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

Intra-Cellular Therapies, Inc.40 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Parkinson Disease

Interventions

ITI-214DRUG

Oral

PlaceboOTHER

Oral

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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

Locations (2)

Atlanta Center for Medical Research

Atlanta, Georgia, United States

Duke Early Phase Research Unit

Durham, North Carolina, United States

Outcomes

Primary Outcomes

Number of patients with reported or observed treatment-related adverse events

Safety and tolerability

Time frame: 7 days

Secondary Outcomes

Maximum Plasma Concentration (Cmax)

Pharmacokinetics

Time frame: 7 days

Area of the Curve (AUC)

Pharmacokinetics

Time frame: 7 days

Motor and non-motor symptoms as assessed by the MDS-UPDRS

Pharmacodynamics

Time frame: 7 days

Data from ClinicalTrials.gov

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