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Assess Safety, Bio-distribution, Dosimetry, and Optimize Imaging Protocol of GEH120714 (18F) Injection, in Healthy Volunteers and Participants With Relapsing and Remitting Multiple Sclerosis (rrMS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by GE Healthcare
Sponsor:
Collaborator:
Centre for Probe Development and Commercialization
Information provided by (Responsible Party):
GE Healthcare
ClinicalTrials.gov Identifier:
NCT01738347
First received: November 13, 2012
Last updated: October 7, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Evaluate the Safety of GEH120714 (18F) Injection in Healthy Volunteers (HV) and Participants With rrMS.
Drug: Arm 1 - GEH120714 (18F) Injection
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Phase 1, Open-label, Non-randomized Study to 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)

Resource links provided by NLM:


Further study details as provided by GE Healthcare:

Primary Outcome Measures:
  • Record the occurrence of adverse events (AEs) to evaluate the safety of a single dose of GEH120714 (18F) Injection [ Time Frame: Time zero equals the date of contrast imaging and for up to 24 hours for safety monitoring post contrast administration. ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • Collect blood samples to count radioactivity levels to determine the bio-distribution, internal radiation dosimetry and Effective Dose. [ Time Frame: Blood samples taken at 30 and 120 minutes post the drug injection. ] [ Designated as safety issue: No ]
    Collect blood samples at 30 and 120 minutes post drug injection to count radioactivity to determine the bio-distribution, internal radiation dosimetry and Effective Dose (E) of [18F]GEH120714 following intravenous (iv.) administration in healthy volunteers (HVs).

  • Collect urine samples to count radioactivity levels to determine the bio-distribution, internal radiation dosimetry and Effective Dose. [ Time Frame: Urine samples taken at 90, 180 and 300 minutes post the drug injection. ] [ Designated as safety issue: No ]
    Collect urine samples at 90, 180 and 300 minutes post drug injection to count radioactivity to determine the bio-distribution, internal radiation dosimetry and Effective Dose (E) of [18F]GEH120714 following intravenous (iv.) administration in healthy volunteers (HVs).


Estimated Enrollment: 30
Study Start Date: December 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: GEH120714 (18F)

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 / genotype screen within the past 3 months and is a high or mixed affinity GE-180 binder.

Inclusion criteria specific for healthy volunteers:

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

Inclusion criteria specific for participants with relapsing and remitting multiple sclerosis (rrMS):

  • The subject meets McDonald criteria for relapsing remitting multiple sclerosis.
  • The subject at screening has at least two central white matter plaques evident 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01738347

Contacts
Contact: Angela Besanger 905-525-9140 ext 21357 abesanger@imagingprobes.ca

Locations
United States, New Jersey
GE Healthcare Recruiting
Princeton, New Jersey, United States, 08540
Contact: Angela Besanger    905-525-9140    abesanger@imagingprobes.ca   
Contact: Anne Goodbody    905-525-9140    goodbody@imagingprobes.ca   
Canada, Ontario
St. Joseph Healthcare, Subject Recruitment Site Recruiting
Hamilton, Ontario, Canada, L8N4A6
Contact: Angela Besanger    908-525-9140 ext 21357    abesanger@imagingprobes.ca   
Contact: Anne Goodbody    905-525-9140    Goodbody@imagingprobes.ca   
Sponsors and Collaborators
GE Healthcare
Centre for Probe Development and Commercialization
Investigators
Study Director: Paul Sherwin, M.D. GE Healthcare
  More Information

No publications provided

Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT01738347     History of Changes
Other Study ID Numbers: GE-180-001
Study First Received: November 13, 2012
Last Updated: October 7, 2014
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Multiple Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on November 20, 2014