Pharmacokinetics of a Unit-dose Device of Fentanyl Nasal Spray

• Research type

  Research Study

• Full title

  A Trial to Describe the Pharmacokinetics of a Unit dose Device of Fentanyl Nasal Spray in Healthy Subjects

• IRAS ID

  95909

• Contact name

  Simon Singer

• Sponsor organisation

  Archimedes Development limited

• Eudract number

  2011-005427-40

• ISRCTN Number

  95909/270770/1/158

• Research summary

  Archimedes Development Ltd, the sponsor of this study, has a licensed fentanyl product that is administered nasally (PecFent©) for the treatment of breakthrough pain of cancer (BTPc). BTPc is a pain that cancer patients suffer that ??breaks-through? their background pain medication which controls most of their pain. The current product is administered with a multi-dose device that is excellent for mobile patients with regular episodes of BTPc, but, not ideal for patients with less frequent episodes of BTPc. Accordingly, Archimedes has developed a unit-dose (single spray) device to benefit other patient groups. This study is designed to see how well fentanyl is delivered nasally to volunteers from a unit-dose device using a range of doses. The study will follow the concentrations of fentanyl in blood to estimate how quickly and how much drug is absorbed. The study will be conducted at a single site, a specialist Clinical Pharmacology Unit (CPU) where they are experienced in conducting studies of this sort. The volunteers will be required to visit the site on at least six occasions and the length of the trial for an individual subject will be about 12 weeks. The volunteers will be randomly assigned to four of eight treatments. At screening potential subjects will be judged as healthy (normal) before they can enrol in the study. There will be four treatment periods each with two overnight stays in the CPU when the volunteers will be dosed with fentanyl nasally and blood samples will be collected over 24 hours for the measurement of fentanyl concentrations. There will be a follow-up visit 7-14 days after the last dose.

• REC name

  East of England - Cambridgeshire and Hertfordshire Research Ethics Committee

• REC reference

  11/IE/0184

• Date of REC Opinion

  12 Jan 2012

• REC opinion

  Further Information Favourable Opinion