A Study in Healthy Male Volunteers to Investigate a New Drug for the Treatment of Parkinson's Disease
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
1 other identifier
interventional
6
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Aug 2012
Shorter than P25 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
September 25, 2015
CompletedFirst Posted
Study publicly available on registry
May 6, 2016
CompletedMay 6, 2016
May 1, 2016
3 months
September 25, 2015
May 4, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Plasma concentration V81444 corresponding with 50% brain A2A receptor occupancy.
Plasma concentrations of V81444 and binding of \[11C\]SCH442416 radioligand to brain A2A receptors using PET before and after V81444 dosing to determine occupancy of A2A receptors by V81444.
Up to 27 hours after a single dose
Secondary Outcomes (6)
Cognitive function using functional MRI
5 hours after dosing
Change versus placebo in proportion of subjects with adverse events
Up to 7 Days after last dose
Change versus placebo in proportion of subjects with abnormal laboratory findings
Up to 7 Days after last dose
Change versus placebo in proportion of subjects with clinically significant abnormalities on vital signs
Up to 7 Days after last dose
Change versus placebo in proportion of subjects with clinically significant abnormalities in 12-lead ECG
Up to 7 Days after last dose
- +1 more secondary outcomes
Study Arms (1)
V81444
EXPERIMENTALSingle oral dose of V81444
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Any significant medical condition or a history of such a condition that the Investigator considers should exclude the subject from the study.
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 25, 2015
First Posted
May 6, 2016
Study Start
August 1, 2012
Primary Completion
November 1, 2012
Study Completion
March 1, 2013
Last Updated
May 6, 2016
Record last verified: 2016-05