Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06299410
Status:
RECRUITING
Last Update Posted:
2024-05-03
First Post:
2024-03-01
Brief Title:
PET Study to Evaluate Brain Receptor Occupancy Safety and Pharmacokinetics of ITI-1284 in Healthy Subjects
Sponsor:
Intra-Cellular Therapies Inc
Organization:
Intra-Cellular Therapies Inc
Study Overview
Official Title:
An Open-label Positron Emission Tomography Study to Evaluate Brain Receptor Occupancy Safety Tolerability and Pharmacokinetics After a Single Sublingual Administration of ITI-1284 in Healthy Subjects
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 in healthy subjects Subjects will enroll in one of the 2 cohorts will have a baseline PETCT scan will receive a single dose of ITI-1284 and undergo one postdose PETCT scan
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None