Trials / Completed
CompletedNCT05470101
A PET Study Following a Single Oral Dose of ITI-333 in Healthy Subjects
An Open-label, Positron Emission Tomography (PET) Study to Evaluate Brain Receptor Occupancy, Safety, Tolerability, and Pharmacokinetics After Single Oral Doses of ITI-333 in Healthy Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- Intra-Cellular Therapies, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ITI-333 | ITI-333 oral solution |
Timeline
- Start date
- 2022-07-26
- Primary completion
- 2023-05-03
- Completion
- 2023-05-03
- First posted
- 2022-07-22
- Last updated
- 2025-09-10
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05470101. Inclusion in this directory is not an endorsement.