First in Human Study of GSK2269557 in healthy males.

• Research type

  Research Study

• Full title

  A single-centre, double-blind, placebo-controlled three part study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single ascending and a repeat dose of nebulised GSK2269557 in healthy male subjects

• IRAS ID

  78761

• Sponsor organisation

  GSK

• Eudract number

  2010-024433-22

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  The drug being tested in this trial is GSK2269557. It is being developed as a possible treatment of diseases associated airway inflammation such as asthma.This will be the first time this drug has been given to man.The purpose of this study is to examine the safety and tolerability of single and multiple increasing inhaled doses of GSK2269557 in healthy male volunteers. The study will take place at Quintiles Drug Research Unit at Guy's Hospital.This study has 3 Parts (A, B and C). Up to 16 healthy male volunteers will participate in Part A of the study, 9 healthy male volunteers will participate in Part B and 24 healthy male volunteers will participate in Part C. In Part C healthy smokers will be evaluated to assess sputum anflud from the lungs. Each subject will participate in a screening period. In Part A there will be 4 treatment periods, each lasting for at least 4 days with an interval of 7 days between treatment periods. In Part B there will be a single treatment period lasting for at least 9 days. In Part C there will be up to 3 treatment periods, each lasting for at least 3 days and a study completion evaluation (between days 7-14 days after the last dose).The information gained in this study will help the sponsor of this study to determine whether GSK2269557 is suitable for further studies in humans.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  11/IE/0046

• Date of REC Opinion

  19 May 2011

• REC opinion

  Further Information Favourable Opinion