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).

NCT ID: NCT01738347

Last Updated: 2017-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2016-05-31

Brief Summary

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.

Conditions

Relapsing-remitting Multiple Sclerosis (rrMS)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Arm 1 - GEH120714 (18F) Injection

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

Group Type: EXPERIMENTAL

Arm 1 - GEH120714 (18F) Injection

Intervention Type: DRUG

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

Interventions

Arm 1 - GEH120714 (18F) Injection

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

Intervention Type: DRUG

Other Intervention Names

GEH120714 (18F)

Eligibility Criteria

Inclusion Criteria

• 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.

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

• 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

• 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.

• The subject has family history of multiple sclerosis (MS).
• The subject is undergoing monitoring of occupational ionising radiation exposure.

• The subject has a past history of cerebrovascular disease or vasculitis.
• The subject has a history of head injury with prolonged coma.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centre for Probe Development and Commercialization

OTHER

Sponsor Role: collaborator

GE Healthcare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul Sherwin, M.D.

Role: STUDY_DIRECTOR

GE Healthcare

Locations

St. Joseph Healthcare

Hamilton, Ontario, Canada

Countries

Canada

Other Identifiers

GE-180-001

Identifier Type: -

Identifier Source: org_study_id