[11C]Yohimbine PET Study of alpha2-AR

Phase 1

Completed

• Conditions: Healthy Controls
• Interventions: Drug: [11C]Yohimbine (Part B1) and [11C]Yohimbine + clonidine (Part B2); Drug: [11C]Yohimbine

• Registration Number: NCT03520543
• Lead Sponsor: Hospices Civils de Lyon

Brief 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 of \[11C\]Yohimbine uptake in the brain following single oral dose administration of clonidine (part B2).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-26
• Study First Submitted QC: 2018-05-08
• Study First Posted: 2018-05-09
• Study Start: 2018-05-21
• Primary Completion: 2018-07-21
• Study Completion: 2019-01-21
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-04
• Last Update Posted: 2020-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 16

Inclusion Criteria

• 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

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Exclusion Criteria

• 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
• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Part B : validity of the measure	[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
Part A : Imput function	[11C]Yohimbine	Compartmental model of the volume of distribution of \[11C\]Yohimbine in Brain by PET

Primary Outcome Measures

Name	Time	Method
Binding potentials	180 minutes	Binding potentials are calculated using compartmental modelling techniques

Secondary Outcome Measures

Name	Time	Method
Number of participants with adverse events as a measure of safety and tolerability	Up to 7 days after part B	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

Trial Locations

Locations (1)

Service de Neurologie C - Hôpital Neurologique et Neurochirurgical Pierre Wertheimer, GHE; 🇫🇷 Bron, France