New Formulation Study of GSK2269557 via Inhaler in Healthy Volunteers

• Research type

  Research Study

• Full title

  A randomised, double-blind, parallel group study to evaluate the safety, tolerability and pharmacokinetics of a single dose of GSK2269557 administered via the ELLIPTA™ dry powder inhaler to healthy participants

• IRAS ID

  225856

• Contact name

  Edward Banham-Hall

• Contact email

  edward.j.banham-hall@gsk.com

• Eudract number

  2017-001073-16

• Duration of Study in the UK

  0 years, 2 months, 24 days

• Research summary

  Glaxosmithkline (GSK) is developing a new medicine (GSK2269557) for the treatment of inflammatory airway diseases, such as chronic obstructive pulmonary disease (COPD) and asthma. Current treatment for these diseases focus only on relieving the symptoms. Phosphoinositide 3-kinase delta (PI3Kdelta) is a protein found mostly in some immune cells and plays an important role in promoting inflammatory reactions. GSK2269557 works by blocking this protein to help reduce the inflammatory reactions associated with these diseases.

  GSK2269557 has been studied in previous trials; however this study aims to test a new formulation of GSK2269557 that contains a reduction in the stabilizing agent magnesium stearate. Magnesium stearate has been reduced slightly from that studied in previous trials and it is anticipated this will increase the amount of study medicine that reaches the blood. In this study, GSK2269557 will be given via the ELLIPTA™ dry powder inhaler (DPI) and the main objective is to assess the blood levels of the new GSK2269557 drug powder. This study will be conducted in approximately 12 healthy male and female volunteers who will receive either:
  • GSK2269557 750 µg or
  • GSK2269557 500 µg

  Participants will receive the study medicine whilst being admitted at the study site. There will be outpatient visits on Days 3 and 6, and a follow-up telephone call by site personnel 10-12 days after their dose of study medicine. The total study duration for each participant is approximately 6 weeks.

  Taking part in the study will not have a direct benefit to participants. The study is sponsored by GSK, and will be conducted in a Medicines and Health care Products Regulatory Agency (MHRA) accredited clinical research unit in the United Kingdom, with adequate safety and compliance facilities.

• REC name

  Wales REC 1

• REC reference

  17/WA/0127

• Date of REC Opinion

  15 May 2017

• REC opinion

  Further Information Favourable Opinion