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
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease
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
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
Experimental
Experimental
Experimental
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
Administered once daily for 7 days
Administered once daily for 7 days
Administered once daily for 7 days
Administered once daily for 7 days
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
No
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
No
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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