimental	Drug: TAK-063TAK-063 10 mg, tablets, orally, once daily for 7 days.
TAK-063 20 mg	Experimental	Drug: TAK-063TAK-063 20 mg, tablets, orally, once daily for 7 days.
TAK-063 30 mg	Experimental	Drug: TAK-063TAK-063 30 mg, tablets, orally, once daily for 7 days.
TAK-063 100 mg	Experimental	Drug: TAK-063TAK-063 100 mg, tablets, orally, once daily for 7 days.
Placebo	Placebo comparator	Drug: TAK-063 PlaceboPlacebo matching TAK-063, tablets, orally, once daily for 7 days.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (10 listed)

Aged 20-55 years, inclusive, at the time of informed consent and first study medication dose.
Is a healthy adult male or female of Japanese descent (born to Japanese parents and grandparents and has lived outside of Japan for less than 5 years).
Weighs at least 45 kg and has a body mass index (BMI) between 18.0 and 28.0 kg/m^2, inclusive, at Screening.
Is aged 18 to 55 years, inclusive, at the time of informed consent and first study medication dose.
Is an adult male or female with a diagnosis of schizophrenia or schizoaffective disorder.

Key exclusion criteria (12 listed)

Has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, or endocrine disease or other abnormality (other than the disease being studied), which may impact the ability of the participant to participate or potentially confound the study results.
If female, the participant is pregnant or lactating or intending to become pregnant, or intending to donate ova, before, during the course of the study or within 12 weeks after last dose.
Intends to donate sperm during the course of this study or for 12 weeks after last dose.
Has evidence of current cardiovascular, central nervous system, hepatic, hematopoietic disease, renal dysfunction, metabolic or endocrine dysfunction, serious allergy, asthma hypoxemia, hypertension, seizures, or allergic skin rash. There is any finding in the participant's medical history, physical examination, or safety laboratory tests giving reasonable suspicion of a disease that would contraindicate taking TAK-063, or a similar drug in the same class, or that might interfere with the conduct of the study. This includes, but is not limited to, peptic ulcer disease, seizure disorders, and cardiac arrhythmias.
Has a history or treatment of Axis I/II mental disorders according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) such as depression, anxiety disorders, bipolar disorder, attention deficit hyperactivity disorder (ADHD), autism spectrum disorders, anorexia nervosa, bulimia nervosa or schizophrenia within the past 3 years.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TAK-063TAK-063 tablets	Drug	TAK-063 10 mg, TAK-063 100 mg, TAK-063 20 mg, TAK-063 3 mg, TAK-063 30 mg
TAK-063 PlaceboTAK-063 placebo-matching tablets	Drug	Placebo

Primary outcome

Percentage of Participants Who Experience at Least One Treatment-Emergent Adverse Event (TEAE) After 7 Days of Dosing
Time frame: Day 1 to Day 14
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.
Percentage of Participants With Markedly Abnormal Safety Laboratory Tests
Time frame: Day 1 to Day 8
The percentage of participants with any markedly abnormal standard safety laboratory values, including hematology, serum chemistries, and urinalysis, during the treatment period.
Percentage of Participants With Markedly Abnormal Vital Sign Measurements
Time frame: Day 1 to Day 8
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
Percentage of Participants With Markedly Abnormal Values of 12-Lead Electrocardiogram (ECG) Parameters
Time frame: Day 1 to Day 8
The percentage of participants who meet markedly abnormal criteria specified by the protocol and statistical analysis plan during the treatment period.

12 secondary outcomes

Cmax: Maximum Observed Plasma Concentration for TAK-063 and TAK-063 Metabolite M-I
Time frame: Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours)
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-063 and TAK-063 Metabolite M-I
Time frame: 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
Time frame: 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
Time frame: Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours)
CL/F: Oral Clearance of TAK-063
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours)

Results and safety

Results posted to the registry on 28 Oct 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TAK-063 3 mg (Schizophrenia Participants)	7	7
TAK-063 10 mg (Schizophrenia Participants)	8	7
TAK-063 20 mg (Schizophrenia Participants)	7	7
TAK-063 30 mg (Schizophrenia Participants)	8	7
TAK-063 100 mg (Schizophrenia Participants)	8	7
Placebo (Schizophrenia Participants)	9	9
TAK-063 3 mg (Healthy Participants)	8	8
TAK-063 10 mg (Healthy Participants)	8	7
TAK-063 20 mg (Healthy Participants)	8	6
Placebo (Healthy Participants)	6	6

Primary outcome: Percentage of Participants Who Experience at Least One Treatment-Emergent Adverse Event (TEAE) After 7 Days of Dosing

Time frame: Day 1 to Day 14. Number. Unit: percentage of participants

Measure	TAK-063 3 mg (Schizophrenia Participants) n = 7	TAK-063 10 mg (Schizophrenia Participants) n = 8	TAK-063 20 mg (Schizophrenia Participants) n = 7	TAK-063 30 mg (Schizophrenia Participants) n = 8	TAK-063 100 mg (Schizophrenia Participants) n = 8	Placebo (Schizophrenia Participants) n = 9	TAK-063 3 mg (Healthy Participants) n = 8	TAK-063 10 mg (Healthy Participants) n = 8	TAK-063 20 mg (Healthy Participants) n = 8	Placebo (Healthy Participants) n = 6
Value	57.1	87.5	71.4	75.0	100.0	55.6	50.0	62.5	62.5	50.0

Population analysed: Safety population included all randomized participants who received at least one dose of study drug.

