CompletedPhase 1

A Study in Healthy Male Volunteers to Investigate a New Drug for the Treatment of Parkinson's Disease

6 participantsStarted 2012-08

Plain-language summary

The main purpose of the study is to identify the best dose of V81444 to use in future trials in patients with Parkinson's disease. The study will also explore the effects of V81444 on brain activity and blood flow with tests of mental ability ("cognitive function tests"). It will also check how safe V81444 is and how well it is tolerated after dosing.

Who can participate

Age range

25 Years – 55 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: aged 25 to 55 years, in good general health as determined by medical history, physical examination and screening investigations, and taking no regular medication. * Confirmation to be sought for all volunteers that their general practitioner has provided an acceptable medical history. Exclusion Criteria: * Any significant medical condition or a history of such a condition that the Investigator considers should exclude the subject from the study. Specific exclusion criteria relate to * usual caffeine intake and willingness to abstain from caffeine * history or evidence of clinically significant gastro-intestinal disease * presence of structural brain abnormality * contraindications or cautions for MRI scanning * clotting test results * exposure to significant levels of ionising radiation in the past

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

Plasma concentration V81444 corresponding with 50% brain A2A receptor occupancy.

Timeframe: Up to 27 hours after a single dose

Trial details

NCT IDNCT02764892

SponsorVernalis (R&D) Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-11

View on ClinicalTrials.gov More Parkinson's Disease trials