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

Primary Purpose

Parkinson Disease

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

ITI-214

Placebo

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Atlanta Center for Medical Research
Duke Early Phase Research Unit

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Placebo Comparator

Arm Label

1 mg ITI-214

3 mg ITI-214

10 mg ITI-214

30 mg ITI-214

90 mg ITI-214

Placebo

Arm Description

Administered once daily for 7 days

Outcomes

Primary Outcome Measures

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

Safety and tolerability

Secondary Outcome Measures

Maximum Plasma Concentration (Cmax)

Pharmacokinetics

Area of the Curve (AUC)

Pharmacokinetics

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

Pharmacodynamics

Full Information

NCT ID

NCT03257046

First Posted

August 14, 2017

Last Updated

December 18, 2018

Sponsor

Intra-Cellular Therapies, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03257046

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2018

Overall Recruitment Status

Completed

Study Start Date

September 28, 2017 (Actual)

Primary Completion Date

September 6, 2018 (Actual)

Study Completion Date

September 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Intra-Cellular Therapies, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1 mg ITI-214

Arm Type

Experimental

Arm Description

Administered once daily for 7 days

Arm Title

3 mg ITI-214

Arm Type

Experimental

Arm Description

Administered once daily for 7 days

Arm Title

10 mg ITI-214

Arm Type

Experimental

Arm Description

Administered once daily for 7 days

Arm Title

30 mg ITI-214

Arm Type

Experimental

Arm Description

Administered once daily for 7 days

Arm Title

90 mg ITI-214

Arm Type

Experimental

Arm Description

Administered once daily for 7 days

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Administered once daily for 7 days

Intervention Type

Drug

Intervention Name(s)

ITI-214

Intervention Description

Oral

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Oral

Primary Outcome Measure Information:

Title

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

Description

Safety and tolerability

Time Frame

7 days

Secondary Outcome Measure Information:

Title

Maximum Plasma Concentration (Cmax)

Description

Pharmacokinetics

Time Frame

7 days

Title

Area of the Curve (AUC)

Description

Pharmacokinetics

Time Frame

7 days

Title

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

Description

Pharmacodynamics

Time Frame

7 days

Other Pre-specified Outcome Measures:

Title

Exploratory biomarkers

Description

Pharmacodynamics

Time Frame

7 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kimberly Vanover, PhD

Organizational Affiliation

Intra-Cellular Therapies, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Atlanta Center for Medical Research

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30331

Country

United States

Facility Name

Duke Early Phase Research Unit

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27708

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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