A Pilot Study of a New Delivery Device and Solid Octreotide Implant

• Research type

  Research Study

• Full title

  A Pilot Two-Way Crossover Study To Investigate The Tolerability, Pharmacodynamics and Pharmacokinetics of A Solid Octreotide Implant Administered Subcutaneously Using The Glide Solid Dose Injector (GlideSDI®)

• IRAS ID

  42217

• Contact name

  Salvatore Febbraro

• Sponsor organisation

  Glide Pharmaceutical Technologies Ltd

• Eudract number

  2009-014915-11

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Octreotide is a synthetic (man-made) protein that's similar to a hormone in the body called somatostatin. It is usually given by injection and is licensed in the UK as Sandostatin injection. The sponsor (Glide Pharmaceutical Technologies Ltd) has developed a new needle-free method of delivering the drug via a device called the Glide Solid Dose Injector (Glide SDI©). The Glide SDI© device delivers a small (4 mm long and less that 1 mm wide), solid rod with a point at one end containing the drug through the skin. This may provide an alternative needle-free delivery system for this drug. This will be the first time that the Glide Octreotide implant has been tested in man. Sandostatin© will be used as the reference drug in the study. The sponsor, Glide Pharmaceutical Technologies Ltd, will provide the funding for this research.This is an open (both subjects and researchers will know which treatment is being received), randomised, phase 1, pilot (the first study of this kind to determine the best method of treatment), two-way, crossover study in a total of 18 healthy volunteers. The study is to assess the safety and pharmacokinetics of the drug (pharmacokinetics is the study of how the drug is handled by the body) after it has been administered using the new delivery device (GlideSDI©). Subjects will receive each of the following treatments once during the study (each separated by at least 7 days):Test: 100 micrograms (æg) octreotide implant using the Glide SDI©, administered under the skin of the abdomen. Reference: 100 æg Sandostatin© injection (1 ml), administered under the skin of the abdomen.

• REC name

  Wales REC 1

• REC reference

  09/WSE04/71

• Date of REC Opinion

  19 Jan 2010

• REC opinion

  Favourable Opinion