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

Three 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) 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.

Inclusion Criteria:

Healthy Participants:

1. Aged 20-55 years, inclusive, at the time of informed consent and first study
medication dose.

2. 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).

3. 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:

1. Is aged 18 to 55 years, inclusive, at the time of informed consent and first study
medication dose.

2. Is an adult male or female with a diagnosis of schizophrenia or schizoaffective
disorder.

3. Weighs at least 45 kg and has a BMI between 18.0 and 35.0 kg/m^2, inclusive at
Screening.

4. Has been receiving a stable dose of antipsychotic monotherapy for at least 1 month
prior to Screening.

5. 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.

Exclusion Criteria:

All Participants:

1. 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.

2. 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.

3. Intends to donate sperm during the course of this study or for 12 weeks after last
dose.

4. 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:

1. 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.

2. 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:

1. Has a history of a primary DSM-IV axis I diagnosis other than schizophrenia or
schizoaffective disorder.

2. 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).

3. 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.