SB-705498 by nasal spray: safety and blood levels; v1

• Research type

  Research Study

• Full title

  A randomized, double-blind, placebo-controlled study in healthy volunteers to examine the safety, tolerability and pharmacokinetics of a) single, ascending and b) twice-daily repeat doses of intranasal SB-705498 (08-020)

• IRAS ID

  8901

• Contact name

  Steve Warrington

• Sponsor organisation

  GlaxoSmithKline Research & Development (R&D) Limited

• Eudract number

  2008-005174-12

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  The study medicine is an experimental treatment for rhinitis -- a condition where the inside of the nose becomes inflamed and swollen, leading to sneezing, itchin'ss, and a blocked or runny nose. We hope that the study medicine will reduce the sensitivity of the nerves in the nose to the thin's that trigger rhinitis. This will be the first time the study medicine has been taken by nasal spray and in repeated doses. We'll test single and repeated doses of the study medicine, to find out its side effects and blood levels. We'll also study how genes (pieces of DNA) affect the way the body responds to or handles the study medicine. The study is in 2 parts. Part 1: 14 healthy volunteers will take single, rising doses of study medicine. they'll have 5 study sessions, and stay on the ward for 2 nights in each session. they'll take about 8« weeks to complete Part 1. Part 2:2 groups of 15 new healthy volunteers will take twice-daily doses for 14 days. they'll stay on the ward for 7 nights, and make 1 outpatient visit. they'll take up to 7 weeks to complete Part 2. In each part of the study, We'll start with a low dose, and increase it as the study progresses. Some Participants will take a dummy medicine instead of the study medicine - neither they nor we will know which one they-re taking. Healthy volunteers can-t benefit from the study medicine, but they might benefit from ouriscreening tests, if we found an important problem. A pharmaceutical company, GlaxoSmithKline, is funding the study. The study will take place in Hammersmith medicines research (HMR) in London. We'll recruit Participants by: advertising (newspaper, radio, websites); word of mouth; from our volunteer databases; and via our website.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  08/H0717/71

• Date of REC Opinion

  3 Nov 2008

• REC opinion

  Favourable Opinion