A Study to Evaluate the Mass Balance, Pharmacokinetics (PK), Metabolism and Excretion of TAK-954 Containing Microtracer ([14C]-TAK-954) in Healthy Male Participants
Condition: Healthy Volunteers
Intervention: [14C]-TAK-954
Intervention description: [14C]-TAK-954 intravenous infusion.
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: Male
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Drug therapy

Summary:

      The purpose of this study is to determine the mass balance, routes of elimination and
      characterize the metabolic profiles of a single intravenous dose of [14C]-TAK-954, identify
      major circulating and excreted metabolites. This study will also determine the single-dose PK
      of total radioactivity, TAK-954 and its metabolites where possible.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Be a man aged 18 to 55 years, inclusive, at the screening visit.

          2. Have a body mass index (BMI) greater than or equal to (>=) 18 and less than or equal
             to (<=) 30 kilogram per square meter (kg/m^2) and a body weight greater than (>) 50
             kilogram (kg) at the screening visit.

          3. Be a nonsmoker who has not used tobacco- or nicotine-containing products (example,
             nicotine patch) for at least 6 months before administration of the initial dose of
             trial drug.

          4. Meet the following birth control requirements:

               -  Is a male participant who is sterile or agrees to use an appropriate method of
                  contraception, including a condom, from the first dose of study drug until 30
                  days after the last dose of study drug. No restrictions are required for a
                  vasectomized male participant provided that the participant is at least 1 year
                  postbilateral vasectomy procedure before the first dose of study drug. A male
                  participant whose vasectomy procedure was performed less than 1 year before the
                  first dose of study drug must follow the same restrictions as a nonvasectomized
                  man. Appropriate documentation of surgical procedures should be provided.

               -  Is a male participant who agrees to not donate sperm from trial drug
                  administration on the first day of the first dose until 30 days after the last
                  dose of study drug.

        Exclusion Criteria:

          1. Has total 14C radioactivity measured by accelerator mass spectrometry in plasma
             (during screening) exceeding 14C/12C ratio 1.1E-12.

          2. Participated in any study with a radiation dose above 0.1 millibecquerel (MBq) or
             radiation burden above 0.1 millisievert (mSv) within 1 year before screening.

          3. Was exposed to significant radiation (example, serial x-ray or computed tomography
             scans, barium meal, current employment in a job requiring radiation exposure
             monitoring) within 12 months before check-in.

          4. Irregular defecation pattern (less than once per 2 days).

          5. Has a history of alcohol consumption exceeding 2 standard drinks per day on average (1
             glass is approximately equivalent to beer 354 milliliter [mL]/12 ounce [oz], wine 118
             mL/4 oz, or distilled spirits 29.5 mL/1 oz).

          6. Consumes excessive amounts, defined as greater than 6 servings (1 serving is
             approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, energy drinks,
             or other caffeinated beverages per day.

          7. Has a substance abuse disorder.