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Safety and Tolerability of Multiple Doses of ITI-214 in Healthy Adults and in Adults With Stable Schizophrenia

NCT01900522 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2015-02-19

No results posted yet for this study

Summary

The purpose of this study is to characterize the safety and tolerability profile of ITI-214 when administered as multiple doses of oral solution at escalating dose levels.

Conditions

Interventions

DRUG

ITI-214 Dose A

ITI-214 Dose A Oral Solution

DRUG

ITI-214 Dose B

ITI-214 Oral Solution Dose B

DRUG

ITI-214 Dose C

ITI-214 Dose C Oral Solution

DRUG

ITI-214 Dose D (Elderly)

ITI-214 Dose D (Elderly) Oral Solution

DRUG

Placebo

ITI-214 Matching Placebo Oral Solution

DRUG

ITI-214 Dose E

ITI-214 Dose E Oral Solution

DRUG

ITI-214 Dose F

ITI-214 Dose F Oral Solution

DRUG

ITI-214 Dose G

ITI-214 Dose G Oral Solution

DRUG

ITI-214 Dose H

ITI-214 Dose H Oral Solution

DRUG

Placebo

ITI-214 Matching Placebo Oral Solution

Sponsors & Collaborators

  • Intra-Cellular Therapies, Inc.

    collaborator INDUSTRY

  • Takeda

    lead INDUSTRY

Principal Investigators

  • Medical Director · Takeda

Study Design

Allocation
RANDOMIZED
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2014-09-30
Completion
2014-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
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 NCT01900522 on ClinicalTrials.gov