Open-label, Non-randomized Study to Assess Safety, Bio-distribution, and Radiation Dosimetry, and Optimize the 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 May 2015 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: May 26, 2015
Last verified: May 2015
  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:
  • 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 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:
  • 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 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, ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 30
Study Start Date: April 2013
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 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.
  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
Canada, Ontario
St. Joseph Healthcare Recruiting
Hamilton, Ontario, Canada
Contact: Angela Besanger    905-525-9140    abesanger@imagingprobes.ca   
Contact: Anne Goodbody    905-525-9140    goodbody@imagingprobes.ca   
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: May 26, 2015
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 July 01, 2015