Heart Failure, Systolic
Conditions
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.
Interventions
DRUGITI-214
Oral
OTHERPlacebo
Oral
Sponsors
Intra-Cellular Therapies, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Echocardiogram with Doppler imaging and hemodynamic monitoring | 2 hours | Cardiac systolic and diastolic function |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 12-lead electrocardiogram (ECG) | 2 hours | Safety and tolerability |
| Hemodynamic monitoring | 5-6 hours | Cardiac systolic and diastolic function |
| Number of patients with treatment-emergent adverse events | 5 days | Safety and tolerability |
Other
| Measure | Time frame | Description |
|---|---|---|
| Plasma and urine levels of cAMP and cGMP as Exploratory biomarkers | 2 hours | Pharmacodynamics |
Countries
United States
Outcome results
None listed