Study to investigate a new drug in healthy male subjects

• Research type

  Research Study

• Full title

  An open-label study of V81444 using positron emission tomography to assess occupancy of brain adenosine A2A receptors and functional and perfusion magnetic resonance imaging to explore effects on regional brain activity and perfusion in healthy male volunteers

• IRAS ID

  110190

• Contact name

  John Lambert

• Sponsor organisation

  Vernalis (R&D) Ltd (Vernalis)

• Eudract number

  2012-001025-27

• ISRCTN Number

  1

• Research summary

  The new medicine tested in this study is a compund called V81444 which is being developed for the treatment of Parkinson's disease (disorder of the nervous system) characterised clinically by three main symptoms: brady- or hypo-kinesia (slow and reduced range of movement), rigidity (resistance to movement of parts of the body), and resting tremor. The main purpose of the study is to identify the correct dose of V81444 in order for the drug to act at its most optimal. The study will also use techniques in order to explore the effects of V81444 on brain activity and the passage of flud through the vessels of the brain. A further aim of the study is to see how safe the study medication is and how well it is tolerated after dosing. Participants will receive one or two single oral doses with a washout period of 7 to 14 days. The first two subjects will each receive a single oral dose of V81444, 250 mg. Emerging receptor binding, pharmacokinetic, pharmacodynamic and safety information will be used to decide dose(s) for later subjects (maximum single dose, 250 mg). Participants will undergo the following procedures and assessments during the study: medical and medication history, including previous radiation exposure and piercing and tattoo information will be obtained; demographic data and information on smoking and alcohol intake will be recorded; physical examinations, including height, weight and Allen's tests, and vital signs (blood pressure, pulse rate and pulse oximetry) measurements and 12-lead ECGs will be performed. Participants will undergo PET and MRI scans and perform cognitive function tests; blood samples will be taken for safety laboratory tests, virology tests, genotyping, PK analysis of V81444 and PK analysis of radioligand. Urine samples will be collected for safety laboratory and drugs-of-abuse tests. Alcohol breathalyzer tests will be performed.

• REC name

  Wales REC 1

• REC reference

  12/WA/0204

• Date of REC Opinion

  26 Jul 2012

• REC opinion

  Further Information Favourable Opinion