QCL-105484 (SB-683699)

• Research type

  Research Study

• Full title

  An open label, 4-way crossover study to evaluate the regional gastro-intestinal absorption, absolute bioavailability and metabolism of firategrast given as an oral dose and an intravenous microtracer dose of 14C-firategrast

• IRAS ID

  55128

• Contact name

  Joanne Collier

• Sponsor organisation

  GlaxoSmithKline Research and Development Ltd

• Eudract number

  2010-018393-20

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  This study aims to compare the bioavailability (the amount of drug present in the blood) of a single oral dose of firategrast, given in the form of both an immediate release tablet and a suspension of the drug (which means the drug is released in the stomach) compared with the drug being administered in a suspension within an Enterion capsule (meaning the drug will be released at specific sites in the small intestine and colon). In addition, half of the volunteers will also be dosed with the drug intravenously (directly into a vein) two hours after the single oral doses by tablet and suspension.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  10/IEC04/9

• Date of REC Opinion

  5 Jul 2010

• REC opinion

  Favourable Opinion