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

Schizophrenia Clinical Trial

Official title: A Phase 1, Randomized, Placebo- Controlled, Double-Blind Safety, Tolerability, Pharmacokinetic, and Exploratory Pharmacodynamic Study in Healthy Subjects and Subjects With Stable Schizophrenia After Multiple Doses of ITI-214

Status Terminated

Clinical Trial 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.

Clinical Trial Description

The drug being tested in this study is called ITI-214. This study will look at how well different doses of ITI-214 are tolerated in healthy people and in people with stable schizophrenia. In addition, exploratory neuroimaging will be conducted in participants with schizophrenia.

This multi-center trial will be conducted in the United States. The study will be comprised of 2 parts: Multiple-Rising Dose (MRD) and Neuroimaging (NI). Approximately 40 healthy participants are planned to be enrolled in the MRD part of the study and approximately 36 patients with stable schizophrenia are planned to be enrolled in the Neuroimaging part of the study.

Participants in the MRD (parallel design) part will be enrolled in cohorts for different dose levels. In each dose cohort, participants will be randomly assigned to active dose or placebo—which will remain undisclosed to participants and study doctor during the study (unless there is an urgent medical need). The following dose cohorts will be enrolled: Doses A, B, C, and D.

Participants will be asked to take the study drug in oral solution once daily for a total of 14 days while confined at the study site. Participants will be contacted by telephone 22 and 44 days after last dose of study drug for a follow-up assessment.

Participants in the Neuroimaging (NI) part of the study will be randomly assigned to one of six treatment sequences. Each sequence consists of 3 cross-over treatment periods. The following doses will be tested: Doses E, F, G, and H.

Each participant will undergo 3 treatment periods of placebo or ITI-214 once daily dosing for 7 days in each of the periods. There will be a washout period of a minimum of 7 days between treatment periods. Participants will be confined at the study site for 5 days of each treatment period and will report to the site on other dosing days for study drug administration. There will be follow-up assessments on Days 14 and 37 of Period 3.

Study was terminated due to business decision. The study compound is being transferred to Intra-Cellular Therapies, Inc. ;

Study Design

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

Related Conditions & MeSH terms

• Schizophrenia

• NCT number: NCT01900522
• Study type: Interventional
• Source: Takeda
• Status: Terminated
• Phase: Phase 1
• Start date: July 2013
• Completion date: December 2014