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

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ClinicalTrials.gov Identifier: NCT01634568
Recruitment Status : Completed
First Posted : July 6, 2012
Last Update Posted : July 10, 2012
Sponsor:
Information provided by (Responsible Party):
Vernalis (R&D) Ltd

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

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: V81444 Phase 1

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  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
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 Start Date : August 2011
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine


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





Primary Outcome Measures :
  1. Evaluate the safety of V81444 by assessing the frequency of adverse events [ Time Frame: From screening until 7 days post dosing ]
  2. 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 ]
  3. Evaluate the safety of V81444 by assessing ECG [ Time Frame: Taken at screening and until 7 days post dosing ]
  4. Evaluate the safety of V81444 by assessing vital signs [ Time Frame: Taken at screening and until 7 days post dosing ]
  5. Evaluate the safety of V81444 by assessing physical examination [ Time Frame: Taken at screening and post dosing ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01634568


Locations
United Kingdom
Hammersmith Medicines Research
London, United Kingdom, NW10 7EW
Sponsors and Collaborators
Vernalis (R&D) Ltd
Investigators
Principal Investigator: Steve Warrington Hammersmith Medicines Research

Responsible Party: Vernalis (R&D) Ltd
ClinicalTrials.gov Identifier: NCT01634568     History of Changes
Other Study ID Numbers: V81444-1PD-01
2011-001975-38 ( EudraCT Number )
First Posted: July 6, 2012    Key Record Dates
Last Update Posted: July 10, 2012
Last Verified: July 2012

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases