Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Ascending Single- and Multiple-Doses of TAK-020 in Healthy Volunteers
Condition: Healthy Volunteers
Intervention: TAK-020; TAK-020 Placebo
Intervention description: TAK-020 oral solution; TAK-020 placebo-matching oral solution
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Drug therapy

Summary:

      The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of
      ascending single- and multiple-doses of TAK-020 in healthy participants.
    

Eligibility criteria:

        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).