Boceprevir and St John’s Wort (SJW) interaction study

• Research type

  Research Study

• Full title

  SSAT 045: Phase I evaluation of the pharmacokinetics and safety of boceprevir and hypericin (St John's Wort) when co-administered to male and female healthy volunteers

• IRAS ID

  107088

• Contact name

  Marta Boffito

• Sponsor organisation

  Chelsea and Westminster NHS Foundation Trust

• Eudract number

  2012-001036-62

• ISRCTN Number

  xx

• Research summary

  The purpose of the study is to look at whether taking a new medication for hepatitis C (boceprevir), together with a herbal remedy commonly used for the treatment of depression (SJW), has any effect on the levels of boceprevir in the blood compared to when boceprevir is taken on its own. Treatment of hepatitis C genotype one, a specific common type of hepatitis C, has recently been revolutionised with the addition of a new class of drugs called protease inhibitors (PIs). Boceprevir belongs to this class of antiviral drugs and it is administered in combinations with other drugs to treat hepatitis C. One of the common side effects of treatment for hepatitis C is low mood (depression). SJW is known to cause drug interactions, so taking SJW at the same time as boceprevir may result in a change in how both of these drugs usually work. It is therefore important to find out if the levels of boceprevir in the blood are significantly affected by taking SJW. The study aims to help us understand whether it will be safe to take SJW whilst being simultaneously treated for hepatitis C with boceprevir.

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  12/LO/0833

• Date of REC Opinion

  22 Jun 2012

• REC opinion

  Favourable Opinion