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NCT05470101 · ClinicalTrials.gov registry record · Phase 1

A PET Study Following a Single Oral Dose of ITI-333 in Healthy Subjects

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

Completed
Registry status
Phase 1
Development phase
12
Enrollment target

NCT05470101 is a Phase 1 study that has completed, run by Intra-Cellular Therapies. The registered enrollment target is 12 participants.

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The verdict

NCT05470101, a Phase 1 study, has completed, sponsored by Intra-Cellular Therapies.

COMPLETED
Registry status
Phase 1
Development phase
12 participants
Enrollment target

Study Summary

This is an open-label, single-dose study of up to 4 dose levels of ITI-333 in healthy male and female subjects. Each cohort will enroll 6 subjects. Subjects will have a baseline PET/CT scan and a postdose PET/CT scan using \[14C\]-MDL100907 to characterize 5-HT2A receptor occupancy

Interventions

  • DRUG ITI-333

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2022-07-26
Est. Completion 2023-05-03
Phase Phase 1

Sponsor

Intra-Cellular Therapies

37 total trials

What the Registry Record Tells You About NCT05470101

The ClinicalTrials.gov registry entry for NCT05470101 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Intra-Cellular Therapies, which has 37 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which ITI-333 is the first listed.

NCT05470101 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT05470101 about?

NCT05470101 is a clinical study titled "A PET Study Following a Single Oral Dose of ITI-333 in Healthy Subjects". This is an open-label, single-dose study of up to 4 dose levels of ITI-333 in healthy male and female subjects. Each cohort will enroll 6 subjects. Subjects will have a baseline PET/CT scan and a postdose PET/CT scan using \[14C\]-MDL100907 to characterize 5-HT2A receptor occupancy

What is the current status of trial NCT05470101?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2022-07-26. Estimated completion is 2023-05-03.

What interventions are being tested in trial NCT05470101?

The interventions under investigation include: ITI-333 (DRUG).

Who is sponsoring clinical trial NCT05470101?

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

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.