Study to Assess Absolute Bioavailability of TAK-935 (OV935) and to Characterize Mass Balance, Pharmacokinetics, Metabolism, and Excretion of [14C]TAK-935 (OV935) in Healthy Male Participants
Condition: Healthy Volunteers
Intervention: TAK-935 Oral Tablet; [14C]TAK-935 IV Infusion; [14C]TAK-935 Oral Solution
Intervention description: TAK-935 tablet; [14C]TAK-935 IV infusion; [14C]TAK-935 oral solution
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: 19 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Drug Therapy

Summary:

      The purpose of this study is to determine absolute bioavailability (ABA) of TAK-935 (F)
      following a single microdose intravenous (IV) administration of 50 microgram (μg)
      (approximately 1 microcurie [μCi]) [14C]TAK-935 and a single oral administration of 3×100 mg
      milligram (mg) TAK-935 tablets in Treatment Period 1, and to assess the mass balance,
      characterize the pharmacokinetics (PK) of TAK-935 and metabolite [M-I (N-oxide)] in plasma
      and urine, and total radioactivity concentration equivalents in plasma and whole blood
      following a single oral administration of 300 mg (approximately 100 μCi) [14C]TAK-935 in
      Treatment Period 2.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Weighs at least 50 kg and body mass index (BMI) ≥18.0 and ˂32.0 kg/m^2 at Screening
             Visit.

          2. Continuous nonsmoker who has not used nicotine-containing products (including vaping)
             for at least 3 months prior to the first dosing and throughout the study, based on
             participant self-reporting.

          3. Medically healthy with no clinically significant medical history, physical
             examination, laboratory profiles, vital signs or ECGs, as deemed by the Investigator
             or designee.

        Exclusion Criteria:

          1. History or presence of cataracts or other clinically significant vision disturbances.

          2. Abnormal and clinically significant ECG abnormality at Screening visit:

               -  QT interval with Fridericia's correction method (QTcF) >450 milliseconds (ms)
                  confirmed with one repeat testing.

          3. History or presence of gastritis, gastrointestinal tract, gastric bypass surgery, or
             hepatic disorder or other clinical condition which, in the opinion of the Investigator
             or designee, may affect the absorption, distribution, metabolism, or elimination of
             study drug.

          4. Has a risk of suicide according to the Investigator's clinical judgment [e.g., per
             Columbia-Suicide Severity Rating Scale (C-SSRS)] or has made a suicide attempt in the
             previous year prior to Screening Visit.

          5. Positive urine drug or alcohol results at screening or first check-in.

          6. Positive results at screening for human immunodeficiency virus (HIV), hepatitis B
             surface antigen (HBsAg), hepatitis C virus (HCV) or novel coronavirus 2019 (COVID-19).

          7. Seated blood pressure is less than 90/40 millimeter of mercury (mmHg) or greater than
             140/90 mmHg at Screening.

          8. Seated HR is lower than 40 beats per minute (bpm) or higher than 99 bpm at Screening
             Visit.

          9. Estimated creatinine clearance <80 mL/min at Screening Visit.

         10. Has tattoo(s) or scarring at or near the site of IV infusion or any other condition
             which may interfere with infusion site examination, in the opinion of the
             Investigator.

         11. Has infrequent bowel movements (less than approximately once per day) within 30 days
             prior to first dosing.

         12. Recent history of abnormal bowel movements, such as diarrhea, loose stools, or
             constipation, within 2 weeks prior to first dosing.

         13. Has received radiolabeled substances or has been exposed to radiation sources within
             12 months of first dosing or is likely to receive radiation exposure or radioisotopes
             within 12 months of first dosing such that participation in this study would increase
             their total exposure beyond the recommended levels considered safe [i.e., weighted
             annual limit recommended by the International Commission on Radiological Protection
             (ICRP) of 3000 milli roentgen equivalent man (mrem)].

         14. Unable to refrain from or anticipates the use of:

               1. Any drug, including prescription and nonprescription medications, herbal
                  remedies, or vitamin supplements within 14 days prior to the first dosing and
                  throughout the study, including the Follow-up Period. Thyroid hormone replacement
                  medication may be permitted if the participant has been on the same stable dose
                  for the immediate 3 months prior to first study drug administration. After the
                  first dose of study drug, ibuprofen (up to 1.2 g per 24 hours) may be
                  administered at the discretion of the Investigator or designee. Milk of Magnesia
                  (i.e., magnesium hydroxide) (≤60 mL per day) may be administered to ensure
                  defecation, at discretion of the Investigator or designee.

               2. Any drugs known to be significant inducers of cytochrome P450 (CYP)3A4, CYP2C19
                  or uridine diphosphate glucuronosyltransferase (UGT), including St. John's Wort,
                  within 28 days prior to the first dosing and throughout the study, including the
                  Follow-up Period. Appropriate sources (e.g., Flockhart Table^TM) will be
                  consulted to confirm lack of PK/pharmacodynamic interaction with study drug(s).

               3. Alcohol

         15. Has been on a diet incompatible with the on-study diet, in the opinion of the
             Investigator or designee, within the 30 days prior to the first dosing and throughout
             the study.

         16. Donation of blood or significant blood loss within 56 days prior to the first dosing.

         17. Plasma donation within 7 days prior to the first dosing.