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).

NCT01738347 | Completed Phase 1 DMC

• 1 other identifier: GE-180-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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)

Outcome Measures

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.

  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.

  Time zero equals the date of contrast imaging and for up to 24 hours for safety monitoring post contrast administration.

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 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,

Study Arms (1)

Arm 1 - GEH120714 (18F) Injection

EXPERIMENTAL

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

Drug: Arm 1 - GEH120714 (18F) Injection

Interventions

Arm 1 - GEH120714 (18F) Injection DRUG

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

Also known as: GEH120714 (18F)

Arm 1 - GEH120714 (18F) Injection

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• GE Healthcare: lead
• Centre for Probe Development and Commercialization: collaborator

Study Sites (1)

St. Joseph Healthcare

Hamilton, Ontario, Canada

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

Injections

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Paul Sherwin, M.D.

  GE Healthcare

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2012
• First Posted: November 30, 2012
• Study Start: April 1, 2013
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: February 24, 2017

Record last verified: 2017-02

Locations

CA (1)