GW824575 - first doses in humans, version1

• Research type

  Research Study

• Full title

  A single-centre, masked, placebo-controlled three part study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and repeat doses of the CC-chemokine receptor 3 (CCR3) antagonist, GW824575, in healthy male subjects or male asthmatics (11-021)

• IRAS ID

  95613

• Contact name

  Benjamin van hecke

• Sponsor organisation

  GlaxoSmithKline

• Eudract number

  2011-003287-70

• ISRCTN Number

  n/A

• Research summary

  GW824575 is an experimental new medicine that has never been given to humans before. It may be used to treat ??wet AMD??, an eye disease that leads to distorted vision or blindness. In wet AMD, new but fragile blood vessels grow in the back of the eye, and blood anflud can leak from them. We hope the study medicine will work by stopping the growth of those new blood vessels. GW824575 might also help in treating asthma. In asthma, the airways become inflamed (swollen and irritated) and that makes it difficult to breathe. We hope the study medicine will reduce the inflammation.We'll test single and repeated doses of GW824575 to see if it??s safe, and find out its side effects and blood levels.The study will be in 3 parts: Parts A and B in up to 28 healthy men; and Part C in 12 men with mild asthma.In Part A, We'll test single doses of GW824575 in 2 groups. Participants will have 4 study sessions (They'll stay on the ward for 3 nights in each session), and make 2 outpatient visits. They'll take about 9 weeks to finish the study.In Part B, We'll give participants repeated doses of GW824575 for 21 days. They'll stay on the ward for 23 nights, and make 3 outpatient visits. They'll take about 8 weeks to finish the study.In Part C, We'll give participants repeated doses of GW824575 for 14 days. They'll stay on the ward for 16 nights, and make 2 outpatient visits. They'll take about 7 weeks to finish the study. A pharmaceutical company (GlaxoSmithKline) is paying for the study.The study will take place at 1 centre in London. We'll recruit healthy participants by: advertising (newspaper, radio, and websites); word of mouth; volunteer databases; and our websites.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  11/LO/1968

• Date of REC Opinion

  20 Dec 2011

• REC opinion

  Favourable Opinion