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

Intra-Cellular Therapies

Status and phase: Completed; Phase 2; Phase 1

Conditions: Heart Failure, Systolic

Treatments: Other: Placebo; Drug: ITI-214

Study type: Interventional

Funder types: Industry

Identifiers

NCT03387215

ITI-214-104

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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36 participants in 4 patient groups, including a placebo group

10 mg ITI-214

Experimental group

Description:

Single oral dose

Treatment:

Drug: ITI-214

30 mg ITI-214

Experimental group

Description:

Single oral dose

Treatment:

Drug: ITI-214

75 mg - 150 mg ITI-214

Experimental group

Description:

Single oral dose

Treatment:

Drug: ITI-214

Placebo

Placebo Comparator group

Description:

Single oral dose

Treatment:

Other: Placebo