To investigate the safety,tolerability and Pharmacokinetics of AZD2516

• Research type

  Research Study

• Full title

  A Single Centre Two Part Randomized Phase I Study to Assess the Pharmacokinetics of an ER Formulation of AZD2516 and to Assess the Safety, Tolerability and Pharmacokinetics of AZD2516 after Multiple Ascending Doses in Healthy Volunteers

• IRAS ID

  52442

• Contact name

  Darren Wilbraham

• Sponsor organisation

  AstraZeneca

• Eudract number

  2008-006067-36

• Research summary

  AZD2516 is being developed for the oral treatment of chronic neuropathic pain. This study is split in to two parts. Part A will measure the effect of food and a new formulation of the drug in the blood and see how well it is tolerated. Part B will commence after the completion of Part A and will investigate the safety and tolerability of daily dosing with AZD2516. Part A of the study involves 6 visits over approximately 10 weeks. In total 16 volunteers will participate in Part A. Visits 2, 3, 4 and 5 involve a residential stay of 3 days each time on the unit. Part B of the study involves 3 visits over approximately 8 weeks. In total 62 volunteers will participate in Part B. The second visit involves a residential stay of 15 days in the unit.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  10/H0804/32

• Date of REC Opinion

  28 May 2010

• REC opinion

  Further Information Favourable Opinion