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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.
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
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2022-07-26 |
| Est. Completion | 2023-05-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗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.
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