DS-5565: side effects & blood levels in healthy volunteers (ver A)

• Research type

  Research Study

• Full title

  A randomised, placebo-controlled, double-blind study of the safety, tolerability, pharmacokinetics and pharmacodynamics of single doses of DS-5565 in healthy Japanese, Korean, Chinese and Caucasian volunteers, and repeated doses of DS-5565 in Japanese volunteers

• IRAS ID

  68999

• Contact name

  Steve Warrington

• Sponsor organisation

  Daiichi Sankyo Development Ltd

• Eudract number

  2010-023567-18

• 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'll test single doses of DS-5565 in healthy Japanese, Korean, Chinese and Caucasian volunteers, and repeated doses of DS-5565 in healthy Japanese volunteers. We'll decide what doses to test after we??ve reviewed the results of a study in the USA. The highest dose we will give will be one that causes no important side effects in the USA study. Some particpants will take dummy medicine. We aim to find out the blood levels and side effects of DS-5565. In particular, study its effects on attention, coordination and balance, and find out whether it causes drowsiness or dizziness. also investigate whether the side effects differ among ethnic groups. 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 take up to 7 weeks to finish the study. They??ll make up to 2 outpatient visits, and stay on the ward for up to 16 nights. 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

  London - Brent Research Ethics Committee

• REC reference

  10/H0717/105

• Date of REC Opinion

  31 Jan 2011

• REC opinion

  Further Information Favourable Opinion