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

December 23, 2020 updated by: Intra-Cellular Therapies, Inc.

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins University
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke Clinical Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SEQUENTIAL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Echocardiogram with Doppler imaging and hemodynamic monitoring
Time Frame: 2 hours
Cardiac systolic and diastolic function
2 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
12-lead electrocardiogram (ECG)
Time Frame: 2 hours
Safety and tolerability
2 hours
Hemodynamic monitoring
Time Frame: 5-6 hours
Cardiac systolic and diastolic function
5-6 hours
Number of patients with treatment-emergent adverse events
Time Frame: 5 days
Safety and tolerability
5 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma and urine levels of cAMP and cGMP as Exploratory biomarkers
Time Frame: 2 hours
Pharmacodynamics
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Intra-Cellular Therapies, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 10, 2018

Primary Completion (ACTUAL)

March 16, 2020

Study Completion (ACTUAL)

March 16, 2020

Study Registration Dates

First Submitted

December 18, 2017

First Submitted That Met QC Criteria

December 21, 2017

First Posted (ACTUAL)

January 2, 2018

Study Record Updates

Last Update Posted (ACTUAL)

December 24, 2020

Last Update Submitted That Met QC Criteria

December 23, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ITI-214-104

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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