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Randomized, Double-Blind, Placebo-Controlled, Safety and Tolerability Study of ITI-214 in Patients With Heart Failure

Primary Purpose

Heart Failure, Systolic

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ITI-214
Placebo
Sponsored by
Intra-Cellular Therapies, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure, Systolic

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Johns Hopkins University
  • Duke Clinical Research Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

10 mg ITI-214

30 mg ITI-214

75 mg - 150 mg ITI-214

Placebo

Arm Description

Single oral dose

Single oral dose

Single oral dose

Single oral dose

Outcomes

Primary Outcome Measures

Echocardiogram with Doppler imaging and hemodynamic monitoring
Cardiac systolic and diastolic function

Secondary Outcome Measures

12-lead electrocardiogram (ECG)
Safety and tolerability
Hemodynamic monitoring
Cardiac systolic and diastolic function
Number of patients with treatment-emergent adverse events
Safety and tolerability

Full Information

First Posted
December 18, 2017
Last Updated
December 23, 2020
Sponsor
Intra-Cellular Therapies, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03387215
Brief Title
Randomized, Double-Blind, Placebo-Controlled, Safety and Tolerability Study of ITI-214 in Patients With Heart Failure
Official Title
Randomized, Double-Blind, Placebo-Controlled, Safety and Tolerability Study of Escalating Single Doses of ITI-214 in Patients With Systolic Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
July 10, 2018 (Actual)
Primary Completion Date
March 16, 2020 (Actual)
Study Completion Date
March 16, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Intra-Cellular Therapies, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Systolic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
10 mg ITI-214
Arm Type
Experimental
Arm Description
Single oral dose
Arm Title
30 mg ITI-214
Arm Type
Experimental
Arm Description
Single oral dose
Arm Title
75 mg - 150 mg ITI-214
Arm Type
Experimental
Arm Description
Single oral dose
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Single oral dose
Intervention Type
Drug
Intervention Name(s)
ITI-214
Intervention Description
Oral
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Oral
Primary Outcome Measure Information:
Title
Echocardiogram with Doppler imaging and hemodynamic monitoring
Description
Cardiac systolic and diastolic function
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
12-lead electrocardiogram (ECG)
Description
Safety and tolerability
Time Frame
2 hours
Title
Hemodynamic monitoring
Description
Cardiac systolic and diastolic function
Time Frame
5-6 hours
Title
Number of patients with treatment-emergent adverse events
Description
Safety and tolerability
Time Frame
5 days
Other Pre-specified Outcome Measures:
Title
Plasma and urine levels of cAMP and cGMP as Exploratory biomarkers
Description
Pharmacodynamics
Time Frame
2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Duke Clinical Research Institute
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34461742
Citation
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.
Results Reference
derived

Learn more about this trial

Randomized, Double-Blind, Placebo-Controlled, Safety and Tolerability Study of ITI-214 in Patients With Heart Failure

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