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NCT03489772 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Healthy Volunteers, sponsored by Intra-Cellular Therapies.

Completed
Registry status
Phase 1
Development phase
26
Enrollment target
1
Study location

NCT03489772 is a Phase 1 study of Healthy Volunteers that has completed, run by Intra-Cellular Therapies. The registered enrollment target is 26 participants, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03489772, a Phase 1 study of Healthy Volunteers, has completed, sponsored by Intra-Cellular Therapies.

COMPLETED
Registry status
Phase 1
Development phase
26 participants
Enrollment target
1
Study location

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 Studied

Interventions

  • DRUG Placebo
  • DRUG ITI-214

Study Locations (1)

Oklahoma

  • Laureate Institute for Brain Research, Inc. - Tulsa

Trial Details

FieldValue
Enrollment Target 26 participants
Start Date 2018-07-10
Est. Completion 2019-08-05
Phase Phase 1

Sponsor

Intra-Cellular Therapies

37 total trials

What the Registry Record Tells You About NCT03489772

The ClinicalTrials.gov registry entry for NCT03489772 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (95% lower). The listed sponsor is Intra-Cellular Therapies, which has 37 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT03489772 reports 1 study location spanning 1 distinct geographic area - top geographies include Oklahoma.

Frequently Asked Questions

What is clinical trial NCT03489772 about?

NCT03489772 is a clinical study titled "Study of ITI-214 in Healthy Volunteers to Determine CNS Engagement". 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 als...

What is the current status of trial NCT03489772?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2018-07-10. Estimated completion is 2019-08-05.

What conditions does trial NCT03489772 study?

This clinical trial studies the following conditions: Healthy Volunteers.

What interventions are being tested in trial NCT03489772?

The interventions under investigation include: Placebo (DRUG), ITI-214 (DRUG).

Who is sponsoring clinical trial NCT03489772?

This trial is sponsored by Intra-Cellular Therapies, which has 37 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03489772 being conducted?

This trial has 1 study location across Oklahoma. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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