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).

Overview

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.

Full Title of Study: “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)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2016

Interventions

  • Drug: Arm 1 – GEH120714 (18F) Injection
    • Intervention is to administer GEH120714 (18F) Injection (100-270 Megabecquerel (MBq), single intravenous administration).

Arms, Groups and Cohorts

  • Experimental: Arm 1 – GEH120714 (18F) Injection
    • Intervention is to administer GEH120714 (18F) Injection (100-270 Megabecquerel (MBq), single intravenous administration).

Clinical Trial Outcome Measures

Primary 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.
    • 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 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,
    • 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).

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • GE Healthcare
  • Collaborator
    • Centre for Probe Development and Commercialization
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Paul Sherwin, M.D., Study Director, GE Healthcare

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