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An Open-label, Positron Emission Tomography Study to Evaluate Brain Receptor Occupancy, Safety, Tolerability, and Pharmacokinetics After a Single Sublingual Administration of ITI-1284 in Healthy Subjects

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Trial Profile

An Open-label, Positron Emission Tomography Study to Evaluate Brain Receptor Occupancy, Safety, Tolerability, and Pharmacokinetics After a Single Sublingual Administration of ITI-1284 in Healthy Subjects

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 03 Feb 2025

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At a glance

  • Drugs Lumateperone (Primary)
  • Indications Agitation
  • Focus Pharmacokinetics
  • Sponsors Intra-Cellular Therapies

Most Recent Events

  • 24 Jan 2025 Planned number of patients changed from 12 to 30.
  • 24 Jan 2025 Planned End Date changed from 1 Mar 2025 to 1 Sep 2025.
  • 24 Jan 2025 Planned primary completion date changed from 1 Mar 2025 to 1 Sep 2025.

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