The boceprevir and sildenafil PK study

• Research type

  Research Study

• Full title

  A phase I study to assess the safety, tolerability and pharmacokinetic profile of boceprevir and sildenafil when dosed separately and together in healthy male volunteers.‘The boceprevir and sildenafil PK study’

• IRAS ID

  80390

• Contact name

  Alan Winston

• Sponsor organisation

  Imperial College London

• Eudract number

  2011-000680-27

• ISRCTN Number

  Unknown

• Research summary

  This is a healthy volunteer study looking at the interactions between two drugs: boceprevir and sildenafil. New drugs are being developed to treat people with the chronic viral infection hepatitis C. Very little is know how these new treatments interact with other medications such as the drugs used to treat erectile dysfunction. The purpose of this study is to look at levels of both a new hepatitis C drug called boceprevir (BOC) and an existing erectile dysfunction drug called sildenafil to see if they affect the blood levels of each other when given separately and together.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  11/LO/1385

• Date of REC Opinion

  30 Nov 2011

• REC opinion

  Further Information Favourable Opinion