A Single-Dose Positron Emission Tomography (PET) Study to Determine the Effect of TAK-041 on Amphetamine-Induced Dopamine Release in the Central Nervous System (CNS)
Condition: Healthy Volunteers
Intervention: Amphetamine; TAK -041; [11C] (+)-4-propyl-(+)-4-propyl-9-hydroxynaphthoxazine (PHNO)
Intervention description: Amphetamine tablets.; TAK-041 oral suspension.; [11C]PHNO injection.
Intervention MeSH terms: Amphetamine; Naxagolide
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: Male
Minimum age: 20 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Drug therapy

Summary:

      The purpose of this study is to determine brain penetration of single oral doses of TAK-041
      and its effects on amphetamine-induced dopamine release in the Central Nervous System (CNS).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Is in good health as determined by physical examination, electrocardiogram (ECG), and
             laboratory evaluations.

          2. Weighs at least 45 kilogram (kg) and has a body mass index (BMI) from 18.0 to 30.0
             kilogram per square meter (kg/m^2), inclusive, at Screening.

        Exclusion Criteria:

          1. Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol
             abuse (defined as regular consumption of more than 21 units per week) within 1 year
             prior to the Screening Visit or is unwilling to agree to abstain from alcohol and
             drugs throughout the study. One unit is equivalent to 8 grams of pure alcohol, which
             is equivalent to 10 milliliter (mL) of pure ethanol (alcohol) or approximately a
             half-pint of beer, 1 measure of spirits, or 1 glass of wine.

          2. 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 on Day -1. Cotinine test is positive at Screening or Check-in (Day -1).

          3. Has poor peripheral venous access.

          4. Has donated or lost 450 mL or more of his blood volume (including plasmapheresis), or
             had a transfusion of any blood product within 90 days prior to Confinement Period 1.

          5. Has had previous research-related exposure to ionizing radiation such that, in
             combination with the exposure from this study, their exposure will be greater than
             (>)10 millisievert (mSv) for the previous year.

          6. Has a contraindication to magnetic resonance imaging (MRI) based on the standard MRI
             screening questionnaire. Contraindications include ferromagnetic foreign bodies
             (example, shrapnel, ferromagnetic fragments in the orbital area), certain implanted
             medical devices (example, aneurysm clips, cardiac pacemakers), or claustrophobia.

          7. Has findings on the screening brain MRI scan that will potentially compromise
             participant safety or the scientific integrity of the study data if the participant
             were to participate in this study.