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[11C]Yohimbine PET Study of alpha2-AR

NCT03520543 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2025-09-12

No results posted yet for this study

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).

Conditions

  • Healthy Controls

Interventions

DRUG

[11C]Yohimbine

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.

DRUG

[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).

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Principal Investigators

  • Chloe LAURENCIN, MD · Service de neurologie C

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
35 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-05-21
Primary Completion
2018-07-21
Completion
2019-01-21

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03520543 on ClinicalTrials.gov