Overview

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

Status:
Completed
Trial end date:
2013-03-01
Target enrollment:
0
Participant gender:
Male
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Vernalis (R&D) Ltd
Criteria
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