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Completed

NCT Number: NCT01738347

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).

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.

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Key information

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

St. Joseph Healthcare

Hamilton, Ontario, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Arm 1 - GEH120714 (18F) Injection

Drug

Intervention is to administer GEH120714 (18F) Injection (100-270 Megabecquerel (MBq), single intravenous administration).

Other names: GEH120714 (18F)

Primary outcomes

  1. 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 outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

GE Healthcare

Industry

Collaborators

  • Centre for Probe Development and Commercialization

Registry information

Official study title

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)

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Nov 30, 2012
Registry last updated
Feb 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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