Study of ITI-007 in Healthy Geriatric Volunteers and in Geriatric Patients With Dementia

November 13, 2017 updated by: Intra-Cellular Therapies, Inc.

A Randomized, Double-blind, Placebo-controlled, Multiple Oral Dose Escalation for Safety, Tolerability and Pharmacokinetics of ITI-007 in Healthy Geriatric Volunteers and in Geriatric Patients With Dementia.

A Phase 1b/2, Randomized, Double-blind, Placebo-Controlled, Multiple Oral Dose Escalation Study to Assess Safety, Tolerability and Pharmacokinetics of ITI-007 in Healthy Geriatric Volunteers and in Geriatric Patients with Dementia

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Part 1

  • Healthy geriatric volunteers
  • MMSE score of >= 26 at screening
  • BMI between 19.0 and 40.0 kg/m2 and a minimum body weight of 50 kg at screening

Part 2

  • Geriatric patients with a clinical diagnosis of dementia
  • MMSE score of < 26 at screening
  • BMI between 19.0 and 40.0 kg/m2 and a minimum body weight of 50 kg at screening

Exclusion Criteria:

  • Any clinically significant illness within 6 months before screening
  • Any history of cancer within last 5 years
  • History of Hepatitis B or C infection and elevated ALT, AST or bilirubin above the upper limit of normal level
  • Any subject considered to be an imminent danger to themselves or others

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ITI-007 Part 1
Part 1: Healthy geriatric volunteers with multiple oral dose escalation up to and including 20 mg ITI-007
Drug: ITI-007
ITI-007 for Part 1
Drug: ITI-007
ITI-007 for Part 2
Placebo Comparator: Placebo Part 1
Part 1: Healthy geriatric volunteers with placebo given
Drug: Placebo
ITI-007 for Part 1
Drug: Placebo
Placebo for Part 2
Experimental: ITI-007 Part 2
Part 2: Geriatric patients with dementia with ITI-007 given
Drug: ITI-007
ITI-007 for Part 1
Drug: ITI-007
ITI-007 for Part 2
Placebo Comparator: Placebo Part 2
Part 2: Geriatric patients with dementia with placebo given
Drug: Placebo
ITI-007 for Part 1
Drug: Placebo
Placebo for Part 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with adverse events
Time Frame: up to 7 days
Vital signs, 12-lead ECGs, clinical laboratory testing, and adverse events will be assessed.
up to 7 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Area under the concentration-time curve (AUC)
Time Frame: pre-dose and multiple collection points up to 72 h after the last dose
pre-dose and multiple collection points up to 72 h after the last dose

Other Outcome Measures

Outcome Measure
Time Frame
Exploratory measures of cognitive function
Time Frame: Baseline and up to 7 days
Baseline and up to 7 days
Exploratory measures of agitation
Time Frame: Baseline and up to 7 days
Baseline and up to 7 days
Exploratory measures of subjective sleep
Time Frame: Baseline and up to 7 days
Baseline and up to 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Intra-Cellular Therapies, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

February 28, 2014

First Submitted That Met QC Criteria

March 4, 2014

First Posted (Estimate)

March 5, 2014

Study Record Updates

Last Update Posted (Actual)

November 17, 2017

Last Update Submitted That Met QC Criteria

November 13, 2017

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ITI-007-200

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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