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NCT02629003 Clinical Trial

[11C]Cimbi-36 Dosimetry

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02629003
Other study ID # H-15001910
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date December 2015
Est. completion date October 10, 2018

Study information
Verified date March 2019
Source Rigshospitalet, Denmark
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 8
Est. completion date October 10, 2018
Est. primary completion date October 10, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• [11C]Cimbi-36

• [11C]Cimbi-36-5

Locations
Country Name City State
Denmark Neurobiology Research Unit, Rigshospitalet Copenhagen

Sponsors (1)
Lead Sponsor Collaborator
Gitte Moos Knudsen

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
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