Safety, tolerability, PK and PD of GSK1995057 in healthy subjects

• Research type

  Research Study

• Full title

  A two-part, randomised, placebo-controlled study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single doses of inhaled GSK1995057 in healthy subjects

• IRAS ID

  97444

• Contact name

  John Lambert

• Sponsor organisation

  GlaxoSmithKline Research & Development Limited

• Eudract number

  2011-005245-13

• ISRCTN Number

  xx

• Research summary

  The new medicine tested in this study is a compound called GSK1995057. This compound is being developed for treating acute lung conditions (ALC). ALC are serious illnesses that can have various causes. Lung disease can lead to severe respiratory problems, high blood pressure in the lung and heart failure. ALC must be identified as soon as possible and treated to prevent serious irreversible damage to the lungs. The main purpose of the study is to see how safe the study drug is and how well it is tolerated after dosing. The study will also investigate how the study drug is taken up, metabolised (chemically broken down), distributed through the body and excreted. A further aim is to look at how the body reacts toward the study drug. The study will be performed at the PAREXEL International Early Phase Clinical Unit in the UK (Harrow) And Celerion (Belfast).Approximately 71 participants will be included in the study (approximately 35 in Part 1 and 36 in Part 2). Additional subjects may be enrolled if replacements are required. Participants will undergo the following procedures during the study: medical history and demographic data will be collected, physical examinations and electrocardiograms (ECGs) will be performed, height and weight will be measured, blood pressure, pulse rate and body temperature measurements will be taken, different kinds of urine and blood safety tests will be performed, blood samples for measurement of the concentration of study drug, any adverse events that participants experience and other medication they take, will be recorded. Participants' air passages will be examined anflud inside their lungs will be collected for testing (Part 1, cohort 5 only and Part 2). In Part 2 participants' response to a inflammatory stimulus will also be examined.

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  12/LO/0134

• Date of REC Opinion

  19 Mar 2012

• REC opinion

  Further Information Favourable Opinion