A Study to Assess the Relative Bioavailability and to Assess the Effect of Food on the Bioavailability of a TAK-648 Tablet in Healthy Participants
Condition: Healthy Volunteers
Intervention: TAK-648 Tablet; TAK-648 Oral Solution
Intervention description: Tak-648 tablet; TAK-648 oral solution
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
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 assess the relative bioavailability of a TAK-648 tablet
      compared with a TAK-648 oral solution, and to assess the effect of food on the
      bioavailability of a TAK-648 tablet in healthy participants.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Healthy male or female aged 18 to 55 years, inclusive, at the time of informed consent
             and first study medication dose.

          2. Weighs at least 50 kilogram (kg) (110 pounds [lbs]) and has a body mass index (BMI)
             from 18.0 to 30.0 kilogram per square meter (kg/m^2), inclusive at Screening.

          3. Has systolic blood pressure greater than (>) 90 and less than or equal to (<=) 150
             millimeter of mercury (mmHg) and diastolic blood pressure >60 and <=90 mm Hg at
             Screening and at Check-in (Day -1) of Period 1. If out of range, may be repeated once
             for eligibility determination within a maximum of 5 minutes.

          4. Has a calculated creatinine clearance >60 milliliter per minute (mL/min) at Screening
             and Check-in (Day -1) of Period 1.

          5. 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.

          6. Female participant of childbearing potential who is sexually active with a
             nonsterilized male partner agrees to use routinely adequate contraception from signing
             of informed consent and throughout the duration of the study and for 12 weeks after
             the last dose.

        Exclusion Criteria:

          1. Has received any investigational compound within 30 days prior to the first dose of
             study medication.

          2. Has received TAK-648 in a previous clinical study or as a therapeutic agent.

          3. Is an immediate family member, 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. Has any significant medical histories or currently uncontrolled clinical conditions,
             which may render it unsafe for participant to participate in the study, may impact the
             ability of the participant to participate in the study, or may potentially confound
             the study results.

          5. Has a history of significant gastrointestinal (GI) disorders manifested with
             persistent, chronic, or intermittent nausea, vomiting, or diarrhea, or has a current
             or recent (within 6 months) GI disease that would influence the absorption of drugs.

          6. Has diagnosis of major depression, bipolar disorder, or anxiety disorders, or has
             received any medication to treat any psychological disorders within 1 year.

          7. Has a risk of suicide according to the investigator's clinical judgment per
             Columbia-Suicide Severity Rating Scale (C-SSRS) at screening or has made a suicide
             attempt in the past 6 months prior to screening.

          8. Has known hypersensitivity to any component of the formulation of TAK-648, or to a
             phosphodiesterase type 4 (PDE4) inhibitor (example, roflumilast).

          9. Has taken any excluded medication, supplements, or food products during the time
             periods listed in the Prohibited Medications table.

         10. Has abnormal Screening or Check-in (Day -1) of Period 1 laboratory values that suggest
             a clinically significant underlying disease or participant has the following
             laboratory abnormalities: Alanine aminotransferase (ALT) and/or aspartate
             aminotransferase (AST) >2.5* upper limit of normal (ULN).