[18F]-F13640 as a New Brain Radiopharmaceutical

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.

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Key information

Conditions

Neurological Pathology Healthy Subjects

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Early Phase 1

Primary location

Hospices Civils de Lyon

Bron, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

[18F]F13640

Drug

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

Primary outcomes

Binding potentials

Time frame: 180 minutes

Binding potentials are calculated using compartimental modelling techniques.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: F13640

Important dates

Study start: 2018
Primary completion: 2021
Study completion: 2021
First posted: Nov 20, 2017
Registry last updated: Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed