A Clinical Trial to Find Out V81444's Side Effects and Blood Levels in Healthy Men

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

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 Overview

• Status: Completed
• Conditions: Parkinson's Disease
• Intervention / Treatment: Drug: V81444

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).

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, NW10 7EW
    • Hammersmith Medicines Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Ascending Dose; Single Ascending Doses of V81444 compared to placebo	Drug: V81444; Single ascending oral doses of V81444 and placebo Multiple ascending oral doses of V81444 and placebo
Experimental: Multiple Ascending Doses; Multiple ascending doses of V81444 compared to placebo	Drug: V81444; Single ascending oral doses of V81444 and placebo Multiple ascending oral doses of V81444 and placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evaluate the safety of V81444 by assessing the frequency of adverse events	From screening until 7 days post dosing
Evaluate the safety of V81444 by assessing laboratory safety assessments	Lab safety assessments are taken at screening, day minus 1, 24h and 72h and post dosing
Evaluate the safety of V81444 by assessing ECG	Taken at screening and until 7 days post dosing
Evaluate the safety of V81444 by assessing vital signs	Taken at screening and until 7 days post dosing
Evaluate the safety of V81444 by assessing physical examination	Taken at screening and post dosing

Collaborators and Investigators

• Sponsor: Vernalis (R&D) Ltd

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: June 20, 2012
• First Submitted That Met QC Criteria: July 2, 2012
• First Posted (Estimate): July 6, 2012

Study Record Updates

• Last Update Posted (Estimate): July 10, 2012
• Last Update Submitted That Met QC Criteria: July 9, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: V81444-1PD-01; 2011-001975-38 (EudraCT Number)