A Phase 0, Open-Label Microdose Study in Healthy Male Subjects

• Research type

  Research Study

• Full title

  A Phase 0, Two-Period, Randomised, Crossover, Open-Label Microdose Study to Compare Pharmacokinetics and Safety Following Single Oral Doses of SSP-1104R and Immediate Release Oxycodone in Healthy Male Subjects

• IRAS ID

  47126

• Contact name

  Joseph Chiesa

• Sponsor organisation

  Shire Pharmaceutical Development Ltd

• Eudract number

  2009-017243-34

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Shire is developing a new compound called SSP-1104R for use in the treatment of moderate to severe pain in adults. SSP-1104R biologically converts to the active form of a drug already on the market called Oxycodone. Oxycodone is an opioid (pain relieving agent) used in the treatment of moderate to severe pain in adults. Long term use of opioid drugs can cause drug tolerance and chemical dependency and in rare cases addiction as well. There is therefore an opening in the market for opioid compounds such as SSP-1104R that could potentially have lesser side effects than the current marketed compounds. This is the first time SSP-1104R will be tested in man. This study will take place in 2 treatment periods. It will be an open label study (the participants and Investigator staff will know which drug is being received) in which both study drugs (SSP-1104R as the test drug and Oxycodone Hydrochloride, HCl as the reference drug) will be given orally as a solution. The subjects will be 12 healthy adult males. Each subject will participate in two treatment periods. They will be randomly given either Oxycodone HCl or SSP-1104R in each treatment period. The subjects will stay in the research unit from before dose administration (Day -1) to Day 2 (24 hours post-dose) of each treatment period. There will be four days between each treatment period to allow the drug to wash out of the body. From screening to the last study visit it may take up to 7 weeks for the study to be completed.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  10/IEC05/2

• Date of REC Opinion

  25 Mar 2010

• REC opinion

  Further Information Favourable Opinion