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GEH120714

Phase 1

Relapsing-remitting Multiple Sclerosis (rrMS) | Small molecule | Neurology |GE HealthCare Technologies Inc.|Last Updated: Feb 24, 2017

Target and mechanism

ModalitySmall molecule

Also known as Arm 1 - GEH120714 (18F) Injection, Arm 1- GEH120714

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

GEH120714 · 1 trial · 1 indication

Phase 1 1
NCT01738347Assess Safety, Bio-distribution, Radiation Dosimetry and Optimize the Imaging Protocol of GEH120714 (18F) Injection in Healthy Volunteers and Participants With Relapsing and Remitting Multiple Sclerosis (rrMS).Relapsing-remitting Multiple Sclerosis (rrMS)
COMPLETED30 Analytics
PHASE1COMPLETED
Assess Safety, Bio-distribution, Radiation Dosimetry and Optimize the Imaging Protocol of GEH120714 (18F) Injection in Healthy Volunteers and Participants With Relapsing and Remitting Multiple Sclerosis (rrMS).
Relapsing-remitting Multiple Sclerosis (rrMS)
NCT0173834730
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Study Endpoints

Primary Endpoints

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.
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.

Secondary Endpoints

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).
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,
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeOTHER

Treatment Arms

ArmTypeDescription
Arm 1 - GEH120714 (18F) InjectionEXPERIMENTALIntervention is to administer GEH120714 (18F) Injection (100-270 Megabecquerel (MBq), single intravenous administration).

Interventions

NameTypeDescription
Arm 1 - GEH120714 (18F) InjectionDRUGIntervention is to administer GEH120714 (18F) Injection (100-270 Megabecquerel (MBq), single intravenous administration).
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Eligibility Criteria

Age Range20 Years to 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

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 tr...

Countries:Canada
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