Safety & blood levels of GSK2339345 in a new inhaler; version 1

• Research type

  Research Study

• Full title

  A randomised, double-blind, placebo controlled, inhaled single escalating and repeat dose study using an aqueous droplet inhaler to investigate the safety, tolerability and pharmacokinetics of GSK2339345. HMR code 12-012.

• IRAS ID

  103052

• Contact name

  Elizabeth Tranter

• Sponsor organisation

  GlaxoSmithKline

• Eudract number

  2012-000127-40

• ISRCTN Number

  ISRCTN

• Research summary

  The study medicine is an experimental treatment for cough. Signals from nerves in the lining of the airways cause you to want to cough. When the lining of the airways becomes irritated, associated nerves may become sensitive, causing people who wouldn??t usually cough, to cough. We hope that the study medicine will work by blocking signals from nerves in the airway lining, and that it will be more effective and have fewer side effects than existing treatments. We will test single and repeated doses of the study medicine, when taken using a new inhaler. We aim to find out its side effects, blood levels, and whether it causes numbness in the mouth and throat, or has an unpleasant taste. No-one has taken the study medicine using the new inhaler before. Up to 26 healthy men, aged 18-65 years, will take part in the study. The first 8 participants (Group 1) will have 4 study sessions. In 3 sessions, they will inhale a single dose of study medicine and in 1 session, they will inhale placebo (dummy medicine). We will start with a low dose of study medicine, and increase the dose as they study progresses. Group 1 will take up to 8 weeks to finish the study, make 2 outpatient visits, and, in each session, stay on the ward for 2 nights. There will be 18 participants in Group 2. They will inhale 4 doses of study medicine or placebo daily for 2 days. They will take up to 5 weeks to finish the study, make 2 outpatient visits, and stay on the ward for 4 nights. A pharmaceutical company (GlaxoSmithKline, Brentford, UK) is funding the study. The study will take place at 1 centre in London. We will recruit healthy participants by word of mouth; volunteer databases and via our websites.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  12/LO/0400

• Date of REC Opinion

  4 Apr 2012

• REC opinion

  Favourable Opinion