Safety, Tolerability, and Pharmacokinetics of Multiple Rising Doses of TAK-137 in Adults With Attention-Deficit/Hyperactivity Disorder.
Condition: Attention-Deficit/Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: TAK-137; TAK-137 Placebo
Intervention description: TAK-137 tablets; TAK-137 placebo-matching tablets
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 47.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Drug therapy

Summary:

      The purpose of this study is to characterize the safety and tolerability of TAK-137 when
      administered as multiple oral doses in adults with attention-deficit/hyperactivity disorder
      (ADHD).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Is a male or female adult who is 18 to 55 years of age, inclusive.

          2. Weighs at least 45 kg and has a body mass index (BMI) between 18 and 30.0 kg/m^2,
             inclusive at Screening.

          3. Has a documented diagnosis of attention-deficit/hyperactivity disorder (ADHD) for a
             minimum of 1 year.

          4. Is willing to discontinue all medications to treat adult ADHD (eg, stimulants,
             antidepressants) and all other medications and dietary products as specified in the
             protocol, from Day -7 until Follow-up phone call (Day 14).

        Exclusion Criteria:

          1. Has received any investigational compound within 30 days prior to the first dose of
             study medication.

          2. Has uncontrolled, clinically significant neurologic (including mildly abnormal or
             significantly abnormal EEG at screening), cardiovascular, pulmonary, hepatic, renal,
             metabolic, gastrointestinal, urologic, immunologic, endocrine disease, or psychiatric
             disorder (other than ADHD), or other abnormality, which may impact the ability of the
             participant to participate or potentially confound the study results.

          3. Has previously had a seizure or convulsion (lifetime), including absence seizure and
             febrile convulsion.

          4. Has a positive urine drug result for drugs of abuse other than amphetamines or other
             medications to treat ADHD or positive result for alcohol at Screening or Check-in (Day
             -1).

          5. Has taken any excluded medication, supplements, or food products listed in the
             Excluded Medications and Dietary Products.

          6. Is pregnant or lactating or intending to become pregnant before, during, or within 12
             weeks after participating in this study; or intending to donate ova during such time
             period.

          7. 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).