A study of the effect of rifampicin on the drug levels of sotrastaurin

• Research type

  Research Study

• Full title

  An open-label, single-sequence, two-treatment, two-period study to assess the effect of Rifampicin on the pharmacokinetics of single-dose sotrastaurin in healthy subjects.

• IRAS ID

  84622

• Contact name

  Salvatore Febbraro

• Sponsor organisation

  Novartis Pharmaceuticals

• Eudract number

  2010-021989-30

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  The purpose of this study is to investigate the blood levels of a new drug called Sotrastaurin (AEB071), when taken with another commercially available dug called Rifampicin. Sotrastaurin is broken down in the body by an enzyme called CYP3A4. Rifampicin is known to increase the activity of the CYP3A4 enzyme in the body. Therefore, when these two drugs are taken together, the levels of sotrastaurin in the blood may be reduced because of the increased activity of the CYP3A4 (the enzyme will break down sotrastaurin faster). The information gained in this study will provide doctors guidance as to how much sotrastaurim to give to patients when combining sotrastaurin with medications that increase the activity of CYP3A4. Sotrastaurin has been already been tested in a number of healthy volunteers as well as patients with and has proved to be safe and well tolerated. Rifampicin is a type of antibiotic that's used in the treatment of different infections.This study will be conducted in 18 healthy male and female volunteers. During the study subjects will receive the following medication over 2 treatment periods:?½Day 1 of Period 1: A single 500mg oral dose of sotrastaurin?½Day 1 to 9 of period 2: A 600mg oral dose of Rifampicin, once daily.?½Day 10 of period 2: A single 500mg oral dose of sotrastaurin and a 600mg oral dose of Rifampicin.?½ Day 11 and 12 of period 2: A 600mg oral dose of Rifampicin, once daily

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  11/SC/0324

• Date of REC Opinion

  10 Oct 2011

• REC opinion

  Further Information Favourable Opinion