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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 10 mg ITI-214 | Experimental | Single oral dose |
|
| 30 mg ITI-214 | Experimental | Single oral dose |
|
| 75 mg - 150 mg ITI-214 | Experimental | Single oral dose |
|
| Placebo | Placebo Comparator | Single oral dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ITI-214 | Drug | Oral |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Echocardiogram with Doppler imaging and hemodynamic monitoring | Cardiac systolic and diastolic function | 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 12-lead electrocardiogram (ECG) | Safety and tolerability | 2 hours |
| Hemodynamic monitoring | Cardiac systolic and diastolic function | 5-6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma and urine levels of cAMP and cGMP as Exploratory biomarkers | Pharmacodynamics | 2 hours |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University | Baltimore | Maryland | 21287 | United States | ||
| Duke Clinical Research Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34461742 | Derived | Gilotra NA, DeVore AD, Povsic TJ, Hays AG, Hahn VS, Agunbiade TA, DeLong A, Satlin A, Chen R, Davis R, Kass DA. Acute Hemodynamic Effects and Tolerability of Phosphodiesterase-1 Inhibition With ITI-214 in Human Systolic Heart Failure. Circ Heart Fail. 2021 Sep;14(9):e008236. doi: 10.1161/CIRCHEARTFAILURE.120.008236. Epub 2021 Aug 31. |
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| ID | Term |
|---|---|
| D054143 | Heart Failure, Systolic |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C000625407 | ITI-214 |
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| Placebo |
| Other |
Oral |
|
| Number of patients with treatment-emergent adverse events | Safety and tolerability | 5 days |
| Durham |
| North Carolina |
| 27710 |
| United States |