St. Joseph Healthcare
Hamilton, Ontario, Canada
NCT Number: NCT01738347
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.
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Notify Me20 year–50 year
All sexes
Interventional
Phase 1
Hamilton, Ontario, Canada
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Inclusion criteria
for all Participants:
Inclusion criteria
for all healthy volunteers:
Inclusion criteria
specific for participants with relapsing and remitting results sclerosis (rrMS):
Exclusion criteria
General Exclusion Criteria for all participants:
Exclusion criteria
specific for healthy volunteers:
Exclusion criteria
specific for participants with remitting multiple sclerosis (rrMS):
Intervention is to administer GEH120714 (18F) Injection (100-270 Megabecquerel (MBq), single intravenous administration).
Other names: GEH120714 (18F)
Time frame: Time zero equals the date of contrast imaging and for up to 24 hours for safety monitoring post contrast administration.
Record the occurrence of adverse events (AEs) to evaluate the safety of a single dose of GEH120714 (18F) Injection in healthy volunteers (HV) and participants with rrMS.
Time frame: Time zero equals the date of contrast imaging and up to the evaluation of the images and the kinetic modelling of cerebral uptake of GEH120714 (18F) Injection,
Collect blood samples at multiple time periods up to 120 minutes post drug injection; and urine samples at multiple time periods up to 270 minutes post drug injection to count radioactivity to determine the bio-distribution, internal radiation dosimetry and Effective Dose (E) per protocol in healthy volunteers (HV).
GE Healthcare
Industry
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)
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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