Single-Dose Phase 1 Study of TAK-792
Condition: Healthy Male Adults Participants
Intervention: TAK-792 30 mg; TAK-792 30 mg placebo; TAK-792 100 mg; TAK-792 100 mg placebo; TAK-792 250 mg; TAK-792 250 mg placebo; TAK-792 500 mg; TAK-792 500 mg placebo; TAK-792 750 mg; TAK-792 750 mg placebo; TAK-792 1250 mg; TAK-792 1250 mg placebo
Intervention description: TAK-792 30 mg was administered in the morning after a fast.; TAK-792 30 mg placebo was administered in the morning after a fast.; TAK-792 100 mg was administered in the morning after a fast.; TAK-792 100 mg placebo was administered in the morning after a fast.; TAK-792 250 mg was administered in the morning after a fast.; TAK-792 250 mg placebo was administered in the morning after a fast.; TAK-792 500 mg was administered in the morning after a fast or after breakfast.; TAK-792 500 mg placebo was administered in the morning after a fast or after breakfast.; TAK-792 750 mg was administered in the morning after a fast.; TAK-792 750 mg placebo was administered in the morning after a fast.; TAK-792 1250 mg was administered in the morning after a fast.; TAK-792 1250 mg placebo was administered in the morning after a fast.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 72.0
Sex: Male
Minimum age: 20 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to characterize the safety and tolerability profile of TAK-792
      when administered as a single oral dose in healthy Japanese and Caucasian male participants.
    

Eligibility criteria:

        Inclusion Criteria:

          1. In the opinion of the investigator or sub-investigator, the participant is capable of
             understanding and complying with protocol requirements.

          2. The participant signs and dates a written, informed consent form and any required
             privacy authorization prior to the initiation of any study procedures.

          3. The participant is a healthy male of Japanese descent (born to Japanese parents and
             grandparents) or Caucasian descent (born to Caucasian parents and grandparents).

          4. The participant is aged 20 to 45 years, inclusive, at the time of informed consent.

          5. The participant weighs at least 50 kilogram (kg) and has a body mass index (BMI)
             between 18.5 kilogram per square meter (kg/m^2) and 25.0 kg/m^2 for Japanese, BMI
             between 18.5 kg/m^2 and 30.0 kg/m^2 for Caucasian, 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.

        Exclusion Criteria:.

          1. The participant has received any investigational compound within 16 weeks (112 days)
             prior to the dose of study medication.

          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
             (eg, spouse, parent, child, sibling) or may consent under duress.

          3. The participant has uncontrolled, clinically significant neurologic, cardiovascular,
             pulmonary, hepatic, renal, metabolic, gastrointestinal, urological, or endocrine
             disease or other abnormality, which may impact the ability of the participant to
             participate or potentially confound the study results.

          4. The participant has a positive urine drug result for drugs of abuse at Screening.

          5. The participant has a history of drug abuse (defined as any illicit drug use) or a
             history of alcohol abuse within 2 years prior to the Screening visit or is unwilling
             to agree to abstain from alcohol and drugs throughout the study.

          6. Participant has taken any excluded medication, supplements, or food products listed in
             the Excluded Medications and Dietary Products table.

          7. The participant intends to donate sperm during the course of this study or for 12
             weeks thereafter.

          8. 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.

          9. Participant has current or recent (within 6 months) gastrointestinal disease that
             would be expected to influence the absorption of drugs (ie, a history of
             malabsorption, esophageal reflux, peptic ulcer disease, erosive esophagitis frequent
             [more than once per week] occurrence of heartburn, or any surgical intervention [eg,
             cholecystectomy]).

         10. Participant has a history of cancer, except basal cell carcinoma which has been in
             remission for at least 5 years prior to Day 1.

         11. Participant has a positive test result for hepatitis B surface antigen (HBsAg),
             hepatitis C antibody (HCV), human immunodeficiency virus (HIV) antibody/antigen, or
             serological reactions for syphilis at Screening.

         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.

         13. The participant has poor peripheral venous access.

         14. The participant has undergone whole blood collection of at least 200 milliliter (mL)
             within 4 weeks (28 days) or at least 400 mL within 12 weeks (84 days) prior to the
             start of study drug administration.

         15. The participant has undergone whole blood collection of at least 800 mL in total
             within 52 weeks (364 days) prior to the start of study drug administration.

         16. The participant has undergone blood component collection within 2 weeks (14 days)
             prior to the start of study drug administration.

         17. Participant has a Screening abnormal (clinically significant) electrocardiogram (ECG).

         18. Participant has abnormal Screening laboratory values that suggest a clinically
             significant underlying disease or participant with the following lab abnormalities:
             alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) greater than
             (>)1.5 the upper limits of normal.

         19. Participant who, in the opinion of the investigator or sub-investigator, is unlikely
             to comply with the protocol or is unsuitable for any other reason.