NCT03387215CompletedPhase 1
Randomized, Double-Blind, Placebo-Controlled, Safety and Tolerability Study of Escalating Single Doses of ITI-214 in Patients With Systolic Heart Failure
Intra-Cellular Therapies, Inc.2 sites in 1 country36 target enrollmentStarted: July 10, 2018Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 36
- Locations
- 2
- Primary Endpoint
- Echocardiogram with Doppler imaging and hemodynamic monitoring
Study Overview
Brief Summary
This is a Phase I/II randomized, double-blind, placebo-controlled, single rising dose study in patients with systolic heart failure to evaluate the safety and tolerability of ITI-214.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •NYHA class II-III heart failure
- •Ejection fraction equal to or below 35%
- •On stable heart failure drug treatment
Exclusion Criteria
- •Considered medically inappropriate for study participation
Arms & Interventions
10 mg ITI-214
Experimental
Single oral dose
Intervention: ITI-214 (Drug)
30 mg ITI-214
Experimental
Single oral dose
Intervention: ITI-214 (Drug)
75 mg - 150 mg ITI-214
Experimental
Single oral dose
Intervention: ITI-214 (Drug)
Placebo
Placebo Comparator
Single oral dose
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
Echocardiogram with Doppler imaging and hemodynamic monitoring
Time Frame: 2 hours
Cardiac systolic and diastolic function
Secondary Outcomes
- 12-lead electrocardiogram (ECG)(2 hours)
- Hemodynamic monitoring(5-6 hours)
- Number of patients with treatment-emergent adverse events(5 days)
Investigators
Study Sites (2)
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