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RECRUITING Phase 1

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

NCT06299410 · View on ClinicalTrials.gov ↗

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.

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

Sponsor

Intra-Cellular Therapies

54 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06299410

The ClinicalTrials.gov registry entry for NCT06299410 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Intra-Cellular Therapies, which has 54 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06299410 reports 1 study location spanning 1 distinct geographic area — top geographies include Connecticut. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06299410?

The interventions under investigation include: ITI-1284 10 mg (DRUG), ITI-1284 20 mg (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06299410?

This trial is sponsored by Intra-Cellular Therapies, which has 54 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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