QBR110919 (CX3115550)

• Research type

  Research Study

• Full title

  A Single Centre, 5-Period, Randomized Study to Evaluate the Relative Bioavailability of an Immediate Release Tablet Formulation and Prototype Bioenhanced Formulations of GSK1325756 in Healthy Elderly Subjects During Suppression of Gastric Acid Secretion

• IRAS ID

  88022

• Contact name

  Philip Evans

• Sponsor organisation

  GlaxoSmithKline Research & Development Limited

• Eudract number

  2011-002450-31

• Research summary

  The study will assess the combined effects of food and reduction of stomach acid on the take up of an existing tablet formulation and two new formulations of GSK1325756, which is being developed for the treatment of a chronic lung disease known as chronic obstructive pulmonary disorder, or COPD for short. The aim of the study is to understand if giving the drug with food improves take up of the drug into the body and reduces variability of take up between people given a second tablet to reduce the amount of stomach acid they produce. Another aim of the study is to assess whether two new formulations offer any improvement over the current tablet formulation when given with the second drug to reduce stomach acid.The study will be completed in a group of 20 healthy people aged 65-80 years. Study subjects will take a tablet to reduce stomach acid during each treatment period. In the first 4 treatment periods, study subjects will receive in a random order the current tablet formulation of GSK1325756 50 mg with and without food, and the two GSK1325756 50 mg new tablet formulations without food. Subjects will receive each of the formulations as a single dose by mouth. Blood samples will be collected at regular intervals to measure the amount of study drug taken up into the blood. The results of the 4 treatment periods will be reviewed to see if one of the new tablet formulations is better than the current tablet formulation. If one of the new formulations is better, then the study subjects will receive the selected new formulation with food during a fifth treatment period.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  11/IE/0133

• Date of REC Opinion

  27 Sep 2011

• REC opinion

  Further Information Favourable Opinion