NCT06299410

PET Study to Evaluate Brain Receptor Occupancy, Safety and Pharmacokinetics of ITI-1284 in Healthy Subjects

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: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Intra-Cellular Therapies, Inc. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The study will be conducted as an open-label and single-center study to evaluate the occupancy of ITI-1284 to the dopamine D2 receptor, serotonin 2A (5-HT2A) receptor, and serotonin transporter (SERT) in healthy subjects.

Detailed description

This study consists of up to 3 sequential parts. Part A will evaluate the D2 receptor occupancy for ITI-1284 at two dose levels. Part B will evaluate the 5HT-2A receptor and SERT occupancy for ITI-1284 at one dose level. Part C (optional) will evaluate the time course of receptor occupancy of ITI-1284 on the D2 or 5-HT2A receptor at one dose level.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	ITI-1284 10 mg	ITI-1284 tablet
DRUG	ITI-1284 20 mg	ITI-1284 tablet

Timeline

• Start date: 2024-04-11
• Primary completion: 2025-09-01
• Completion: 2025-09-01
• First posted: 2024-03-07
• Last updated: 2025-01-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study