NCT03082768

Phase 0 Study of [18F]MNI-968 as a Marker for D1 Receptor in Healthy Subjects

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
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Molecular NeuroImaging · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	[18F]MNI-968	Healthy volunteers recruited for the study will undergo two \[18F\]MNI-968 injections and PET scans.

Timeline

• Start date: 2017-03-03
• Primary completion: 2018-03-01
• Completion: 2018-03-01
• First posted: 2017-03-17
• Last updated: 2018-03-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study