[11C]Cimbi-36 Dosimetry

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: [11C]Cimbi-36-5; Drug: [11C]Cimbi-36

• Registration Number: NCT02629003
• Lead Sponsor: Gitte Moos Knudsen

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.

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2015-12-07
• Study First Submitted QC: 2015-12-09
• Study First Posted: 2015-12-11
• Primary Completion: 2018-10-10
• Study Completion: 2018-10-10
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-25
• Last Update Posted: 2019-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Neurobiology Research Unit, Rigshospitalet; 🇩🇰 Copenhagen, Denmark