Schizophrenia Clinical Trial
Official title:
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability and Pharmacokinetic Study of Multiple Rising Doses of TAK- 063 in Subjects With Stable Schizophrenia and Healthy Japanese Subjects
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.
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.
Three 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) 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.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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