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NCT06299410 · ClinicalTrials.gov registry record · Phase 1

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

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

Recruiting
Registry status
Phase 1
Development phase
30
Enrollment target
1
Study location

NCT06299410: Recruiting Phase 1 study of Healthy Volunteers, sponsored by Intra-Cellular Therapies.

NCT06299410 is a Phase 1 study of Healthy Volunteers that is actively recruiting participants, run by Intra-Cellular Therapies. The registered enrollment target is 30 participants, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06299410, a Phase 1 study of Healthy Volunteers, is actively recruiting participants, sponsored by Intra-Cellular Therapies.

RECRUITING
Registry status
Phase 1
Development phase
30 participants
Enrollment target
1
Study location

Study 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.

Primary Outcome

Percent change of binding potential from baseline

Conditions Studied

Interventions

  • DRUG ITI-1284 10 mg
  • DRUG ITI-1284 20 mg

Study Locations (1)

Connecticut

  • Clinical Site 1 - New Haven

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2024-04-11
Est. Completion 2025-09
Phase Phase 1
Intra-Cellular Therapies

37 total trials

What NCT06299410 shows while recruiting

NCT06299410 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (94% lower).

The record links to 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 2 interventions - of which ITI-1284 10 mg is the first listed.

NCT06299410 reports a single indexed study location in Connecticut.

Frequently Asked Questions

What is clinical trial NCT06299410 about?

NCT06299410 is a clinical study titled "PET Study to Evaluate Brain Receptor Occupancy, Safety and Pharmacokinetics of ITI-1284 in Healthy Subjects". 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.

What is the current status of trial NCT06299410?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2024-04-11. Estimated completion is 2025-09.

What conditions does trial NCT06299410 study?

This clinical trial studies the following conditions: Healthy Volunteers.

What interventions are being tested in trial NCT06299410?

The interventions under investigation include: ITI-1284 10 mg (DRUG), ITI-1284 20 mg (DRUG).

Who is sponsoring clinical trial NCT06299410?

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

Where is trial NCT06299410 being conducted?

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

Similar trials for Healthy Volunteers

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06299410's enrollment target sits among peer trials

30 187th of 283 higher than 87 of 283 other Healthy Volunteers trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Healthy Volunteers trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06299410, the US trial registry maintained by the National Library of Medicine. NCT06299410 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.