Safety, Tolerability and Pharmacokinetic Study of Multiple Rising Doses of TAK- 063 in Participants With Stable Schizophrenia and Healthy Participants

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

Status Completed

Clinical Trial 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.

Clinical Trial 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.

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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

• NCT number: NCT01879722
• Study type: Interventional
• Source: Takeda
• Status: Completed
• Phase: Phase 1
• Start date: July 2013
• Completion date: June 2014