Randomized, Double-Blind, Placebo-Controlled, Safety and Tolerability Study of ITI-214 in Patients With Heart Failure
Sponsor
Intra-Cellular Therapies, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT03387215
Collaborator
(none)
36
2
4
20.2
18
0.9
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
36 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Randomized, Double-Blind, Placebo-Controlled, Safety and Tolerability Study of Escalating Single Doses of ITI-214 in Patients With Systolic Heart Failure
Actual Study Start Date
:
Jul 10, 2018
Actual Primary Completion Date
:
Mar 16, 2020
Actual Study Completion Date
:
Mar 16, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 10 mg ITI-214 Single oral dose |
Drug: ITI-214
Oral
|
| Experimental: 30 mg ITI-214 Single oral dose |
Drug: ITI-214
Oral
|
| Experimental: 75 mg - 150 mg ITI-214 Single oral dose |
Drug: ITI-214
Oral
|
| Placebo Comparator: Placebo Single oral dose |
Other: Placebo
Oral
|
Outcome Measures
Primary Outcome Measures
- Echocardiogram with Doppler imaging and hemodynamic monitoring [2 hours]
Cardiac systolic and diastolic function
Secondary Outcome Measures
- 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 Outcome Measures
- Plasma and urine levels of cAMP and cGMP as Exploratory biomarkers [2 hours]
Pharmacodynamics
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 80 Years
Sexes Eligible for Study:
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Johns Hopkins University | Baltimore | Maryland | United States | 21287 |
| 2 | Duke Clinical Research Institute | Durham | North Carolina | United States | 27710 |
Sponsors and Collaborators
- Intra-Cellular Therapies, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Intra-Cellular Therapies, Inc.
ClinicalTrials.gov Identifier:
NCT03387215
Other Study ID Numbers:
- ITI-214-104
First Posted:
Jan 2, 2018
Last Update Posted:
Dec 24, 2020
Last Verified:
Dec 1, 2020
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: