[18F]-F13640 as a New Brain Radiopharmaceutical

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

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03347331

Acronym

F13640

Enrollment

Registered

2017-11-20

Start date

2018-04-23

Completion date

2021-12-02

Last updated

2025-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Subjects, Neurological Pathology

Keywords

PET imaging- Serotonin-Radiotracer

Brief 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.

Interventions

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Binding potentials	180 minutes	Binding potentials are calculated using compartimental modelling techniques.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026