Intravenous adenosine receptor modulator in healthy volunteers

• Research type

  Research Study

• Full title

  A single-centre, escalating dose study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of a slow intravenous infusion of GW328267X in healthy volunteers.

• IRAS ID

  88109

• Contact name

  Annelize Koch

• Sponsor organisation

  GlaxoSmithKline Research & Development Ltd

• Eudract number

  2011-001896-37

• Research summary

  The study drug, named GW328267X, has been tested in human'subjects for asthma and allergic rhinitis before as an inhaler through the mouth and nose in 10 studies, and in 1 study given into the veins. New studies in animals showed the study drug reduces the build up of fluid in the lungs when the lungs are damaged by lung infections or trauma and following organ transplants (acute lung injury). GW328267X previously caused increases in heart rate. The purpose of the presentresearch study is to see whether giving GW328267X very slowly into a vein over a period of 6 hours prevents the increase in heart rate. The results of this study will provide information to do further research to develop GW328267X as a potential treatment and prevention of acute lung injury. Following health screening for eligibility, 3 healthy male volunteers, aged 18-45 years, will receive GW328267X very slowly into a vein over a period of 6 hours (called intravenous infusion). The infusion will start with a low dose and increase to a slightly higher dose. The volunteers and the study staff will know which doses are given. The volunteers will be in bed. Their heart rate will be monitored continuously for 24h and their blood Pressure will be monitored frequently. The study will take place in a single research centre in the UK, which is hospital-based and has expertise in conducting studies with cardiac monitoring, and has adequate equipment and staff training to manage clinical emergencies. Antidote will be available. The intravenous infusion, or the study, will be stopped if pre-defined criteria in heart rate and blood Pressure changes are observed. If the intravenous infusion is well tolerated in the first 3 volunteers, 3 more volunteers will receive the intravenous infusion. The study is funded by GlaxoSmithKline (GSK).

• REC name

  East of England - Cambridgeshire and Hertfordshire Research Ethics Committee

• REC reference

  11/IE/0169

• Date of REC Opinion

  16 Nov 2011

• REC opinion

  Further Information Favourable Opinion