Healthy ControlsPhase 1[11C]YohimbineNCT03520543
[11C]Yohimbine PET Study of alpha2-AR
A Phase 1 study testing [11C]Yohimbine and [11C]Yohimbine (Part B1) and [11C]Yohimbine + clonidine (Part B2) in people with Healthy Controls, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The main purpose of this study is to model tissue specific kinetics of [11C]Yohimbine in healthy male participants by positron emission tomography (PET) and the appropriate arterial input function (part A) ; to determine the reproducibility of measures (classical test-retest study, part B1) and to measure the blocking… Read more about this study
- Who is it for?
- Ages 20 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Controls
- What is being tested?
- [11C]Yohimbine and [11C]Yohimbine (Part B1) and [11C]Yohimbine + clonidine (Part B2)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteFrance
- Study dates
- 21 May 2018to 21 Jan 2019
- Phase
- 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 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male volunteers
- Age between 20 years and 35 years
- Weight between 50kg and 90kg
- Without neurologic or psychiatric history
- Without head trauma history including loss of consciousness superior to 30 minutes.
- Affiliated to a social security or similar scheme
- Not subject to any legal protection measures
- Participant must have signed an informed consent document indicating that they understand the purpose of, and procedures required for, the study and are willing to participate in the study and comply with the study procedures and restrictions
Who cannot join
- Allen test (assessing the arterial blood flow to the hand) indicating abnormal blood supply to the hand
- Subject with orthostatic hypotension
- Subject with alcohol or substance abuses history
- Subject with somatic drug therapies
- MRI contraindications (implanted or embedded metal objects in the head or body)
- PET contraindications
Show all 9Show fewer
- Clonidine contraindications
- Exposed to 1 millisievert or more of ionizing radiation in the year before the start of this study
- Subject unable to sign written consent for participation in the study
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Neurologie C - Hôpital Neurologique et Neurochirurgical Pierre Wertheimer, GHE
Bron, 69500
About this study
Official title: Positron Emission Tomography Study of alpha2-adrenergic Receptors With [11C]Yohimbine
The main purpose of this study is to model tissue specific kinetics of [11C]Yohimbine in healthy male participants by positron emission tomography (PET) and the appropriate arterial input function (part A) ; to determine the reproducibility of measures (classical test-retest study, part B1) and to measure the blocking of [11C]Yohimbine uptake in the brain following single oral dose administration of clonidine (part B2).
- Conditions
- Healthy Controls
- Being tested
- [11C]Yohimbine, [11C]Yohimbine (Part B1) and [11C]Yohimbine + clonidine (Part B2)
- Keywords
- PET imaging, Noradrenaline, Radiotracer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[11C]YohimbineDrug
Each subject will receive an intravenous (IV) bolus injection of [11C]Yohimbine at a dose of 370 MegaBecquerel (MBq) ± 10% with concomitant arterial blood sampling. The distribution of [11C]Yohimbine in brain will be measured by dynamic PET scans obtained from the time of injection for up to 90 minutes along with measurement of the tracer input function with arterial samples for intact tracer and metabolites to establish the total and regional compartmental kinetics of [11C]Yohimbine.
[11C]Yohimbine (Part B1) and [11C]Yohimbine + clonidine (Part B2)Drug
Part B1 : Test Retest Variability will be assessed on percent difference in the binding potential following [11C]Yohimbine PET scan (IV bolus injection of [11C]Yohimbine at a dose of 370 MBq ± 10%) obtained at least 1 week after [11C]Yohimbine PET scan of part A.
Part B2 : Occupancy of alpha2-adrenergic receptors in brain by clonidine will be evaluated by comparing the binding potential of [11C]Yohimbine (IV bolus injection of [11C]Yohimbine at a dose of 370 MBq ± 10%) after single oral dose of clonidine (0,15mg) to the binding potential of [11C]Yohimbine obtained at baseline (part A).
| Study group | Role | What they receive |
|---|---|---|
| Part A : Imput function | Experimental | Compartmental model of the volume of distribution of [11C]Yohimbine in Brain by PET Receives: Drug: [11C]Yohimbine |
| Part B : validity of the measure | Experimental | Part B1 : Test Retest Variability in the distribution of [11C]Yohimbine Part B2 : Percentage of alpha2-adrenergic receptor occupancy Receives: Drug: [11C]Yohimbine (Part B1) and [11C]Yohimbine + clonidine (Part B2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binding potentials
Binding potentials are calculated using compartmental modelling techniques
Measured: 180 minutes
Secondary outcomes (1)
Number of participants with adverse events as a measure of safety and tolerability
An adverse effect is any untoward medical events that occur in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product
Measured: Up to 7 days after part B
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2018
- Study start21 May 2018
- Primary completion21 Jul 2018
- Study completion21 Jan 2019
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 Healthy ControlsStudies 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
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chloe LAURENCIN, MD, Principal investigator, Service de neurologie C
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03520543
- Sponsor's protocol ID
- 69HCL17_0196
- Other IDs
- 2018-000380-82, 2018
- Acronym
- [11C]Yohimbine
- Status last verified
- Feb 2020
- First submitted
- 26 Apr 2018
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Laurencin C, Lancelot S, Merida I, Costes N, Redoute J, Le Bars D, Boulinguez P, Ballanger B. Distribution of alpha2-Adrenergic Receptors in the Living Human Brain Using [11C]yohimbine PET. Biomolecules. 2023 May 15;13(5):843. doi: 10.3390/biom13050843.
