Conditions: Attention-Deficit/Hyperactivity Disorder
Keywords: Drug therapy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 47
Healthy volunteers: no

Brief 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).

Detailed description:
The drug being tested in this study is called TAK-137. TAK-137 is being tested to find a safe and well-tolerated dose and to assess how TAK-137 is metabolized in people with attention-deficit/ hyperactivity disorder (ADHD). This study will look at side effects and lab results in people who take TAK-137. This study is designed as a randomized, sequential-cohort, multiple rising dose study.

Therefore, the TAK-137 2 mg Cohort will not start until the TAK-137 0.5 mg Cohort has completed, etc.

This trial will be conducted in the United States. The overall time to participate in this study is up to 42 days. Participants will make at least 2 visits to the clinic, including one 9-day period of confinement to the clinic. All participants will be contacted by telephone 7 days after the last dose of study drug for a follow-up assessment.

A decision was made to terminate this study so that emerging data from preclinical studies could be further assessed.

Arms:
arm 1: TAK-137 0.5 mg, tablets, orally once on Days 1-7. arm 2: TAK-137 2 mg, tablets, orally once on Days 1-7. arm 3: TAK-137 5 mg, tablets, orally once on Days 1-7. arm 4: TAK-137 10 mg, tablets, orally once on Days 1-7. arm 5: TAK-137, tablets, orally once on Days 1-7. Dose to be determined from data collected in Cohorts 1-3. arm 6: TAK-137 placebo-matching tablets, orally, once on Days 1-7.

Interventions: intervention 1: TAK-137 intervention 2: TAK-137 Placebo
Intervention descriptions: intervention 1: TAK-137 tablets intervention 2: TAK-137 placebo-matching tablets

Protocol document: