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NCT03347331 Clinical Trial

[18F]-F13640 as a New Brain Radiopharmaceutical

Healthy Subjects Clinical Trial

— F13640  

Official title:
First-in-man Study of [18F]-F13640, a PET Radiopharmaceutical for Functional 5-HT1A Receptor Imaging

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03347331
Other study ID # 69HCL16-0770
Secondary ID 2017-002722-21
Status Completed
Phase Early Phase 1
First received
Last updated
Start date April 23, 2018
Est. completion date December 2, 2021

Study information
Verified date April 2022
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This clinical assay is designed to validate that [18F]F13640 as a radiotracer of 5-HT1A functional receptors. A first group of healthy subjects underwent a PET scan with arterial blood sampling to determine the kinetic model of the tracer. A second group of healthy subjects underwent a classical test-retest study (i.e two distant PET scans) to determine the reproducibility of measures.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date December 2, 2021
Est. primary completion date April 23, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 20 Years to 45 Years
Eligibility Inclusion Criteria: - Healthy Subjects - Weight between 50 kg and 90 kg - Affiliated to a social security or similar scheme - Not subject to any legal protection measures Exclusion Criteria: Subjects with neurologic or psychiatric disease including all substance addictions - Daily smokers - Active infectious disease - MRI contraindications - PET contraindications determined with FDG injection - Subjects deprived of their liberty by judicial or administrative decision - Subjects unable to sign written consent for participation in the study. - Severe and progressive medical pathology - Volunteer who has exceeded the annual amount of compensation authorized for participation in research protocols

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• [18F]F13640
Radiotracer injection and PET scan acquisition of 90 min: *150 Mbq + 1 MBq/Kg of [18F]F13640 at t=0 min Arterial Blood Sampling during the 90min acquisition
• [18F]F13640
2 Radiotracer injections and PET scan acquisition of 90 min distant from 1 to 3 weeks: For each exam: 150 MBq + 1 MBq/kg of [18F]F13640 at t=0 min

Locations
Country Name City State
France Hospices Civils de Lyon Bron

Sponsors (1)
Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Binding potentials Binding potentials are calculated using compartimental modelling techniques. 180 minutes
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