drugset / Trial / NCT03257046

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ITI-214 in Parkinson's Disease

NCT03257046 ↗

Phase 1/2 Completed 40 enrolled Intra-Cellular Therapies, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a Phase I/II randomized, double-blind, placebo-controlled, multiple rising dose study in patients with stable idiopathic Parkinson's disease (PD) to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ITI-214.

Timeline

Start
2017-09-28
Primary completion
2018-09-06
Completion
2018-09-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Lenrispodun Small molecule 1 mg Oral
Subject Lenrispodun Small molecule 3 mg Oral
Subject Lenrispodun Small molecule 10 mg Oral
Subject Lenrispodun Small molecule 30 mg Oral
Subject Lenrispodun Small molecule 90 mg Oral

Indications