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).

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.

Study Overview

• Status: Completed
• Conditions: Relapsing-remitting Multiple Sclerosis (rrMS)
• Intervention / Treatment: Drug: Arm 1 - GEH120714 (18F) Injection

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada
      • St. Joseph Healthcare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 with documented results.

Inclusion Criteria for all healthy volunteers:

• The subject has no clinical history or signs of neurological impairment.
• The subject has a normal MRI without central white white matter lesions.

Inclusion Criteria specific for participants with relapsing and remitting results sclerosis (rrMS):

• Subject with a previous diagnosis of rrMS, presenting with (a) clinically active disease at time of screening or, or preferentially, (b) clinically active disease at time of screening and having at least one gadolinium--enhanced lesion 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Arm 1 - GEH120714 (18F) Injection; 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).; Other Names: GEH120714 (18F)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 zero equals the date of contrast imaging and for up to 24 hours for safety monitoring post contrast administration.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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,

Collaborators and Investigators

• Sponsor: GE Healthcare
• Collaborators: Centre for Probe Development and Commercialization

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (ACTUAL): May 1, 2016
• Study Completion (ACTUAL): May 1, 2016

Study Registration Dates

• First Submitted: November 13, 2012
• First Submitted That Met QC Criteria: November 29, 2012
• First Posted (ESTIMATE): November 30, 2012

Study Record Updates

• Last Update Posted (ACTUAL): February 24, 2017
• Last Update Submitted That Met QC Criteria: February 23, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Multiple Sclerosis, Relapsing-Remitting
• Other Study ID Numbers: GE-180-001