Back to resultsA Clinical Trial to Find Out V81444's Side Effects and Blood Levels in Healthy Men
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
V81444
Sponsored by
About this trial
This is an interventional basic science trial for Parkinson's Disease
Eligibility Criteria
Inclusion Criteria:
- Healthy male volunteers: aged 18 to 45 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:
- have a history or evidence of clinically significant gastrointestinal disease, including ulcers, gastro-oesophageal reflux disease or gastritis
- any known malformations that would make OGD difficult or unsafe(Part B only)
- have taken V81444 in any previous investigational study
- have taken any restricted concomitant medication
- have multiple drug allergies or be allergic to any of the components of V81444 study medication or its matching placebo or midazolam (Part B only)
- in the 4 calendar months before study drug administration have smoked more than 5 cigarettes per day have consumed more than 28 units of alcohol per week have donated blood or plasma in excess of 500 mL been exposed to any new investigational agent or any other adenosine A2A receptor antagonist used non-steroidal anti-inflammatory drugs regularly had a new tattoo or body piercing
- have any clinically relevant abnormal findings at screening and/or admission
- intend to father a child with their female partner or through sperm donation within 4 months after the last dose of study medication
Sites / Locations
- Hammersmith Medicines Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Single Ascending Dose
Multiple Ascending Doses
Arm Description
Single Ascending Doses of V81444 compared to placebo
Multiple ascending doses of V81444 compared to placebo
Outcomes
Primary Outcome Measures
Evaluate the safety of V81444 by assessing the frequency of adverse events
Evaluate the safety of V81444 by assessing laboratory safety assessments
Evaluate the safety of V81444 by assessing ECG
Evaluate the safety of V81444 by assessing vital signs
Evaluate the safety of V81444 by assessing physical examination
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01634568
Brief Title
A Clinical Trial to Find Out V81444's Side Effects and Blood Levels in Healthy Men
Official Title
A Double-blind, Randomised, Placebo-controlled Study of the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Oral Doses of V81444 in Healthy Male Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vernalis (R&D) Ltd
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
A double-blind, randomised, placebo-controlled study of the safety, tolerability and pharmacokinetics of single and multiple ascending oral doses of V81444 in healthy male volunteers
Detailed Description
Part A - Single Ascending Dose (SAD) Double-blind, randomised, placebo-controlled, single ascending dose study.
Each study subject will participate in a screen visit, three identical treatment periods, in each of which they will receive a single oral dose of V81444 or placebo in accord-ance with the randomisation schedule, and one post-study visit.
In each treatment period, subjects will be admitted the day before dosing (Day -1) and, subject to satisfactory medical review, discharged in the morning, 4 days later (Day 4).
Part B - Multiple Ascending Dose (MAD) Double-blind, randomised, placebo-controlled, parallel group, multiple ascending dose study
Each study subject will participate in a screen visit, one treatment period in which they will receive repeated oral doses of V81444 or placebo in accordance with the randomisation schedule, and one post-study visit.
In each treatment period, subjects will be admitted the day before dosing (Day -1), dosed daily on Days 1 to 14 and, subject to satisfactory medical review, will be discharged in the morning, 3 days after the final dose (Day 17).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single Ascending Dose
Arm Type
Experimental
Arm Description
Single Ascending Doses of V81444 compared to placebo
Arm Title
Multiple Ascending Doses
Arm Type
Experimental
Arm Description
Multiple ascending doses of V81444 compared to placebo
Intervention Type
Drug
Intervention Name(s)
V81444
Intervention Description
Single ascending oral doses of V81444 and placebo
Multiple ascending oral doses of V81444 and placebo
Primary Outcome Measure Information:
Title
Evaluate the safety of V81444 by assessing the frequency of adverse events
Time Frame
From screening until 7 days post dosing
Title
Evaluate the safety of V81444 by assessing laboratory safety assessments
Time Frame
Lab safety assessments are taken at screening, day minus 1, 24h and 72h and post dosing
Title
Evaluate the safety of V81444 by assessing ECG
Time Frame
Taken at screening and until 7 days post dosing
Title
Evaluate the safety of V81444 by assessing vital signs
Time Frame
Taken at screening and until 7 days post dosing
Title
Evaluate the safety of V81444 by assessing physical examination
Time Frame
Taken at screening and post dosing
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy male volunteers: aged 18 to 45 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:
have a history or evidence of clinically significant gastrointestinal disease, including ulcers, gastro-oesophageal reflux disease or gastritis
any known malformations that would make OGD difficult or unsafe(Part B only)
have taken V81444 in any previous investigational study
have taken any restricted concomitant medication
have multiple drug allergies or be allergic to any of the components of V81444 study medication or its matching placebo or midazolam (Part B only)
in the 4 calendar months before study drug administration have smoked more than 5 cigarettes per day have consumed more than 28 units of alcohol per week have donated blood or plasma in excess of 500 mL been exposed to any new investigational agent or any other adenosine A2A receptor antagonist used non-steroidal anti-inflammatory drugs regularly had a new tattoo or body piercing
have any clinically relevant abnormal findings at screening and/or admission
intend to father a child with their female partner or through sperm donation within 4 months after the last dose of study medication
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steve Warrington
Organizational Affiliation
Hammersmith Medicines Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hammersmith Medicines Research
City
London
ZIP/Postal Code
NW10 7EW
Country
United Kingdom
12. IPD Sharing Statement
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A Clinical Trial to Find Out V81444's Side Effects and Blood Levels in Healthy Men
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