Bioavailability of IDX719 in Healthy Subjects (QBR114833)

• Research type

  Research Study

• Full title

  A Phase I, single-dose, double-blind, placebo-controlled study to evaluate the relative bioavailability of IDX719 in healthy subjects.

• IRAS ID

  121311

• Contact name

  Sharan Sidhu

• Sponsor organisation

  Idenix Pharmaceuticals, Inc

• Eudract number

  2012-005311-69

• ISRCTN Number

  To be registered

• Research summary

  The Sponsor is developing the study drug, IDX719, for the potential treatment of Hepatitis C. There is a need for new antiviral drugs to treat Hepatitis C infection, which are more effective and better tolerated than currently available therapies. The purpose of the study is to assess how the study drug (IDX719) is taken up by the body and how this changes when given orally in up to 11 different forms. The study will hopefully identify the most appropriate form to take forward into further studies. Twenty subjects will be placed into 2 groups of 10 subjects. Subjects will be randomly assigned to receive single doses of 100mg IDX719 or placebo on 6 separate occasions. Each dose will be separated by a minimum 7 day wash out period.

• REC name

  Wales REC 2

• REC reference

  13/WA/0012

• Date of REC Opinion

  18 Jan 2013

• REC opinion

  Favourable Opinion