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 |
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.
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
1
site
Click here to add this to my saved trials
