QCL-104379 (PC C0104/09)

• Research type

  Research Study

• Full title

  An open label scintigraphic investigation to assess colonic delivery of HAL-HCl in healthy male subjects

• IRAS ID

  44250

• Contact name

  Philip Evans

• Sponsor organisation

  Photocure ASA

• Eudract number

  2009-017748-15

• Research summary

  The drug under investigation during this study is Hexylaminolevulinate HCl (HAL HCl) which is being developed to detect cancers of the large bowel (colon). The main purpose of this study is to investigate the distribution of radiolabelled HAL HCl when it is delivered directly to the end of the small intestine via the Enterion capsule. Initially an Enterion capsule containing an aqueous solution with no HAL HCl will be administered to confirm that spread in the colon is acheivable. Then an oily formulation of HAL Hcl will be delivered via the Enterion capsule to assess spread of the dose. Finally, a capsule designed to release the drug after it has left the stomach will also be radiolabelled and dosed to the volunteers to determine where in the intestine the drug is released. A Smart Pill will be dosed to certain groups of volunteers along with the aforementioned formulations to determine the acidity of the volunteers?? digestive system. All volunteers will be given Moviprep, a bowel cleansing preparation, prior to dosing as the dose is intended to be used to identify cancer in an empty bowel and to be assessed by colonoscopy. A radioactive drink will be given at the time of dosing to give an outline of the volunteers?? digestive system. It is planned that the first two volunteer groups will receive Enterion capsules containing an aqueous solution (Hexvix Solvent solution) that does not contain any HAL HCl. Group 3 will receive Enterion capsules containing the HAL HCl as an oily solution. Groups 4 and 5 will be dosed with the radiolabelled capsule containing HAL HCl and Smart Pill, and group 6 the capsule only. Each group of volunteers will receive only one dose.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  10/IEC01/1

• Date of REC Opinion

  24 Feb 2010

• REC opinion

  Further Information Favourable Opinion