Study Evaluating the Safety of Myeliviz Myelin-Targeting PET Agent

NCT04333290 | Withdrawn Early Phase 1 FDA Drug

• 1 other identifier: MeDAS-001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the safety of \[11C\]MeDAS, a PET radiotracer.

Conditions

Healthy

Keywords

myelin; PET; central nervous system; brain; spinal cord; demyelination; MRI

Outcome Measures

Primary Outcomes (5)

• Radiation dosimetry

  Whole body radiotracer uptake, as measured using PET scan image data. Radiotracer uptake will be measured in absolute counts and using distribution volume ratios.

  Less than or equal to 2 hours

• Biodistribution analysis

  Organ-specific radiotracer uptake, as measured using PET scan image data. Radiotracer uptake will be measured in absolute counts and using distribution volume ratios.

  Less than or equal to 2 hours

• Metabolism analysis

  Analysis of in vivo radiotracer metabolism using liquid chromatography, with quantification of relative peak areas under the curve.

  Less than or equal to 2 hours

• Pharmacokinetic analysis based on PET scan data

  Determination of time-dependent radiotracer distribution using PET scan image data, with time measurement in minutes, PET data measured in absolute counts, and position in the body determined by organ segmentation.

  Less than or equal to 2 hours

• Analysis of time-dependent radiotracer distribution based on arterial blood sampling

  Determination of time-dependent radiotracer distribution as assessed by arterial blood sampling, using scintillation counting for determination of radiotracer activity. Time is measured in minutes and radiotracer quantity is assayed by scintillation counting with units in absolute counts.

  Less than or equal to 2 hours

Secondary Outcomes (2)

• Brain imaging characterization

  Less than or equal to 2 hours

• Spinal cord imaging characterization

  Less than or equal to 2 hours

Study Arms (1)

Single Arm: Healthy subjects

EXPERIMENTAL

The PET radiotracer Myeliviz (\[11C\]MeDAS) will be administered to healthy subjects twice and PET scans will be obtained each time. This will allow assessment of the PET image quality, PET scan reproducibility and radiotracer distribution.

Drug: [11C]MeDAS

Interventions

[11C]MeDAS DRUG

PET radiotracer

Also known as: Myeliviz

Single Arm: Healthy subjects

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject reports no known physical diseases of the central nervous system including no history of mental health disorders.
• Capable of giving informed consent
• Efforts will be made to include approximately equal numbers of women and men. Efforts will be made to include individuals of diverse ethnicities, as reflected in the local clinic population.

You may not qualify if:

• Age \<18 or \>65
• History of malignant hypertension or hypertensive crisis
• Known infectious disease requiring treatment during the course of the study
• Subject reported history of substance abuse
• inability to undergo an MRI or PET scan

Sponsors & Collaborators

• Robert Fox: lead
• Case Western Reserve University: collaborator

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Demyelinating Diseases

Interventions

N-methyl-4,4'-diaminostilbene

Condition Hierarchy (Ancestors)

Nervous System Diseases

Study Officials

• Robert Fox, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vice Chair, Research

Study Record Dates

• First Submitted: March 18, 2020
• First Posted: April 3, 2020
• Study Start: July 24, 2024
• Primary Completion: July 25, 2024
• Study Completion: July 25, 2024
• Last Updated: February 17, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)