Safety, Tolerability, Pharmacokinetics and Pharmacodynami... | NCT03257046

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

NCT03257046

Sponsor

Intra-Cellular Therapies, Inc.

Status

Completed

Last Update Posted

Dec 20, 2018Actual

Enrollment

40Actual

Phase

Phase 1Phase 2

Conditions

Parkinson Disease

Interventions

ITI-214
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Sep 28, 2017Actual

Primary Completion Date

Sep 6, 2018Actual

Completion Date

Sep 28, 2018Actual

First Submitted Date

Aug 14, 2017

First Submission Date that Met QC Criteria

Aug 17, 2017

First Posted Date

Aug 22, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 18, 2018

Last Update Posted Date

Dec 20, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1 mg ITI-214	Experimental	Administered once daily for 7 days	Drug: ITI-214
3 mg ITI-214	Experimental	Administered once daily for 7 days	Drug: ITI-214
10 mg ITI-214	Experimental	Administered once daily for 7 days	Drug: ITI-214
30 mg ITI-214	Experimental	Administered once daily for 7 days	Drug: ITI-214
90 mg ITI-214	Experimental	Administered once daily for 7 days	Drug: ITI-214
Placebo	Placebo Comparator	Administered once daily for 7 days	Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ITI-214	Drug	Oral	1 mg ITI-214 10 mg ITI-214 3 mg ITI-214 30 mg ITI-214 90 mg ITI-214

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Maximum Plasma Concentration (Cmax)	Pharmacokinetics	7 days
Area of the Curve (AUC)	Pharmacokinetics	7 days

Other Outcomes

Measure	Description	Time Frame
Exploratory biomarkers	Pharmacodynamics	7 days

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kimberly Vanover, PhD	Intra-Cellular Therapies, Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Atlanta Center for Medical Research		Atlanta	Georgia	30331	United States
Duke Early Phase Research Unit

Condition Browse Module

MeSH Terms

ID	Term
D010300	Parkinson Disease

Ancestor Terms

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000625407	ITI-214

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided