Comparing liquid and capsule forms of GSK2190915; version 1

• Research type

  Research Study

• Full title

  An open-label, randomised, single-dose, multi-cohort, crossover bioavailability study of a solution formulation and three capsule formulations of GSK2190915 in healthy adult subjects followed by a repeat-dose, randomized, parallel group, double-blinded study of one selected capsule formulation and matched placebo in elderly healthy subjects.

• IRAS ID

  18554

• Contact name

  Steve Warrington

• Sponsor organisation

  GlaxoSmithKline Research & Development Ltd

• Eudract number

  2009-010814-31

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  COPD is caused by narrowing of the small tubes (bronchioles) that carry air in and out of the lungs. Those affected get wheezing and breathlessness, persistent cough with phlegm, chest tightness, and tiredness. We hope that GSK2190915 will block the production of substances thought to cause narrowing of the bronchioles, and be a useful addition to COPD treatments.In this study, We'll compare 3 new capsule forms of GSK2190915 with a solution form. We'll test their safety, tolerability and blood levels. We'll also study how genes (pieces of DNA) affect the way the body responds to or handles the study medicine.Up to 47 healthy volunteers will take part in the study: 3 groups of young volunteers (Groups 1-3) and 1 group of 12 older volunteers (Group 4). In Groups 1-3, We'll test single doses of different forms of GSK2190915, and study the effect of food on the absorption of GSK2190915. Participants will take up to 9 weeks to finish the study, and have 4 study sessions. In each session, they??ll stay at the research unit for 2 nights and make 2 outpatient visits. In Group 4, We'll test 12 daily doses of GSK2190915. Participants will have 1 study session. They??ll stay at the research unit twice: once for 3 nights and once for 2 nights; and they??ll make 6 outpatient visits. Participants will take up to 8 weeks to finish the study.A pharmaceutical company, GlaxoSmithKline, is funding the study.The study will take place at 1 centre in London. We'll recruit healthy participants by: advertising (including newspaper, radio, websites); by word of mouth; and from our volunteer database.

• REC name

  Scotland A REC

• REC reference

  09/IEC02/5

• Date of REC Opinion

  20 Apr 2009

• REC opinion

  Favourable Opinion