Ignite Creation Date:
2025-12-24 @ 5:45 PM
Ignite Modification Date:
2026-02-25 @ 8:48 PM
Study NCT ID:
NCT03082768
Status:
COMPLETED
Last Update Posted:
2018-03-06
First Post:
2017-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 0 Study of [18F]MNI-968 as a Marker for D1 Receptor in Healthy Subjects
Sponsor:
Molecular NeuroImaging
Organization:
Study Overview
Official Title:
An Open Label, Brain Positron Emission Tomography, Phase 0 Study of [18F]MNI-968 as a Marker for D1 Receptor in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2018-03
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 overall goal of this protocol is to evaluate \[18F\]MNI-968 (aka PF-06730110) as a D1 receptor targeted radiopharmaceutical.
Detailed Description:
The overall goal of this protocol is to evaluate \[18F\]MNI-968 (aka PF-06730110) as a D1 receptor targeted radiopharmaceutical.
* To measure the dynamic uptake and washout of \[18F\]MNI-968 in brain using positron emission tomography (PET) in healthy volunteers.
* To measure blood metabolites of \[18F\]MNI-968 in the healthy volunteers and to perform invasive as well as non-invasive modeling to assess \[18F\]MNI-968 binding to D1 receptor.
* To acquire safety data following injection of \[18F\]MNI-968
* Evaluation of \[18F\]MNI-968 PET reliability (test/retest) of several outcome measures
* To measure the dynamic uptake and washout of \[18F\]MNI-968 in brain using positron emission tomography (PET) in healthy volunteers.
* To measure blood metabolites of \[18F\]MNI-968 in the healthy volunteers and to perform invasive as well as non-invasive modeling to assess \[18F\]MNI-968 binding to D1 receptor.
* To acquire safety data following injection of \[18F\]MNI-968
* Evaluation of \[18F\]MNI-968 PET reliability (test/retest) of several outcome measures
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?: