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

Sponsor

Intra-Cellular Therapies, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT03257046

Collaborator

(none)

Enrollment

Locations

Arms

Actual Duration (Months)

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease	Drug: ITI-214 Other: Placebo	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Multiple rising dose in sequential cohorts of 8 patients randomized in a 6:2 ratio to receive ITI-214 or placeboMultiple rising dose in sequential cohorts of 8 patients randomized in a 6:2 ratio to receive ITI-214 or placebo

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 28, 2017

Actual Primary Completion Date :

Sep 6, 2018

Actual Study Completion Date :

Sep 28, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Number of patients with reported or observed treatment-related adverse events [7 days]
Safety and tolerability

Secondary Outcome Measures

Maximum Plasma Concentration (Cmax) [7 days]
Pharmacokinetics
Area of the Curve (AUC) [7 days]
Pharmacokinetics
Motor and non-motor symptoms as assessed by the MDS-UPDRS [7 days]
Pharmacodynamics

Other Outcome Measures

Exploratory biomarkers [7 days]
Pharmacodynamics

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Atlanta Center for Medical Research	Atlanta	Georgia	United States	30331
2	Duke Early Phase Research Unit	Durham	North Carolina	United States	27708

Sponsors and Collaborators

Intra-Cellular Therapies, Inc.

Investigators

Study Director: Kimberly Vanover, PhD, Intra-Cellular Therapies, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Intra-Cellular Therapies, Inc.

ClinicalTrials.gov Identifier:

NCT03257046

Other Study ID Numbers:

ITI-214-105

First Posted:

Aug 22, 2017

Last Update Posted:

Dec 20, 2018

Last Verified:

Dec 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Parkinson Disease

Study Results

No Results Posted as of Dec 20, 2018