A Study of TAK-951 in Healthy Adults
Condition: Healthy Volunteers
Intervention: TAK-951 Placebo; TAK-951
Intervention description: TAK-951 placebo-matching SC injection; TAK-951 SC injection
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 128.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Drug Therapy

Summary:

      This is a study of TAK-951 for people with symptoms of nausea and vomiting. The main aims of
      this study in healthy adults are as follows:

        -  To check for side effects from TAK-951 when given at a slow and fast infusion rate.

        -  To learn how much TAK-951 participants can receive without getting side effects from it.

        -  To check how much TAK-951 stays in the blood over time to work out the best dose.

      Participants will receive a single infusion of either TAK-951 or placebo. In this study, a
      placebo looks like TAK-951 but does not have any medicine in it. Participants will receive
      either a low dose or high dose of TAK-951. The infusion will take from 1-3 hours.

      Participants will stay in the study clinic for about 4 days to receive the study medicine
      (TAK-951 or placebo) and check for side effects. They will have follow-up visits at the
      clinic about 2 weeks and 4 weeks after treatment.
    

Eligibility criteria:

        Inclusion Criteria:

        1. Have a body mass index (BMI) ≥18 and ≤30.0 (kg/m^2) at the Screening Visit.

        Exclusion Criteria:

          1. The participant has a positive test result for hepatitis B surface antigen, hepatitis
             C virus antibody, or human immunodeficiency antibody/antigen, at the Screening Visit.
             Note: Participants with positive hepatitis B virus or hepatitis C virus serology may
             be enrolled if quantitative polymerase chain reaction for hepatitis B virus or
             hepatitis C virus ribonucleic acid is negative.

          2. The participant had major surgery or donated or lost 1 unit of blood (approximately
             500 mL) within 4 weeks before the Screening Visit.

          3. Heavy consumption of alcohol within 3 months before screening (>7 drinks/week for
             women, >14 drinks/week for men, where 1 drink = 5 ounces [150 mL] of wine or 12 ounces
             [360 mL] of beer or 1.5 ounces [45 mL] of hard liquor) or use of soft drugs (such as
             marijuana) within 3 months before screening, or hard drugs (such as cocaine and
             phencyclidine) within 1 year before Screening.

          4. The participant has used nicotine-containing products (including, but not limited to,
             cigarettes, pipes, cigars, chewing tobacco, nicotine patch, or nicotine gum) within 28
             days before check-in (Day -1) or cotinine test is positive at Screening or Day -1.

          5. The participant has had 3 incidences of vasovagal syncope within the last 5 years.

          6. The participant has Brugada syndrome (right bundle branch block [RBBB] pattern with
             ST-elevation in leads V1-V3).

          7. The participant has an average semirecumbent systolic blood pressure <90 millimeters
             of mercury (mm Hg) or diastolic blood pressure <60 mm Hg at Screening or admission.

          8. The participant has an average heart rate (HR) <60 or >100 beats per minute (bpm) [at
             Screening, at Day -1, or at predose]; athletic participants with an average HR <60 bpm
             can be enrolled only with medical monitor approval.

          9. The participant has orthostatic hypotension defined as a decrease in systolic blood
             pressure ≥20 mm Hg or a decrease in diastolic blood pressure ≥10 mm Hg after 2 minutes
             of standing when compared with blood pressure from the sitting position at Screening,
             and at Day -1. Participants with postural orthostatic tachycardia, defined as HR >120
             bpm standing, will also be excluded.