The effect of food on blood levels of DS-5565; version 1

• Research type

  Research Study

• Full title

  A phase 1 open label, two-treatment incomplete three-way crossover single dose study to assess the effect of food on the pharmacokinetics of DS-5565 in healthy subjects. (HMR code: 11-004)

• IRAS ID

  75400

• Contact name

  Steve Warrington

• Sponsor organisation

  Daiichi Sankyo Development Ltd (DSD)

• Eudract number

  2011-000444-17

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  DS-5565 is an experimental treatment for neuropathic pain, which is pain caused by damage to the nerves. We hope that the study medicine will work by stopping nerves from sending unnecessary pain messages to the brain. We??re doing this study to find out if food affects the absorption of DS-5565 into the bloodstream. 22 healthy men and women (aged 18??45 years) will take 3 single 30 mg doses of DS-5565. If participants consent, take a blood sample that might be used to study how genes (pieces of DNA) affect the way the body responds to or handles DS-5565. Participants will have 3 study sessions. 11 participants will take DS-5565 after an overnight fast in 1 study session, and after a high-fat breakfast in 2 study sessions. The other 11 participants will take DS-5565 after an overnight fast in 2 study sessions, and after a high-fat breakfast in 1 study session. Participants will take up to 7 weeks to finish the study. They??ll stay on the ward for 3 days and nights in each study session, and make 2 outpatient visits. A pharmaceutical company (Daiichi Sankyo Development Ltd) is funding the study. The study will take place at 1 centre in London. We'll recruit healthy participants by: advertising (newspaper, radio, and websites); by word of mouth; from volunteer databases; and via our websites.

• REC name

  Scotland A REC

• REC reference

  11/IE/0030

• Date of REC Opinion

  21 Mar 2011

• REC opinion

  Further Information Favourable Opinion