Ignite Creation Date:
2024-07-17 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06476509
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-06-18
Brief Title:
A Study to Assess Serotonin Transporter Occupancy of Healthy Adults Using 11C-DASB PET
Sponsor:
Vigonvita Life Sciences
Organization:
Vigonvita Life Sciences
Study Overview
Official Title:
A Non-Randomized Open-Label Exploratory Mechanistic Validation PoM Clinical Trial of LV232 Capsule Assessing Serotonin Transporter Occupancy in the Healthy Adult Brain Using 11C-DASB Positron Emission Tomography PET
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
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:
This study was a non-randomized open-label clinical study to assess Serotonin transporter occupancy in the brain of healthy adults using 11C-DASB positron emission tomography PET
Detailed Description:
This study was a non-randomized open-label clinical study to assess Serotonin transporter occupancy in the brain of healthy adults using 11C-DASB positron emission tomography PETLV232 capsules were administered as single oral doses of 40mg and the PET scans were performed at screening and about 3h after administration The positive drug group escitalopram was established at a single dosing of 20mg based on an evaluation of the occupancy obtained data from LV232 capsule cohorts
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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