GSK573719 & GW642444: interaction with verapamil; version 1

• Research type

  Research Study

• Full title

  A single-centre, randomised, open-label study to evaluate the effects of steady-state verapamil, a moderate P-glycoprotein and CYP3A4 inhibitor, on the pharmacokinetics of GSK573719, and GSK573719 in combination with GW642444 (HMR code 09-018).

• IRAS ID

  44578

• Contact name

  Steve Warrington

• Sponsor organisation

  GlaxoSmithKline Research & Development

• Eudract number

  2010-018255-10

• ISRCTN Number

  N/A

• Research summary

  The study medicines (GSK573719 and GW642444) are experimental inhaled treatments for chronic obstructive pulmonary disease (COPD). People with COPD suffer from breathlessness because the small tubes (bronchioles) that carry air in and out of the lungs become narrow. Many people with COPD also take medicines, such as verapamil, for high blood pressure. So, we aim to find out if verapamil affects blood levels of the study medication. We'll give 32 healthy men and women, aged 18-65 years, 13 daily doses of the study medication and 5 daily doses of verapamil, a medicine used to treat high blood pressure. One group of participants will take GSK573719 alone, followed by GSK573719 with verapamil; and the other group of participants will take GSK573719 and GW642444 in combination, followed by that combination with verapamil. No-one will take dummy medicine. Participants will take about 7« weeks to finish the study. They??ll make up to 3 outpatient visits, and stay on the ward for 9 nights. 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 (newspaper, radio, and websites); by word of mouth; from volunteer databases; and via our websites.

• REC name

  Scotland A REC

• REC reference

  10/IEC02/1

• Date of REC Opinion

  15 Feb 2010

• REC opinion

  Further Information Favourable Opinion