A dose-escalation clinical trial with GSK2126458 in patients with IPF.

• Research type

  Research Study

• Full title

  A randomised, placebo-controlled, double-blind, repeat dose escalation study with GSK2126458 in patients with Idiopathic Pulmonary Fibrosis (IPF)

• IRAS ID

  111482

• Contact name

  Toby Maher

• Sponsor organisation

  GlaxoSmithKline

• Eudract number

  2012-001376-11

• ISRCTN Number

  n/a

• Research summary

  The purpose of this study is to test the levels, effects and safety of the study drug (GSK2126458) at different doses in patients with Idiopathic Pulmonary Fibrosis (IPF). IPF is a specific form of chronic, progressive fibrosing interstitial pneumonia of unknown cause, occurring primarily in older adults, and limited to the lungs. It is believed that GSK2126458 may stop the fibrotic process by damaging the abnormal cells that produce the fibres responsible for the disease. The study will compare GSK2126458 against placebo to see if the drug has any important side effects as well as assessing how the body handles the drug by measuring how much medicine gets into the blood and lungs. Furthermore, the study will measure changes in the levels of some biological substances found in blood and lunfluds that may help to determine how well the body responds to GSK2126458. Approximately 24 subjects will be involved in the study for between 7 and 8 weeks and will need to visit the study centre for 8 outpatient visits. At these visits they will need to have blood and urine samples taken and complete questionnaires. At two visits they will have a PET/CT scan, a well established procedure involving an injection of a radioactive glucose tracer known as FDG which is taken up by the cells in the body depending on how metabolically active they are, combining both functional imaging (PET) along with structural information (CT). In addition, subjects will have bronchoscopy/BAL at two visits where a bronchoscope (a flexible viewing tube) will be inserted through the mouth and down to the lungs and some salty water will be used tfluh out some of the cells in a small segment of the lungs. The study will be conducted in the UK and is funded by GlaxoSmithKline© (GSK©).

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  12/LO/1634

• Date of REC Opinion

  13 Nov 2012

• REC opinion

  Further Information Favourable Opinion