A Phase 1, two-part study to evaluate prototype formulations of E5501

• Research type

  Research Study

• Full title

  A single-centre, randomised, open-label, two-part study to evaluate bioavailability of prototype third-generation formulations of E5501 relative to second-generation tablet formulation in healthy subjects

• IRAS ID

  94047

• Contact name

  Stuart Mair

• Sponsor organisation

  Eisai Inc

• Eudract number

  2011-005028-17

• Research summary

  The Sponsor is developing a new formulation of E5501. This study evaluates the amount of drug that is absorbed into the bloodstream when taken orally of three new prototype third generation formulations in comparison with an existing second generation formulation in healthy subjects.

• REC name

  HSC REC A

• REC reference

  11/NI/0169

• Date of REC Opinion

  30 Nov 2011

• REC opinion

  Further Information Favourable Opinion