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GEH120714

Phase 1

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

GEH120714 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

UNCONTROLLEDDMC
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

GEH120714 clinical trials

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)Unlock trial analytics

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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Frequently asked questions about GEH120714

What is GEH120714?

GEH120714 is an investigational small molecule imaging agent developed by GE HealthCare Technologies Inc. (ticker GEHC). It is being studied as an 18F-labeled injection for use in relapsing-remitting multiple sclerosis (rrMS). It is a Phase 1 candidate and has not been approved by the FDA.

What is GEH120714 used for in relapsing-remitting multiple sclerosis?

GEH120714 is being studied in relapsing-remitting multiple sclerosis (rrMS) as an imaging agent. The Phase 1 trial assessed its safety, bio-distribution, radiation dosimetry and imaging protocol in healthy volunteers and participants with rrMS. It is investigational and is not an approved treatment for rrMS.

Who makes GEH120714?

GEH120714 is developed by GE HealthCare Technologies Inc., which trades under the ticker GEHC. The company sponsored the Phase 1 study of the agent in healthy volunteers and participants with relapsing-remitting multiple sclerosis.

What phase is GEH120714 in?

GEH120714 is in Phase 1 development. Its only listed trial, NCT01738347, is a completed Phase 1 study. The drug is investigational and has not been approved by the FDA for any indication.

What clinical trials is GEH120714 in?

GEH120714 has been studied in one clinical trial, NCT01738347, a completed Phase 1 study titled to assess safety, bio-distribution, radiation dosimetry and imaging protocol optimization. It enrolled 30 participants, including healthy volunteers and people with relapsing-remitting multiple sclerosis, and was conducted in Canada.

Is GEH120714 the same as GEH120714 (18F) Injection?

Yes. GEH120714 is also referred to as GEH120714 (18F) Injection and Arm 1 - GEH120714 (18F) Injection. These names refer to the same investigational imaging agent developed by GE HealthCare Technologies Inc. for study in relapsing-remitting multiple sclerosis.