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Study of ITI-214 in Healthy Volunteers to Determine CNS Engagement

NCT03489772 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2019-11-06

No results posted yet for this study

Summary

This is a single site, randomized, double-blind, placebo-controlled, within-subjects study design in healthy volunteers. Escalating single doses of ITI-214 will be evaluated using functional magnetic resonance imaging (fMRI) to determine central nervous system engagement. Safety and tolerability also will be assessed.

Conditions

  • Healthy Volunteers

Interventions

DRUG

ITI-214

Oral

DRUG

Placebo

Oral

Sponsors & Collaborators

  • Laureate Institute for Brain Research, Inc.

    collaborator OTHER

  • Intra-Cellular Therapies, Inc.

    lead INDUSTRY

Principal Investigators

  • Robert Davis, PhD · Intra-Cellular Therapies, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-07-10
Primary Completion
2019-08-05
Completion
2019-08-05
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03489772 on ClinicalTrials.gov