Conditions: Healthy Volunteers
Keywords: Drug Therapy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 48
Healthy volunteers: yes

Brief summary:
The purpose of this study is to characterize the safety and tolerability profile of TAK-935 in healthy participants when administered as a single dose of oral solution at escalating dose levels.

Detailed description:
The drug being tested in this study is TAK-935. TAK-935 is being tested to find a safe and well-tolerated dose and to assess how TAK-935 is processed by the body. This study will look at side effects and lab results in people who take TAK-935 and is designed as a randomized dose-rising study.

The study will consist of 6 Cohorts with 8 participants in each Cohort. In each Cohort, 6 participants will receive a single dose of TAK-935 and 2 participants will receive placebo after a 10-hour fast. The starting dose will be 15 mg followed by planned doses of 50, 200, 600, 900 and not to exceed 1350 mg in subsequent cohorts.

This single-center trial will be conducted in the United States. The overall time to participate in this study is up to 51 days. Participants will make 2 visits to the clinic, including one 7-day period of confinement to the clinic. All participants will be contacted by telephone 14 days after the dose of study drug for a follow-up assessment.

Arms:
arm 1: TAK-935 15 mg solution, orally, once, on Day 1. arm 2: TAK-935 50 mg solution, orally, once, on Day 1. arm 3: TAK-935 200 mg solution, orally, once, on Day 1. arm 4: TAK-935 600 mg solution, orally, once, on Day 1. arm 5: TAK-935 900 mg solution, orally, once, on Day 1. arm 6: TAK-935 1350 mg solution, orally, once, on Day 1. arm 7: TAK-935 placebo-matching solution, orally, once, on Day 1.

Interventions: intervention 1: TAK-935 intervention 2: Placebo
Intervention descriptions: intervention 1: TAK-935 oral solution intervention 2: TAK-935 placebo-matching oral solution

Protocol document: