NCT03387215

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 18, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 2, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

July 10, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 16, 2020

Completed
Last Updated

December 24, 2020

Status Verified

December 1, 2020

Enrollment Period

1.7 years

First QC Date

December 18, 2017

Last Update Submit

December 23, 2020

Conditions

Heart Failure, Systolic

Outcome Measures

Primary Outcomes (1)

  • Echocardiogram with Doppler imaging and hemodynamic monitoring

    Cardiac systolic and diastolic function

    2 hours

Secondary Outcomes (3)

  • 12-lead electrocardiogram (ECG)

    2 hours

  • Hemodynamic monitoring

    5-6 hours

  • Number of patients with treatment-emergent adverse events

    5 days

Other Outcomes (1)

  • Plasma and urine levels of cAMP and cGMP as Exploratory biomarkers

    2 hours

Study Arms (4)

10 mg ITI-214

EXPERIMENTAL

Single oral dose

Drug: ITI-214

30 mg ITI-214

EXPERIMENTAL

Single oral dose

Drug: ITI-214

75 mg - 150 mg ITI-214

EXPERIMENTAL

Single oral dose

Drug: ITI-214

Placebo

PLACEBO COMPARATOR

Single oral dose

Other: Placebo

Interventions

ITI-214DRUG

Oral

10 mg ITI-21430 mg ITI-21475 mg - 150 mg ITI-214
PlaceboOTHER

Oral

Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • NYHA class II-III heart failure
  • Ejection fraction equal to or below 35%
  • On stable heart failure drug treatment

You may not qualify if:

  • Considered medically inappropriate for study participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Duke Clinical Research Institute

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

  • 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.

    PMID: 34461742DERIVED

MeSH Terms

Conditions

Heart Failure, Systolic

Interventions

ITI-214

Condition Hierarchy (Ancestors)

Heart FailureHeart DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2017

First Posted

January 2, 2018

Study Start

July 10, 2018

Primary Completion

March 16, 2020

Study Completion

March 16, 2020

Last Updated

December 24, 2020

Record last verified: 2020-12

Locations

US(2)