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Assessment of the Biodistribution and Safety of [18F]MNI-968 in Healthy Subjects

Phase 1
Completed
Conditions
Healthy Volunteers
Interventions
Registration Number
NCT03142724
Lead Sponsor
Molecular NeuroImaging
Brief Summary

The overall goal of this protocol is to evaluate the biodistribution of \[18F\]MNI-968 as a D1 receptor targeted radiopharmaceutical.

Detailed Description

The overall goal of this protocol is to evaluate the biodistribution of \[18F\]MNI-968 as a D1 receptor targeted radiopharmaceutical. The specific objectives are:

* To determine the radiation dosimetry of \[18F\]MNI-968

* To assess the safety and tolerability of a single dose of \[18F\]MNI-968

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
6
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
[18F]MNI-968[18F]MNI-968To assess the safety and tolerability and to determine the radiation dosimetry of \[18F\]MNI-968.
Primary Outcome Measures
NameTimeMethod
Whole body tomographic PET images will be obtained for 6 healthy volunteers, and reviewed visually for assessment of body organ distribution of radioactivity.2 Months

Volumes of interest (VOI) will be placed on the visually identified source organs, and subsequently used for all the study PET frames. Activity within these volumes of interest is expressed in units of total radioactivity (kBq). Radioactivity will be corrected for body attenuation, but not for decay, and time activity data (TAC) generated for each source organ.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Molecular NeuroImaging, LLC

🇺🇸

New Haven, Connecticut, United States

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