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The purpose of this study is to determine the dosimetry for the Positron Emission Tomography (PET) tracer [11C]Cimbi-36 in two different Carbon-11 labelling positions. This information will contribute to determining whether [11C]Cimbi-36 can be optimized by changing the C-11 labelling position.
Healthy subjects wil undergo a whole-body Positron Emission Tomography (PET) scan with the Serotonin 2A Receptor (5-HT2A) radioligand [11C]Cimbi-36 or [11C]Cimbi-36-5 to determine the effective radiation dose and radiation dose for selected organs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [11C]Cimbi-36 | Active Comparator | [11C]Cimbi-36 Maximum of 600 Mega Becquerel (MBq) or 1.5 micrograms, single dose intravenous (I.V.) |
|
| [11C]Cimbi-36-5 | Active Comparator | [11C]Cimbi-36-5 Maximum of 600 Mega Becquerel (MBq) or 1.5 micrograms, single dose intravenous (I.V.) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [11C]Cimbi-36 | Drug |
| ||
| [11C]Cimbi-36-5 |
| Measure | Description | Time Frame |
|---|---|---|
| Effective dose and absorbed dose for selected organs | Based on the Positron Emission Tomography (PET) scan Time activity curves (TACs) will be generated and used for calculating the radiation doses for selected organs and over all effective radiation dose. | 0 - 120 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of radioactive metabolites in plasma | Venous blood samples will be used to measure radioactive metabolites and parent compound in the blood, using radio-High-performance liquid chromatography (HPLC). The parameters will be parent radioactivity and metabolite radioactivity as a fraction (unitless) of total radioactivity in plasma over time (unit = minutes). | 0 - 120 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gitte M Knudsen, MD, DMSc | Neurobiology Research Unit, Rigshospitalet | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neurobiology Research Unit, Rigshospitalet | Copenhagen | 2100 | Denmark |
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| ID | Term |
|---|---|
| C586246 | Cimbi-36 |
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|
| Measurement of radioactivity in plasma and whole blood | Venous blood samples will be used to measure radioactivity in plasma and whole blood. The measurement will be given as a ratio (unitless) of plasma radioactivity relative to whole blood radioactivity over time (unit = minutes). | 0 - 120 minutes |