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

NCT01879722 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2026-05-08

Study results available
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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.

Conditions

Interventions

DRUG

TAK-063

TAK-063 tablets

DRUG

TAK-063 Placebo

TAK-063 placebo-matching tablets

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Takeda Global Research & Development Center, Inc. (Note: This product was divested to Axsome in 2026)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01879722 on ClinicalTrials.gov