[18F]-F13640 as a New Brain Radiopharmaceutical (F13640)

September 10, 2025 updated by: Hospices Civils de Lyon

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bron, France
        • Hospices Civils de Lyon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Input function group
Each subject underwent a 90 min acquisition PET scan with concomitant arterial blood sampling
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

Drug: [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
Experimental: Test-retest group
Each subject underwent 2 PET scans distant from 1 to 3 weeks
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

Drug: [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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Binding potentials
Time Frame: 180 minutes
Binding potentials are calculated using compartimental modelling techniques.
180 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Study Chair: Scheiber Christian, Hospices Civils de Lyon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 23, 2018

Primary Completion (Actual)

April 23, 2021

Study Completion (Actual)

December 2, 2021

Study Registration Dates

First Submitted

November 3, 2017

First Submitted That Met QC Criteria

November 17, 2017

First Posted (Actual)

November 20, 2017

Study Record Updates

Last Update Posted (Estimated)

September 12, 2025

Last Update Submitted That Met QC Criteria

September 10, 2025

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL16-0770
  • 2017-002722-21 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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