PubMed 37238713
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
- Positron Emission Tomography Study of alpha2-adrenergic Receptors With [11C]Yohimbine
- ClinicalTrials.gov ID
- NCT03520543
- Acronym / sponsor ID
- [11C]Yohimbine / 69HCL17_0196
- Conditions
- Healthy Controls
- Keywords
- PET imaging, Noradrenaline, Radiotracer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 21 May 2018 (actual)
- Primary completion
- 21 Jul 2018 (actual)
- Study completion
- 21 Jan 2019 (actual)
- First posted
- 9 May 2018 (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.
The main purpose of this study is to model tissue specific kinetics of [11C]Yohimbine in healthy male participants by positron emission tomography (PET) and the appropriate arterial input function (part A) ; to determine the reproducibility of measures (classical test-retest study, part B1) and to measure the blocking of [11C]Yohimbine uptake in the brain following single oral dose administration of clonidine (part B2).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A : Imput function | Experimental | Drug: [11C]YohimbineCompartmental model of the volume of distribution of [11C]Yohimbine in Brain by PET |
| Part B : validity of the measure | Experimental | Drug: [11C]Yohimbine (Part B1) and [11C]Yohimbine + clonidine (Part B2)Part B1 : Test Retest Variability in the distribution of [11C]Yohimbine Part B2 : Percentage of alpha2-adrenergic receptor occupancy |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy male volunteers
- Age between 20 years and 35 years
- Weight between 50kg and 90kg
- Without neurologic or psychiatric history
- Without head trauma history including loss of consciousness superior to 30 minutes.
Key exclusion criteria (9 listed)
- Allen test (assessing the arterial blood flow to the hand) indicating abnormal blood supply to the hand
- Subject with orthostatic hypotension
- Subject with alcohol or substance abuses history
- Subject with somatic drug therapies
- MRI contraindications (implanted or embedded metal objects in the head or body)
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 |
|---|---|---|
| [11C]YohimbineEach subject will receive an intravenous (IV) bolus injection of [11C]Yohimbine at a dose of 370 MegaBecquerel (MBq) ± 10% with concomitant arterial blood sampling. The distribution of [11C]Yohimbine in brain will be measured by dynamic PET scans obtained from the time of injection for up to 90 minutes along with measurement of the tracer input function with arterial samples for intact tracer and metabolites to establish the total and regional compartmental kinetics of [11C]Yohimbine. | Drug | Part A : Imput function |
| [11C]Yohimbine (Part B1) and [11C]Yohimbine + clonidine (Part B2)Part B1 : Test Retest Variability will be assessed on percent difference in the binding potential following [11C]Yohimbine PET scan (IV bolus injection of [11C]Yohimbine at a dose of 370 MBq ± 10%) obtained at least 1 week after [11C]Yohimbine PET scan of part A. Part B2 : Occupancy of alpha2-adrenergic receptors in brain by clonidine will be evaluated by comparing the binding potential of [11C]Yohimbine (IV bolus injection of [11C]Yohimbine at a dose of 370 MBq ± 10%) after single oral dose of clonidine (0,15mg) to the binding potential of [11C]Yohimbine obtained at baseline (part A). | Drug | Part B : validity of the measure |
Primary outcome
Binding potentials
Time frame: 180 minutes
Binding potentials are calculated using compartmental modelling techniques
1 secondary outcome
Number of participants with adverse events as a measure of safety and tolerability
Time frame: Up to 7 days after part B
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 37238713Laurencin C, Lancelot S, Merida I, Costes N, Redoute J, Le Bars D, Boulinguez P, Ballanger B. Distribution of alpha2-Adrenergic Receptors in the Living Human Brain Using [11C]yohimbine PET. Biomolecules. 2023 May 15;13(5):843. doi: 10.3390/biom13050843.
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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.
Chloe LAURENCIN, MD principal investigator
Service de neurologie C
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [11C]Yohimbine and [11C]Yohimbine (Part B1) and [11C]Yohimbine + clonidine (Part B2) in people with Healthy Controls, 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 8 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 NCT03520543, 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.