Neurological PathologyEarly Phase 1F13640NCT03347331
[18F]-F13640 as a New Brain Radiopharmaceutical
A Early Phase 1 study testing [18F]F13640 in people with Neurological Pathology and Healthy Subjects, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Neurological Pathology, Healthy Subjects
- What is being tested?
- [18F]F13640
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 23 Apr 2018to 2 Dec 2021
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Subjects
- Weight between 50 kg and 90 kg
- Affiliated to a social security or similar scheme
- Not subject to any legal protection measures
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Neurological Pathology, Healthy Subjects
- Being tested
- [18F]F13640
- Keywords
- PET imaging- Serotonin-Radiotracer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]F13640Drug
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]F13640Drug
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
| Study group | Role | What they receive |
|---|---|---|
| Input function group | Experimental | Each subject underwent a 90 min acquisition PET scan with concomitant arterial blood sampling Receives: Drug: [18F]F13640 |
| Test-retest group | Experimental | Each subject underwent 2 PET scans distant from 1 to 3 weeks Receives: Drug: [18F]F13640 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binding potentials
Binding potentials are calculated using compartimental modelling techniques.
Measured: 180 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2017
- Study start23 Apr 2018
- Primary completion23 Apr 2021
- Study completion2 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neurological PathologyStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Scheiber Christian, Study chair, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03347331
- Sponsor's protocol ID
- 69HCL16-0770
- Other IDs
- 2017-002722-21, 2017
- Acronym
- F13640
- Status last verified
- Apr 2022
- First submitted
- 3 Nov 2017
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Colom M, Costes N, Redoute J, Dailler F, Gobert F, Le Bars D, Billard T, Newman-Tancredi A, Zimmer L. 18F-F13640 PET imaging of functional receptors in humans. Eur J Nucl Med Mol Imaging. 2020 Jan;47(1):220-221. doi: 10.1007/s00259-019-04473-7. Epub 2019 Aug 14. No abstract available.
PubMed 31414208
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First-in-man Study of [18F]-F13640, a PET Radiopharmaceutical for Functional 5-HT1A Receptor Imaging
- ClinicalTrials.gov ID
- NCT03347331
- Acronym / sponsor ID
- F13640 / 69HCL16-0770
- Conditions
- Neurological Pathology, Healthy Subjects
- Keywords
- PET imaging- Serotonin-Radiotracer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 23 Apr 2018 (actual)
- Primary completion
- 23 Apr 2021 (actual)
- Study completion
- 2 Dec 2021 (actual)
- First posted
- 20 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Input function group | Experimental | Drug: [18F]F13640Each subject underwent a 90 min acquisition PET scan with concomitant arterial blood sampling |
| Test-retest group | Experimental | Drug: [18F]F13640Each subject underwent 2 PET scans distant from 1 to 3 weeks |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy Subjects
- Weight between 50 kg and 90 kg
- Affiliated to a social security or similar scheme
- Not subject to any legal protection measures
Key exclusion criteria (9 listed)
- Subjects with neurologic or psychiatric disease including all substance addictions
- Daily smokers
- Active infectious disease
- MRI contraindications
- PET contraindications determined with FDG injection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [18F]F13640Radiotracer 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 | Input function group |
| [18F]F136402 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 | Drug | Test-retest group |
Primary outcome
Binding potentials
Time frame: 180 minutes
Binding potentials are calculated using compartimental modelling techniques.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Results publication: PubMed 31414208Colom M, Costes N, Redoute J, Dailler F, Gobert F, Le Bars D, Billard T, Newman-Tancredi A, Zimmer L. 18F-F13640 PET imaging of functional receptors in humans. Eur J Nucl Med Mol Imaging. 2020 Jan;47(1):220-221. doi: 10.1007/s00259-019-04473-7. Epub 2019 Aug 14. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scheiber Christian study chair
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing [18F]F13640 in people with Neurological Pathology and Healthy Subjects, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Binding potentials (time frame: 180 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03347331, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.