drugset / Trial / NCT03387215

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

NCT03387215 ↗

Phase 1/2 Completed 36 enrolled Intra-Cellular Therapies, Inc.
RandomizedSequentialQuadruple-blindTreatment

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.

Timeline

Start
2018-07-10
Primary completion
2020-03-16
Completion
2020-03-16

Drugs

EvaluationDrugModalityDoseRoute
Subject Lenrispodun Small molecule 10 mg Oral
Subject Lenrispodun Small molecule 30 mg Oral
Subject Lenrispodun Small molecule 75 mg Oral
Subject Lenrispodun Small molecule 150 mg Oral