A Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study of TAK-828 Escalating Multiple-Doses in Healthy Participants
Condition: Healthy Volunteers
Intervention: TAK-828; Placebo
Intervention description: TAK-828 solution.; TAK-828 placebo-matching solution.
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 24.0
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 and tolerability of multiple oral doses
      of TAK-828 in healthy participants.
    

Eligibility criteria:

        Inclusion:

        For Parts 1 and 2, 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. The 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. The participant is a healthy male, or a healthy female not of child-bearing potential.
             Females not of childbearing potential are defined as those who have been surgically
             sterilized (hysterectomy, bilateral oophorectomy or tubal ligation) or who are
             postmenopausal (example, defined as at least 1 year since last regular menses, with a
             follicle-stimulating hormone [FSH] level of greater than (>) 40 international units
             per liter [IU/L] or at least 5 years since last regular menses confirmed before any
             study drug is administered).

          4. For Part 1: the participant is a non-Japanese adult, aged 18 to 55 years (inclusive)
             at the time of informed consent and first dose of study drug.

          5. For Part 1: the participant weighs at least 50 kilogram (kg) and has a body mass index
             (BMI) of 18 to 30 kilogram per square meter (kg/m^2) (inclusive) at Screening.

          6. For Part 2: the participant is of Japanese descent (born to Japanese parents and
             grandparents), aged 20 to 55 years (inclusive) at the time of informed consent and
             first dose of study drug.

          7. For Part 2: the participant weighs at least 45 kg and has a BMI of 18.5 to 25 kg/m^2
             (inclusive) at Screening.

        Exclusion Criteria

        For Parts 1 and 2, any participant who meets any of the following criteria will not qualify
        for entry into the study:

          1. The participant received any investigational compound within 30 days or 5 half-lives
             (whichever is longer) before the first dose of study drug.

          2. The participant used prescription or nonprescription drugs and dietary supplements
             within 7 days or 5 half-lives (whichever is longer) before Check-in (Day -1). Herbal
             supplements and hormone replacement therapy (HRT) must be discontinued 28 days prior
             to Check-in (Day -1). As an exception, acetaminophen may be used at doses of less than
             or equal to (<=) 1 gram/day. Limited use of nonprescription medications that are not
             believed to affect participant safety or the overall results of the study may be
             permitted on a case-by-case basis following approval by the sponsor.

          3. The participant is an immediate family member or study-site employee or is 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.

          4. The participant has a history or presence of any disease or condition (or there is any
             finding upon review of the participant's medical history, physical examination, or
             clinical laboratory tests giving reasonable suspicion of a disease) that could
             interfere with study participation or safety, contraindicate taking TAK-828 or a
             similar drug in the same class, or potentially confound the study results (example,
             history or presence of clinically significant neurologic, cardiovascular, pulmonary,
             hepatic, hematologic, renal, immunologic, metabolic, musculoskeletal,
             gastrointestinal, endocrine, or psychiatric disease). It is the responsibility of the
             investigator to assess the clinical significance; however, consultation with the
             Takeda medical monitor may be warranted.

          5. The participant has a known hypersensitivity to any component of the formulation of
             TAK-828.

          6. The participant has an active infection at Screening.

          7. The participant has a positive urine drug result for drugs of abuse (defined as any
             illicit drug use) at Screening or Check-in (Day -1).

          8. The participant has a history of drug abuse (defined as any illicit drug use) or a
             history of alcohol abuse within 1 year, or the participant drinks 7 or more
             drinks/week for females or 14 or more drinks/week for males (1 drink=5 ounces [150
             milliliter {mL}] of wine, 12 ounces [360 mL] of beer, or 1.5 ounces [45 mL] of hard
             liquor) within 6 months before the Screening visit or is unwilling to abstain from
             alcohol and drugs throughout the study.

          9. The participant is taking or took any excluded medication, supplements, or food
             products during the time periods listed in the Prohibited Medications, Foods, and
             Products table

         10. If male, the participant intends to donate sperm during the course of this study or
             for 14 weeks after the last dose of study drug.

         11. The participant has any condition possibly affecting drug absorption (example,
             gastrectomy).

         12. The participant has a history of cancer, except basal cell carcinoma that has been in
             remission for at least 5 years before Screening.

         13. The participant has a positive test result for hepatitis B surface antigen (HBsAg) or
             hepatitis C virus (HCV) antibody at Screening or has a known history of human
             immunodeficiency virus (HIV) infection.

         14. The participant 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) or cotinine test is positive at Screening or Check-in
             (Day -1).

         15. The participant has poor peripheral venous access.

         16. The participant donated or lost 450 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.

         17. The 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 of the principal investigator or medically
             qualified subinvestigator.

         18. The participant has abnormal Screening or Day -1 laboratory values that suggest a
             clinically significant underlying disease or the participant has the following
             laboratory abnormalities: alanine aminotransferase (ALT) and/or aspartate
             aminotransferase (AST) > 3 times the upper limit of normal (ULN).

         19. The participant has a creatine kinase isoenzyme MB (CK-MB) or cardiac troponin above
             the ULN at Screening or Day -1.

         20. If female, the participant is of childbearing potential (example, premenopausal, not
             sterilized).