A Phase 1 interventional study of Arm 1 - GEH120714 (18F) Injection in Relapsing-remitting Multiple Sclerosis (rrMS), sponsored by GE Healthcare. Completed at 1 site in Canada. Open to participants aged 20 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-02-24.
Sponsored by GE Healthcare · Phase 1, Interventional, and Other
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.
615 studies on the registry are indexed under Multiple Sclerosis, Relapsing-Remitting; 80 are open to participants now.
This study's planned enrollment of 30 is below the median of 72 across 437 interventional studies indexed under Multiple Sclerosis, Relapsing-Remitting.
Browse Multiple Sclerosis, Relapsing-Remitting studies →GE Healthcare is the lead sponsor of 176 studies on the registry; 21 are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 16 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
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).
Drug: Arm 1 - GEH120714 (18F) Injection
Intervention is to administer GEH120714 (18F) Injection (100-270 Megabecquerel (MBq), single intravenous administration).
Also known as: GEH120714 (18F)
Recording 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.
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 for up to 24 hours for safety monitoring post contrast administration.
Blood samples collected multiple periods post injection; and urine samples at periods post injection to count radioactivity to determine bio-distribution, internal radiation dosimetry and Effective Dose (E) in healthy volunteers (HV).
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).
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,
This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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Multiple Sclerosis, Relapsing-Remitting →