[11C]Cimbi-36 Dosimetry

Gitte Moos Knudsen

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: [11C]Cimbi-36; Drug: [11C]Cimbi-36-5

Study type: Interventional

Funder types: Other

Identifiers

NCT02629003

H-15001910

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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8 participants in 2 patient groups

[11C]Cimbi-36

Active Comparator group

Description:

\[11C\]Cimbi-36 Maximum of 600 Mega Becquerel (MBq) or 1.5 micrograms, single dose intravenous (I.V.)

Treatment:

Drug: [11C]Cimbi-36

[11C]Cimbi-36-5

Active Comparator group

Description:

\[11C\]Cimbi-36-5 Maximum of 600 Mega Becquerel (MBq) or 1.5 micrograms, single dose intravenous (I.V.)

Treatment:

Drug: [11C]Cimbi-36-5