QBR110476

• Research type

  Research Study

• Full title

  A TWO-PART STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF AMORPHOUS/SOLID DISPERSION RIFAXIMIN

• IRAS ID

  73758

• Contact name

  Stuart J Mair

• Sponsor organisation

  Salix Pharmaceuticals, Inc.

• Eudract number

  2011-000185-36

• Research summary

  The study has been designed to look at the safety of rifaximin, how your body tolerates the drug and how the drug is taken up by your body when administered to different parts of your gut. Rifaximin is marketed in the USA as XIFAXAN©. This new formulation of rixaximin has not been dosed in humans before. Rifaximin is being developed for the treatment of IBS, traveller??s diarrhoea and hepatic encephalopathy. IBS (irritable bowel syndrome) is a common condition which intermittently affects bowel movements and can be uncomfortable in the gut region. Traveller??s diarrhoea is mild diarrhoea associated with changes in environmental conditions such as water. Hepatic encephalopathy is the occurrence of confusion, altered level of consciousness and coma as a result of liver failure and is caused by accumulation in the bloodstream of toxic substances that are normally removed by the liver. Part A will look at the safety of, and how the body tolerates and removes through the urine and faeces, different doses of rifaximin in 10 healthy subjects. The results from this part will the dose of study drug for Part B. Part B will look at how rifaximin is taken up by your body when administered to different parts of the gut in 12 healthy volunteers.

• REC name

  Scotland A REC

• REC reference

  11/IE/0032

• Date of REC Opinion

  30 Mar 2011

• REC opinion

  Further Information Favourable Opinion