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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 May 2016
• Main ID: NCT02764892
• Date of registration: 25/09/2015
• Prospective Registration: No
• Primary sponsor: Vernalis (R&D) Ltd
• Public title: A Study in Healthy Male Volunteers to Investigate a New Drug for the Treatment of Parkinson's Disease
• Scientific title: An Open Label Study of V81444 Using Positron Emission Tomography to Assess Occupancy of Brain Adenosine A2A Receptors & Functional & Perfusion MRI to Explore Effects on Regional Brain Activity & Perfusion in Healthy Male Volunteers
• Date of first enrolment: August 2012
• Target sample size: 6
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02764892
• Study type: Interventional
• Study design: Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
• Phase: Phase 1

Key inclusion & exclusion 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



Age minimum: 25 Years
Age maximum: 55 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Parkinson's Disease

Intervention(s)

Drug: V81444

Primary Outcome(s)

Plasma concentration V81444 corresponding with 50% brain A2A receptor occupancy. [Time Frame: Up to 27 hours after a single dose]

Secondary Outcome(s)

Change versus placebo in proportion of subjects with adverse events [Time Frame: Up to 7 Days after last dose]

Change versus placebo in proportion of subjects with abnormal laboratory findings [Time Frame: Up to 7 Days after last dose]

Change versus placebo in proportion of subjects with clinically significant abnormalities in 12-lead ECG [Time Frame: Up to 7 Days after last dose]

Change versus placebo in proportion of subjects with clinically significant abnormalities on physical examination [Time Frame: Up to 7 Days after last dose]

Change versus placebo in proportion of subjects with clinically significant abnormalities on vital signs [Time Frame: Up to 7 Days after last dose]

Cognitive function using functional MRI [Time Frame: 5 hours after dosing]

Secondary ID(s)

V81444-1PD-02

Source(s) of Monetary Support

Please refer to primary and secondary sponsors