Conditions: Healthy Volunteers
Keywords: Drug therapy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 40
Healthy volunteers: yes

Brief summary:
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of multiple doses of TAK-058 in healthy non-elderly and elderly participants.

Detailed description:
The drug being tested in this study is TAK-058, which is under evaluation for the treatment of schizophrenia.

This study will enroll approximately 32 healthy non-elderly and 8 healthy elderly participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the five treatment groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):

* Cohort 1 Non-elderly Healthy: TAK-058 25 mg
* Cohort 2 Non-elderly Healthy: TAK-058 75 mg
* Cohort 3 Non-elderly Healthy: TAK-058 150 mg
* Cohort 4 Elderly Healthy: TAK-058 25 mg
* Cohort 5 Non-elderly Healthy: TAK-058 300 mg
* Cohort 1-4 Non Elderly Placebo (dummy inactive solution) - this is an oral solution that looks like the study drug but has no active ingredient.
* Cohort 5 Elderly Placebo This single-center trial will be conducted in the United States. The overall time to participate in this study is 40 days if assigned to Cohort 1 to 4. Participants will be confined to the clinic for 12 days, and will be contacted by telephone 11 and 30 days after last dose of study drug for a follow-up assessment (Days 21 and 40).

The overall time to participate in this study is 14 days if assigned to Cohort 5. Participants will be confined to the clinic for 4 days, and will be contacted by telephone 14 days after last dose of study drug for a follow-up assessment (Day 14).

Arms:
arm 1: TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants. arm 2: TAK-058 75 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants. arm 3: TAK-058 150 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants. arm 4: TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in elderly healthy participants. arm 5: TAK-058 300 mg solution, orally, once daily on Day 1, in non-elderly healthy participants. arm 6: TAK-058 placebo-matching solution, orally, once daily on Day 1 and Days 4 through 10 (Cohorts 1, 2 and 3), or TAK-058 placebo-matching solution, orally, once on Day 1 (Cohort 5), in non-elderly healthy participants. arm 7: TAK-058 placebo-matching solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.

Interventions: intervention 1: TAK-058 intervention 2: TAK-058 Placebo
Intervention descriptions: intervention 1: TAK-058 Solution intervention 2: TAK-058 placebo-matching solution

Protocol document: