A Pilot Study To Assess A New Solid Fentanyl Implant

• Research type

  Research Study

• Full title

  A Pilot Three-Way Crossover Study To Investigate The Tolerability and Pharmacokinetics of A New Solid Fentanyl Implant Administered Subcutaneously and Intramuscularly Using The Glide Solid Dose Injector™ (Glide SDI™)

• IRAS ID

  8452

• Sponsor organisation

  Glide Pharmaceutical Technologies Ltd

• Eudract number

  2008-002444-41

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Fentanyl is one of a group of medicines known as opioid analgesics which relieve or prevent pain. The marketed form of Fentanyl is usually given by injection with a needle into the muscle or by a patch applied to the skin. In the UK, the injectable form is called SublimazeTM. The sponsor (Glide Pharmaceutical Technologies Ltd) has developed a needle free drug delivery system called the Glide Solid Dose Injector?½ (Glide SDI?½). The Glide SDI?½ device delivers a small (4 mm long and less than 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 fentanyl implant has been tested in man. Sublimaze?½ will be used as the reference drug in the study. The sponsor, Glide, will provide the funding for this research. This is an open (both subjects and researchers will know which treatment is being received), randomised, phase I, pilot (the first study of this kind to determine the best method of treatment) study in a total of 18 healthy male 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). Subjects will receive each of the following treatments once during the study (each separated by at least 7 days): Test 1: 50 mcg Fentanyl implant using the Glide SDI?½, administered under the skin of the upper abdomen. Test 2: 50 mcg Fentanyl implant using the Glide SDI?½, administered into the muscle of the middle outer thigh Reference: 50 mcg Sublimaze injection, administered into the muscle of the upper outer thigh

• REC name

  London - Brent Research Ethics Committee

• REC reference

  08/H0717/65

• Date of REC Opinion

  11 Nov 2008

• REC opinion

  Further Information Favourable Opinion