Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2026-01-06 @ 12:02 PM
Study NCT ID:
NCT02824666
Status:
COMPLETED
Last Update Posted:
2017-07-17
First Post:
2016-06-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate D2 Receptor Occupancy Following Single Intravenous Administration of ATI-9242
Sponsor:
Braeburn Pharmaceuticals
Organization:
Study Overview
Official Title:
Phase 1, Open-Label Positron Emission Tomography (PET) Study to Evaluate D2 Receptor Occupancy Following Single Intravenous Administration of ATI-9242 in Adult Male Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2017-07
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 involves evaluating the occupancy of ATI-9242 at steady state at three different dose levels on D2 receptors in the brain using \[18F\] Fallypride PET in up to three cohorts of subjects.
Detailed Description:
This study involves evaluating the occupancy of ATI-9242 at steady state at three different dose levels on D2 receptors in the brain using \[18F\]Fallypride PET in up to three cohorts of subjects. The first dose evaluated will be 0.5 mg/kg administered as an IV bolus injection. The second dose that will be evaluated will be 1.0 mg/kg as an IV bolus injection. The safety and occupancy after each dose level will be evaluated prior to moving to the next dose. On two separate days, subjects will undergo \[18F\]Fallypride PET imaging sessions. The plasma concentration of ATI-9242 will be obtained prior to and during the course of the imaging session to allow determination of the relationship between plasma concentration of ATI-9242 with in vivo D2 occupancy.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: