The effect of GSK2190915 on the electrical function of the heart;ver 1

• Research type

  Research Study

• Full title

  A randomised, placebo controlled, four-way cross-over study to assess cardiac re-polarisation following repeat dosing with GSK2190915 and placebo for five days, with moxifloxacin as a positive control, in healthy male and female subjects (HMR code: 10-012)

• IRAS ID

  62235

• Contact name

  Steve Warrington

• Sponsor organisation

  GlaxoSmithKline Research & Development Ltd

• Eudract number

  2010-020120-21

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  GSK2190915 is an experimental new medicine for treating asthma and chronic obstructive pulmonary disease (COPD). People with asthma and COPD find it difficult to breathe, because the small tubes (bronchioles) that carry air in and out of the lungs become narrow. We hope that GSK2190915 will work by blocking the production of substances in the body that are thought to narrow bronchioles.We??re doing this study to find out if repeated doses of GSK2190915 have any important effects on the heart. We'll do that using electrocardiograms (ECGs), which painlessly record the electrical activity of the heart.To make sure that the study could detect any possible effects of GSK2190915 on ECGs, We'll also give volunteers a single dose of moxifloxacin ?? an antibiotic that causes small and short-lived changes in ECGs. Moxifloxacin is a marketed medicine.In this study, there??ll be up to 48 healthy men and women, aged 18 to 65 years. Participants will take up to 12 weeks to finish the study ?? they??ll spend 12 days and nights on the ward, and have 2 outpatient visits. Each participant will have 4 study sessions. In each session they??ll take 5 daily doses of GSK2190915 or placebo, and a single dose of moxifloxacin or placebo. Participants will take GSK2190915 and moxifloxacin as tablets. When the participants are on the ward, We'll do many ECGs, take blood samples, and do standard safety tests.A pharmaceutical company (GlaxoSmithKline) is funding the study.The study will take place at 1 centre in London. We'll recruit participants by: advertising (newspaper, radio, and websites); by word of mouth; from volunteer databases; and via our websites.

• REC name

  Scotland A REC

• REC reference

  10/IEC02/23

• Date of REC Opinion

  20 Sep 2010

• REC opinion

  Further Information Favourable Opinion