GSK2983559 First time in human study

• Research type

  Research Study

• Full title

  A single-centre, randomized, double-blind (sponsor open), placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of GSK2983559, in single (in both fed and fasted states) and repeat oral doses in healthy participants

• IRAS ID

  235974

• Contact name

  Michalis Kostapanos

• Contact email

  michalis.x.kostapanos@gsk.com

• Sponsor organisation

  GSK

• Eudract number

  2017-002664-40

• Duration of Study in the UK

  1 years, 1 months, 17 days

• Research summary

  This research study will investigate a new medicine, called GSK2983559 which is being developed for treatment of inflammatory diseases. GSK2983559 reduces the activation of the protein called Receptor Interacting Protein Kinase 2 (RIPK2), which is involved in the inflammatory response and (when over active) inflammatory diseases. It is hoped that by reducing the activation of RIPK2, the study medicine will prevent and treat a wide spectrum of inflammatory diseases.
  This is the first time that GSK2983559 study medicine will be given to humans. The primary aims of the study are to assess the safety, tolerability and blood levels of the drug when given in single and multiple doses. The study also includes measures in the blood of engagement of the drug with its target and investigates how the body deals with the drug.

  The study will be conducted in healthy volunteers in two parts. Part A comprises 2 groups, the first of 10 volunteers which will receive up to 5 increasing single doses of either GSK2983559 or Placebo each at 5 different periods. The second group of 8 volunteers will receive up to 4 increasing doses, and then will look at the effect of food by testing a previously tested dose with a high fat breakfast. In part B, four groups of 10 volunteers will receive repeated doses of either GSK2983559or Placebo for 14 days. Both parts will have a screening period of 28 days and a follow-up period 7-14 days after the last dose of GSK2983559 or Placebo.

  Taking part in the study will not have a direct benefit to volunteers. The study is sponsored by GSK, and will be conducted in a MHRA accredited GSK Clinical Unit in Cambridge UK, with adequate safety and compliance facilities.
  

• REC name

  Wales REC 2

• REC reference

  17/WA/0370

• Date of REC Opinion

  23 Nov 2017

• REC opinion

  Favourable Opinion