Healthy
Conditions
Keywords
Positron Emission Tomography, Serotonin, 5-HT2A, Radioligand, Radiation dosimetry, Radiation dosage
Brief summary
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
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.
Interventions
DRUG[11C]Cimbi-36
DRUG[11C]Cimbi-36-5
Sponsors
Gitte Moos Knudsen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effective dose and absorbed dose for selected organs | 0 - 120 minutes | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of radioactive metabolites in plasma | 0 - 120 minutes | 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). |
| Measurement of radioactivity in plasma and whole blood | 0 - 120 minutes | 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). |
Countries
Denmark
Outcome results
None listed