Interaction of GSK2190915 with rosuvastatin; version 1

• Research type

  Research Study

• Full title

  An open label, sequential, single cohort, repeat dose study to investigate the potential interaction of GSK2190915 on the pharmacokinetics of rosuvastatin in healthy adult subjects (HMR code 10-013)

• IRAS ID

  60822

• Contact name

  Steve Warrington

• Eudract number

  2010-020853-14

• ISRCTN Number

  N/A

• Research summary

  GSK2190915 is an experimental new medicine for treating asthma and chronic obstructive pulmonary disease (COPD). People with those conditions get attacks of wheezing and breathlessness, caused by narrowing or inflammation of the small tubes (bronchioles) that carry air in and out of the lungs. We hope that GSK2190915 will work by blocking the production of substances in the body that are thought to narrow the bronchioles.People with asthma or COPD often need to take other medicines. Sometimes, when 2 medicines are taken together, the body takes longer to get rid of one (or both) of them. We??re doing this study to find out if taking GSK2190915 with rosuvastatin (a medicine used to treat high cholesterol) affects how the body handles rosuvastatin. No-one has taken GSK2190915 together with rosuvastatin before. So, we also aim to find out if the 2 medicines have any important extra side effects when taken together. 28 healthy men and women, aged 18??65 years, will take rosuvastatin once-daily for 7 days. Then, for the next 7 days, they??ll take rosuvastatin once-daily together with GSK2190915. No-one will take placebo.Participants will take up to 8 weeks to finish the study. They??ll stay on the ward for 5 days and nights, and have 12 outpatient visits. When they??re on the ward, We'll 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 healthy participants by: advertising (newspaper, radio, and websites); by word of mouth; from volunteer databases; and via our websites.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  10/H0717/64

• Date of REC Opinion

  8 Sep 2010

• REC opinion

  Favourable Opinion