Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Ascending Single- and Multiple-Doses of TAK-020 in Healthy Volunteers

The drug being tested in this study is called TAK-020. TAK-020 is being tested to evaluate
safety and tolerability of single doses and 7 days multiple doses of TAK-020 in healthy
volunteers. This study will look at the PK characteristics (how the drug acts throughout the
body) of the drug and safety and tolerability (lab results, vital signs, ECG, and side
effects) in healthy participants who take TAK-020.

The study will enroll a total of approximately 120 participants. This study is designed to
consist of 2 sequential parts: Part 1-a SRD, and Part 2-a MRD. Healthy participants for Part
1 will be enrolled into 9 cohorts. Each cohort will have 8 randomized participants with
receiving a single dose of TAK-020, and 2 receiving matching placebo under fasted conditions.
In Cohorts 1-9 doses of 0.1, 0.5, 2.5, 4.4, 8.8, 17.5, 35, 70 and 105 mg will be evaluated.

Healthy participants for Part 2 will be enrolled into 7 cohorts. Each cohort will have 8
randomized participants, with participants receiving one dose of TAK-020 on Day 1, followed
by a washout on Day 2, then daily dosing on Days 3-9 of TAK-020 with 2 participants receiving
matching placebo under fasted conditions. In Cohorts 1-4 doses of 3.75, 5.75, 13 and 25 mg
will be evaluated. For Cohorts 5-7, the subsequent dose level is to be determined based on
data from Part 1 and review of safety, tolerability and PK data from Part 2 Cohorts 1-4.

This single-center trial will be conducted in the United States. The overall time to
participate in this study is up to 45 days. Participants in Part 1 will make multiple visits
to the clinic including a period of confinement to the clinic and will be contacted by
telephone 14 days after the last dose of study drug for a follow-up assessment. Participants
in Part 2 will make multiple visits to the clinic including a period of confinement to the
clinic and will be observed at the clinic 17 days after the last dose of study drug for a
follow-up assessment.

Inclusion Criteria

Participant eligibility is determined according to the following criteria prior to entry
into the study:

1. In the opinion of the investigator, the participant is capable of understanding and
complying with protocol requirements.

2. Participant 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 of any study procedures including requesting
that a participant fast for any laboratory evaluations.

3. Participant is a healthy adult male or female.

4. The participant is a health adult male or female aged 18 to 55 years, inclusive, at
the time of informed consent and first study medication dose.

5. The participant weighs at least 45 kilogram (kg) and has a body mass index (BMI)
between 18.0 and 32.0 kilogram per square meter (kg/m^2), inclusive at Screening and
Day -1.

6. A male participant who is nonsterilized and sexually active with a female partner of
childbearing potential agrees to use adequate contraception from signing of informed
consent throughout the duration of the study and for 12 weeks after last dose.

7. A female participant of childbearing potential who is sexually active with a
nonsterilized male partner agrees to use adequate contraception from signing of
informed consent throughout the duration of the study and until the next menstrual
period or 30 days after last dose, whichever is first. If the next menstrual period is
delayed, a pregnancy test will be required for exclusion of pregnancy.

Exclusion Criteria

Any participant who meets any of the following criteria will not qualify for entry into the
study:

1. The participant has received any investigational compound within 30 days prior to
Screening.

2. The participant is an immediate family member, study site employee, or in a dependent
relationship with a study site employee who is involved in the conduct of this study
(example, spouse, parent, child, sibling) or may consent under duress.

3. Participant has a known hypersensitivity to any component of the formulation of
TAK-020, Captisol or related compounds.

4. The participant has a positive urine drug result for drugs of abuse at Screening or
Check-in (Day -1).

5. The participant has a history of drug abuse (defined as any illicit drug use) or a
history of alcohol abuse (defined as 4 or more alcoholic beverages per day) within 1
year prior to the Screening visit or is unwilling to agree to abstain from alcohol and
drugs throughout the study. One unit is equivalent to a half-pint of beer or 1 measure
of spirits or 1 glass of wine.

6. Participant has taken any excluded medication, supplements, or food products,
Prohibited Medications and Dietary Products.

7. If female, the participant is pregnant or lactating or intending to become pregnant
before, during or within 1 month after exit from this study (30 days post last dose);
or intending to donate ova during such time period.

8. If male, the participant intends to donate sperm during the course of this study or
for 12 weeks thereafter.

9. Participant 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-020, 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.

10. Participant has current or recent (within 6 months) gastrointestinal disease that
would be expected to influence the absorption of drugs (that is, a history of
malabsorption, esophageal reflux, peptic ulcer disease, erosive esophagitis frequent
[more than once per week] occurrence of heartburn, or any surgical intervention
[example, cholecystectomy]).

11. Participant has a history of cancer, except basal cell carcinoma which has been in
remission for at least 5 years prior to Day 1.

12. Participant 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).

13. The participant has poor peripheral venous access.

14. Participant has donated or lost 450 milliliter (mL) or more of his or her blood volume
(including plasmapheresis), or had a transfusion of any blood product within 30 days
prior to Day 1.

15. Vaccination with any live vaccine within 4 weeks of study drug administration.

16. Participant has a Screening or Check-in (Day -1) abnormal (clinically significant)
ECG. Entry of any participant with an abnormal (not clinically significant) ECG must
be approved, and documented by signature by the principal investigator medically
qualified sub investigator.

17. Participant has QT interval with Fridericia correction method (QTcF) greater than (>)
450 millisecond (msec) for men and women or PR outside the range of 120 to 220 msec
confirmed upon repeat testing within a maximum of 30 minutes, at the Screening Visit
or Check-in (Day -1).

18. Participant has abnormal Screening or Day -1 laboratory values that suggest a
clinically significant underlying disease or participant with the following lab
abnormalities:

1. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >1.2* the
upper limit of normal (ULN).

2. Positive screen test for drugs of abuse.

3. Positive blood screen for hepatitis B surface antigen (HBsAg), hepatitis C virus
(HCV), or human immunodeficiency virus-1 or -2 antibodies.

4. A positive test for tuberculosis (TB) (QuantiFERON).