Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ITI-214 in Parkinson's Disease
- Registration Number
- NCT03257046
- Lead Sponsor
- Intra-Cellular Therapies, Inc.
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Administered once daily for 7 days 30 mg ITI-214 ITI-214 Administered once daily for 7 days 10 mg ITI-214 ITI-214 Administered once daily for 7 days 1 mg ITI-214 ITI-214 Administered once daily for 7 days 3 mg ITI-214 ITI-214 Administered once daily for 7 days 90 mg ITI-214 ITI-214 Administered once daily for 7 days
- Primary Outcome Measures
Name Time Method Number of patients with reported or observed treatment-related adverse events 7 days Safety and tolerability
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (2)
Atlanta Center for Medical Research
🇺🇸Atlanta, Georgia, United States
Duke Early Phase Research Unit
🇺🇸Durham, North Carolina, United States