Effect of rifampicin on blood levels of GRT6005; version 1

• Research type

  Research Study

• Full title

  A drug-drug-interaction trial to determine the effects of single- and multiple-dose administration of rifampicin on the pharmacokinetics of GRT6005 in healthy subjects (HMR code 11-012)

• IRAS ID

  85537

• Contact name

  Steve Warrington

• Sponsor organisation

  Grünenthal GmbH

• Eudract number

  2011-002771-41

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  The study medicine (GRT6005) is an experimental treatment for pain, similar to morphine. It works by stopping pain signals reaching the brain via the nerves. It also acts at sites in the brain where morphine has no effect.Patients on painkillers often need to take other medicines. Some medicines can make the body get rid of other medicines faster or more slowly: that can stop them working properly. We??re doing this study to find out if taking rifampicin (an antibiotic) with GRT6005 affects the elimination of GRT6005. We also aim to find out if the 2 medicines have any important extra side effects when taken together. No-one has taken GRT6005 together with rifampicin before. If participants consent, We'll also study how their genes (pieces of DNA) affect the way the body responds to or handles GRT6005. The study will be done in 40 healthy men and women aged 18??55 years. They??ll be in 2 groups.We'll test a single dose of GRT6005, taken alone and in combination with 11 daily doses of rifampicin in 32 participants. They??ll stay on the ward for 17 nights in total, and make 5 outpatient visits.We'll also test a single dose of GRT6005, taken alone and in combination with a single dose of rifampicin in 8 participants. They??ll stay on the ward for 10 nights in total, and make 5 outpatient visits.Participants will take up to 8 weeks to finish the study.A pharmaceutical company (GrǬnenthal GmbH) 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

  South Central - Berkshire B Research Ethics Committee

• REC reference

  11/IE/0089

• Date of REC Opinion

  10 Aug 2011

• REC opinion

  Further Information Favourable Opinion