[11C]Cimbi-36 Dosimetry

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluation of Radiation Dose for [11C]Cimbi-36

Conditions
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Healthy

Intervention / Treatment
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* Drug: [11C]Cimbi-36
* Drug: [11C]Cimbi-36-5


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age Signed informed consent Exclusion Criteria: Present or former neurological disease, severe somatic or psychiatric disease, or medication thet can interfere with the test results. Pregnancy at the time of the scan Breastfeeding Alcohol or substance abuse Exposure to radiation (>10 millisievert (mSv)) within the last year, or significant exposure at work Allergy to any of the substances in the Investigational medicinal product (IMP) formulation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: [11C]Cimbi-36<br>[11C]Cimbi-36 Maximum of 600 Mega Becquerel (MBq) or 1.5 micrograms, single dose intravenous (I.V.) | Drug: [11C]Cimbi-36<br> <br> |
| Active Comparator: [11C]Cimbi-36-5<br>[11C]Cimbi-36-5 Maximum of 600 Mega Becquerel (MBq) or 1.5 micrograms, single dose intravenous (I.V.) | Drug: [11C]Cimbi-36-5<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Positron Emission Tomography, Serotonin, 5-HT2A, Radioligand, Radiation dosimetry, Radiation dosage