Primary outcome: Percentage of Participants With Markedly Abnormal Safety Laboratory Tests

Time frame: Day 1 to Day 8. Number. Unit: percentage of participants

Measure	TAK-063 3 mg (Schizophrenia Participants) n = 7	TAK-063 10 mg (Schizophrenia Participants) n = 8	TAK-063 20 mg (Schizophrenia Participants) n = 7	TAK-063 30 mg (Schizophrenia Participants) n = 8	TAK-063 100 mg (Schizophrenia Participants) n = 8	Placebo (Schizophrenia Participants) n = 9	TAK-063 3 mg (Healthy Participants) n = 8	TAK-063 10 mg (Healthy Participants) n = 8	TAK-063 20 mg (Healthy Participants) n = 8	Placebo (Healthy Participants) n = 6
Value	0	0	0	0	0	0	25.0	0	0	0

Population analysed: Safety population included all randomized participants who received at least one dose of study drug.

Primary outcome: Percentage of Participants With Markedly Abnormal Vital Sign Measurements

Time frame: Day 1 to Day 8. Number. Unit: percentage of participants

Measure	TAK-063 3 mg (Schizophrenia Participants) n = 7	TAK-063 10 mg (Schizophrenia Participants) n = 8	TAK-063 20 mg (Schizophrenia Participants) n = 7	TAK-063 30 mg (Schizophrenia Participants) n = 8	TAK-063 100 mg (Schizophrenia Participants) n = 8	Placebo (Schizophrenia Participants) n = 9	TAK-063 3 mg (Healthy Participants) n = 8	TAK-063 10 mg (Healthy Participants) n = 8	TAK-063 20 mg (Healthy Participants) n = 8	Placebo (Healthy Participants) n = 6
Value	71.4	100.0	100.0	100.0	100.0	100.0	100.0	100.0	100.0	100.0

Population analysed: Safety population included all randomized participants who received at least one dose of study drug.

Primary outcome: Percentage of Participants With Markedly Abnormal Values of 12-Lead Electrocardiogram (ECG) Parameters

Time frame: Day 1 to Day 8. Number. Unit: percentage of participants

Measure	TAK-063 3 mg (Schizophrenia Participants) n = 7	TAK-063 10 mg (Schizophrenia Participants) n = 8	TAK-063 20 mg (Schizophrenia Participants) n = 7	TAK-063 30 mg (Schizophrenia Participants) n = 8	TAK-063 100 mg (Schizophrenia Participants) n = 8	Placebo (Schizophrenia Participants) n = 9	TAK-063 3 mg (Healthy Participants) n = 8	TAK-063 10 mg (Healthy Participants) n = 8	TAK-063 20 mg (Healthy Participants) n = 8	Placebo (Healthy Participants) n = 6
Value	57.1	50.0	57.1	75.0	62.5	44.4	50.0	75.0	50.0	33.3

Population analysed: Safety population included all randomized participants who received at least one dose of study drug.

12 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TAK-063 3 mg (Schizophrenia Participants)	0 of 7 (0%)	4 of 7 (57.1%)	Not reported
TAK-063 10 mg (Schizophrenia Participants)	0 of 8 (0%)	7 of 8 (87.5%)	Not reported
TAK-063 20 mg (Schizophrenia Participants)	0 of 7 (0%)	5 of 7 (71.4%)	Not reported
TAK-063 30 mg (Schizophrenia Participants)	0 of 8 (0%)	6 of 8 (75%)	Not reported
TAK-063 100 mg (Schizophrenia Participants)	0 of 8 (0%)	8 of 8 (100%)	Not reported
Placebo (Schizophrenia Participants)	0 of 9 (0%)	5 of 9 (55.6%)	Not reported
TAK-063 3 mg (Healthy Participants)	0 of 8 (0%)	4 of 8 (50%)	Not reported
TAK-063 10 mg (Healthy Participants)	0 of 8 (0%)	5 of 8 (62.5%)	Not reported
TAK-063 20 mg (Healthy Participants)	0 of 8 (0%)	5 of 8 (62.5%)	Not reported
Placebo (Healthy Participants)	0 of 6 (0%)	3 of 6 (50%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29103081Goldsmith 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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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Takeda Global Research & Development Center, Inc. (Note: This product was divested to Axsome in 2026)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TAK-063 in people with Schizophrenia, run by Takeda at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Who Experience at Least One Treatment-Emergent Adverse Event (TEAE) After 7 Days of Dosing (time frame: Day 1 to Day 14). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01879722, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026; AzTrials last refreshed its copy on 7 Nov 2026.