CompletedPhase 1

[11C]Yohimbine PET Study of alpha2-AR

France16 participantsStarted 2018-05-21

Plain-language 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).

Who can participate

Age range

20 Years – 35 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Binding potentials

Timeframe: 180 minutes

Trial details

NCT IDNCT03520543

SponsorHospices Civils de Lyon

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-07-21

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