Back to resultsReceptor Occupancy of ITI-007 Using Positron Emission Tomography (PET) in Patients With Stable Schizophrenia
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ITI-007
Sponsored by
About this trial
This is an interventional basic science trial for Schizophrenia
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
Sites / Locations
- Johns Hopkins Medical Institutions
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ITI-007
Arm Description
ITI-007 formulated capsule will be administered orally once daily for up to 14 days in up to 14 subjects.
Outcomes
Primary Outcome Measures
Brain Receptor Occupancy as Measured by Positron Emission Tomography
Secondary Outcome Measures
Safety and Tolerability as Measured by Number of Participants with Adverse Events
Full Information
NCT ID
NCT02288845
First Posted
October 31, 2014
Last Updated
March 9, 2017
Sponsor
Intra-Cellular Therapies, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02288845
Brief Title
Receptor Occupancy of ITI-007 Using Positron Emission Tomography (PET) in Patients With Stable Schizophrenia
Official Title
An Open-Label Positron Emission Tomography (PET) Study to Demonstrate Receptor Occupancy, Safety, Tolerability and Pharmacokinetics of ITI-007 in Stable Schizophrenia Patients
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Intra-Cellular Therapies, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ITI-007
Arm Type
Experimental
Arm Description
ITI-007 formulated capsule will be administered orally once daily for up to 14 days in up to 14 subjects.
Intervention Type
Drug
Intervention Name(s)
ITI-007
Primary Outcome Measure Information:
Title
Brain Receptor Occupancy as Measured by Positron Emission Tomography
Time Frame
Up to 14 days
Secondary Outcome Measure Information:
Title
Safety and Tolerability as Measured by Number of Participants with Adverse Events
Time Frame
Up to 14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kimberly Vanover, Ph.D.
Organizational Affiliation
Intra-Cellular Therapies, Inc. (ITI)
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Dean F. Wong, M.D., Ph.D.
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Medical Institutions
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Receptor Occupancy of ITI-007 Using Positron Emission Tomography (PET) in Patients With Stable Schizophrenia
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