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| Name | Class |
|---|---|
| Centre for Probe Development and Commercialization | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 - GEH120714 (18F) Injection | Experimental | Intervention is to administer GEH120714 (18F) Injection (100-270 Megabecquerel (MBq), single intravenous administration). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arm 1 - GEH120714 (18F) Injection | Drug | Intervention is to administer GEH120714 (18F) Injection (100-270 Megabecquerel (MBq), single intravenous administration). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). |
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Inclusion Criteria:
Inclusion Criteria for all Participants:
Inclusion Criteria for all healthy volunteers:
Inclusion Criteria specific for participants with relapsing and remitting results sclerosis (rrMS):
Exclusion Criteria:
General Exclusion Criteria for all participants:
Exclusion Criteria specific for healthy volunteers:
Exclusion Criteria specific for participants with remitting multiple sclerosis (rrMS):
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| Name | Affiliation | Role |
|---|---|---|
| Paul Sherwin, M.D. | GE Healthcare | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Joseph Healthcare | Hamilton | Ontario | Canada |
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|
| 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, |
| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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