Assess Safety, Bio-distribution, Dosimetry, and Optimize Imaging Protocol of GEH120714 (18F) Injection, in Healthy Volunteers and Participants With Relapsing and Remitting Multiple Sclerosis (rrMS)



Status:Completed
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:20 - 50
Updated:7/11/2015
Start Date:December 2012
End Date:December 2015
Contact:Angela Besanger
Email:abesanger@imagingprobes.ca
Phone:905-525-9140

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A Phase 1, Open-label, Non-randomized Study to Assess Safety, Bio-distribution, and Radiation Dosimetry, and Optimize the Imaging Protocol of GEH120714 (18F) Injection, a Marker of Microglial Activation, in Healthy Volunteers and Participants With Relapsing and Remitting Multiple Sclerosis (rrMS)

To evaluate the safety, bio-distribution, and radiation dosimetry; and to optimize the
Imaging Protocol of GEH120714 (18F) Injection. Study recruits healthy volunteers and
participants with relapsing and remitting multiple sclerosis.


Inclusion Criteria:

Inclusion Criteria for all Participants:

- The subject has a clinically normal or acceptable medical history and physical
examination at screening.

- The subject has an acceptable kidney function (eGFR >60 mL/min/1.73m2) for
administration of Gadolinium.

- The subject has a trans-locator protein (TSPO) platelet assay conducted / genotype
screen within the past 3 months and is a high or mixed affinity GE-180 binder.

Inclusion criteria specific for healthy volunteers:

- The subject has no clinical history or signs of neurological impairment.

- The subject has a normal MRI without central white matter lesions.

Inclusion criteria specific for participants with relapsing and remitting multiple
sclerosis (rrMS):

- The subject meets McDonald criteria for relapsing remitting multiple sclerosis.

- The subject at screening has at least two central white matter plaques evident on
MRI.

- The subject at screening has a MRI scan of sufficient quality for Volume of Interest
(VOI) definition and co-alignment with Positron Emission Tomography (PET).

Exclusion Criteria:

General Exclusion Criteria for all participants:

- The subject has a contraindication for Magnetic Resonance Imaging (MRI).

- The subject has known allergies to Gadolinium contrast agent.

- The subject has received significant ionising radiation exposure from clinical trials
or medical examinations in the last 12 months.

Exclusion Criteria specific for healthy volunteers:

- The subject has family history of multiple sclerosis (MS).

- The subject is undergoing monitoring of occupational ionising radiation exposure.

Exclusion Criteria specific for participants with remitting multiple sclerosis (rrMS):

- The subject has a past history of cerebrovascular disease or vasculitis.

- The subject has a history of head injury with prolonged coma.
We found this trial at
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Princeton, New Jersey 08540
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