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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-000380-82 | EudraCT Number |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A : Imput function | Experimental | Compartmental model of the volume of distribution of [11C]Yohimbine in Brain by PET |
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| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [11C]Yohimbine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Binding potentials | Binding potentials are calculated using compartmental modelling techniques | 180 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to 7 days after part B |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chloe LAURENCIN, MD | Service de neurologie C | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de Neurologie C - Hôpital Neurologique et Neurochirurgical Pierre Wertheimer, GHE | Bron | 69500 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37238713 | Result | 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. |
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| ID | Term |
|---|---|
| D003000 | Clonidine |
| ID | Term |
|---|---|
| D048288 | Imidazolines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| [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). |
|
| D006571 |
| Heterocyclic Compounds |