Blood levels and effects of GSK1325756; version 1

• Research type

  Research Study

• Full title

  A randomized cross-over study to evaluate the pharmacokinetics and pharmacodynamics of twice daily oral administration of GSK1325756, compared to placebo, in healthy fed subjects; and the pharmacokinetic profile of twice daily oral administration of GSK1325756 in healthy fed and fasted elderly subjects (HMR code 10-016).

• IRAS ID

  63695

• Contact name

  Steve Warrington

• Sponsor organisation

  GlaxoSmithKline

• Eudract number

  2010-022708-32

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  GSK1325756 is a new experimental medicine for treating chronic obstructive pulmonary disease (COPD). People with COPD suffer from breathlessness because the small tubes (bronchioles) that carry air in and out of the lungs become inflamed and narrow. The inflammation might be caused, or made worse, by having too many white blood cells, called neutrophils, in the lungs. GSK1325756 reduces the number of neutrophils in the lungs, and so reduces inflammation. We aim to test if GSK1325756 is safe and well tolerated when given twice-daily to middle-aged and elderly people. We'll also measure the amount of GSK1325756 in the blood, before and after a meal, and test its effects on neutrophils.The study will be done in 2 parts, A and B. There??ll be about 18 healthy men and women in each part. In part A they??ll be aged 40??64 years; in part B they??ll be 65??80 years. Part A comprises 3 treatment days and part B comprises 2 treatment days, at least 7 days apart. On Part A treatment days, participants will take 2 doses of 50 mg or 200 mg GSK1325756, or placebo (dummy medicine), 12 hours apart. They??ll each take all 3 treatments. They??ll stay in the research unit for a total of no more than 9 nights, completing the study in 8 weeks. Participants in part B will take 2 doses of 100 mg GSK1325756, 12 hours apart, before meals in one treatment period and after meals in the other. They??ll stay in the research unit for no more than 6 nights, completing the study in 7 weeks. This study will take place at a specialist research centre in London. We'll recruit participants by advertising (newspaper, radio, and websites), word of mouth, and from our volunteer database.GlaxoSmithKline is paying for the study.

• REC name

  Scotland A REC

• REC reference

  10/IEC02/26

• Date of REC Opinion

  27 Oct 2010

• REC opinion

  Further Information Favourable Opinion