Conditions: Schizophrenia
Keywords: Drug therapy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 77
Healthy volunteers: yes

Brief summary:
The purpose of this study is to characterize the safety and tolerability of TAK-063 when administered as multiple oral doses at escalating dose levels in participants with stable schizophrenia and in healthy Japanese participants.

Detailed description:
The drug being tested in this study is called TAK-063. TAK-063 is being tested to find a well-tolerated dose and also to treat schizophrenia. This study will look at how well different doses of TAK-063 are tolerated in healthy people of Japanese descent and in people with stable schizophrenia.

Five dose levels will be examined, starting at the lowest, in each population with 10 participants in each dose level. These participants will be randomized to receive TAK-063 (8 subjects) and placebo (2 subjects) once daily (QD) for 7 days.

In total, approximately 60 participants will be enrolled in the study. This trial will be conducted in single site in the United States. The overall time to participate in this study is up to 42 days. Participants will make 2 visits to the clinic, including 8-10 days confinement to the clinic, and will be contacted by telephone 7 days after last dose of study drug for a follow-up assessment.

Dose escalation and the actual choice of the subsequent dose level will only occur following a review of the blinded data from the previous cohorts.

Arms:
arm 1: TAK-063 3 mg, tablets, orally, once daily for 7 days. arm 2: TAK-063 10 mg, tablets, orally, once daily for 7 days. arm 3: TAK-063 20 mg, tablets, orally, once daily for 7 days. arm 4: TAK-063 30 mg, tablets, orally, once daily for 7 days. arm 5: TAK-063 100 mg, tablets, orally, once daily for 7 days. arm 6: Placebo matching TAK-063, tablets, orally, once daily for 7 days.

Interventions: intervention 1: TAK-063 intervention 2: TAK-063 Placebo
Intervention descriptions: intervention 1: TAK-063 tablets intervention 2: TAK-063 placebo-matching tablets

Protocol document: