Receptor Occupancy of ITI-007 Using Positron Emission Tom... | NCT02288845

Studies
Receptor Occupancy of ITI-007 Using Positron Emission Tomography (PET) in Patients With Stable Schizophrenia

NCT02288845

Sponsor

Intra-Cellular Therapies, Inc.

Status

Completed

Last Update Posted

Mar 10, 2017Actual

Enrollment

14Actual

Phase

Phase 2

Conditions

Schizophrenia

Interventions

ITI-007

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2014

Primary Completion Date

Jul 2015Actual

Completion Date

Sep 2015Actual

First Submitted Date

Oct 31, 2014

First Submission Date that Met QC Criteria

Nov 7, 2014

First Posted Date

Nov 11, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Mar 9, 2017

Certification/Extension First Submitted that Passed QC Review

Mar 9, 2017

Certification/Extension First Posted Date

Mar 10, 2017Actual

Last Update Submitted Date

Mar 9, 2017

Last Update Posted Date

Mar 10, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to determine the relationship between ITI-007 dose, plasma levels and brain receptor occupancy in patients with stable schizophrenia.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

14Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ITI-007	Experimental	ITI-007 formulated capsule will be administered orally once daily for up to 14 days in up to 14 subjects.	Drug: ITI-007

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ITI-007	Drug		ITI-007

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Brain Receptor Occupancy as Measured by Positron Emission Tomography		Up to 14 days

Secondary Outcomes

Measure	Description	Time Frame
Safety and Tolerability as Measured by Number of Participants with Adverse Events		Up to 14 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with schizophrenia who are drug-free with regard to their antipsychotic medication
In clinical remission and free from acute exacerbation of their psychosis
In good health

Exclusion Criteria:

Clinically significant medical conditions considered inappropriate for trial participation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kimberly Vanover, Ph.D.	Intra-Cellular Therapies, Inc. (ITI)	Study Director
Dean F. Wong, M.D., Ph.D.	Johns Hopkins University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Johns Hopkins Medical Institutions		Baltimore	Maryland	21287	United States

Condition Browse Module

MeSH Terms

ID	Term
D012559	Schizophrenia

Ancestor Terms

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000705749	lumateperone

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided