Pilot Pharmacokinetic Investigation of Jext

• Research type

  Research Study

• Full title

  Pilot double-blind pharmacokinetic investigation of the absorption and bioavailability of adrenaline delivered from Jext®, EpiPen® and Anapen® in healthy adult volunteers

• IRAS ID

  68347

• Contact name

  Salvatore Febbraro

• Sponsor organisation

  ALK-Abello Ltd

• Eudract number

  2010-023937-44

• ISRCTN Number

  1

• Clinicaltrials.gov Identifier

  1

• Research summary

  The drug that is being tested in this study is Adrenaline (epinephrine).Adrenaline is a hormone that is naturally produced by the adrenal gland in the body. When it is produced in the body it stimulates the heart-rate, constricts blood vessels and dilates air passages, and has a number of more minor effects. Adrenaline is naturally produced in high-Stress or physically exhilarating situations. Adrenaline is the favoured treatment for anaphylactic shock (allergic reactions), and should be administered immediately if a person begins exhibiting severe allergic reactions. The main purpose of this study is to generate data to show how effective auto-injector delivery systems are, specifically the Jext device. Levels of adrenaline in the subject bloodstream will be measured when administered 300 mcg Jext compared to 300 mcg Anapen, 300 mcg Epipen, 500 mcg Anapen and placebo (saline). The sponsor, ALK-Abello Limited, will provide funding for this research. The study is a Phase 1 double-blind, placebo controlled, non-therapeutic clinical trial in healthy volunteers. A total of 12 subjects will be randomised to receive 5 treatments over 5 treatment periods. Subjects will be required to stay overnight on a total of 5 occasions. There will be at least 72 hours between administration of study drug. Blood samples will be collected for the measurement of adrenaline levels, as well as from safety screens. Other safety parameters will also be measured at pre-determined time-points during the study, these include blood Pressure, pulse and 12-lead digital Holter. Adverse events will be monitored throughout.

• REC name

  Wales REC 2

• REC reference

  10/WSE02/71

• Date of REC Opinion

  9 Dec 2010

• REC opinion

  Favourable Opinion