Investigation of controlled-release formulations MK-0518 (raltegravir)

• Research type

  Research Study

• Full title

  Pharmacoscintigraphic study to investigate the performance of novel controlled release (gastroretentive) formulations

• IRAS ID

  93383

• Contact name

  Philip Evans

• Sponsor organisation

  MSD Regional Business Support Centre GmbH

• Eudract number

  2011-005282-20

• Research summary

  The study drug (MK-0518) is one of a combination of drugs used in the treatment of HIV in adult patients It is currently given twice daily as a 400mg tablet for a daily dose of 800mg. This study is investigating how well the body absoris the drug when it is administered in three different formulations. These formulations are novel prototypes that are retained in the stomach for longer than normal and released slowly. It is hoped to facilitate development of a tablet formulation with a pharmacokinetic profile (how the drug is absorbed by the body) that allows once daily administration of MK-0518. Pharmacokinetic and scintigraphic data will be used to evaluate the drug release and absorption profile.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  11/IE/0182

• Date of REC Opinion

  6 Dec 2011

• REC opinion

  Further Information Favourable Opinion