Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ITI-214 in Parkinson's Disease

December 18, 2018 updated by: Intra-Cellular Therapies, Inc.

A Randomized, Placebo-Controlled, Double-Blind Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of ITI-214 in Patients With Idiopathic Parkinson's Disease

This is a Phase I/II randomized, double-blind, placebo-controlled, multiple rising dose study in patients with stable idiopathic Parkinson's disease (PD) to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ITI-214.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

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

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30331
        • Atlanta Center for Medical Research
    • North Carolina
      • Durham, North Carolina, United States, 27708
        • Duke Early Phase Research Unit

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

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Major Inclusion Criteria:

  • Clinical diagnosis of idiopathic Parkinson's disease (PD)
  • Severity of PD assessed by Hoehn and Yahr Staging score of 1 to 3
  • Maintenance on stable PD therapy

Major Exclusion Criteria:

  • Clinical signs of dementia
  • Suicidal ideation or behavior
  • Considered medically inappropriate for study participation

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1 mg ITI-214
Administered once daily for 7 days
Drug: ITI-214
Oral
Experimental: 3 mg ITI-214
Administered once daily for 7 days
Drug: ITI-214
Oral
Experimental: 10 mg ITI-214
Administered once daily for 7 days
Drug: ITI-214
Oral
Experimental: 30 mg ITI-214
Administered once daily for 7 days
Drug: ITI-214
Oral
Experimental: 90 mg ITI-214
Administered once daily for 7 days
Drug: ITI-214
Oral
Placebo Comparator: Placebo
Administered once daily for 7 days
Other: Placebo
Oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with reported or observed treatment-related adverse events
Time Frame: 7 days
Safety and tolerability
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Plasma Concentration (Cmax)
Time Frame: 7 days
Pharmacokinetics
7 days
Area of the Curve (AUC)
Time Frame: 7 days
Pharmacokinetics
7 days
Motor and non-motor symptoms as assessed by the MDS-UPDRS
Time Frame: 7 days
Pharmacodynamics
7 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exploratory biomarkers
Time Frame: 7 days
Pharmacodynamics
7 days

Collaborators and Investigators

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

Sponsor

Intra-Cellular Therapies, Inc.

Investigators

  • Study Director: Kimberly Vanover, PhD, 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 (Actual)

September 28, 2017

Primary Completion (Actual)

September 6, 2018

Study Completion (Actual)

September 28, 2018

Study Registration Dates

First Submitted

August 14, 2017

First Submitted That Met QC Criteria

August 17, 2017

First Posted (Actual)

August 22, 2017

Study Record Updates

Last Update Posted (Actual)

December 20, 2018

Last Update Submitted That Met QC Criteria

December 18, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ITI-214-105

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.

Clinical Trials on Parkinson Disease

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Portugal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe