Single ascending doses of E-52862 in Caucasian volunteers

• Research type

  Research Study

• Full title

  A double-blind, randomised, placebo-controlled, 4-way cross-over Phase 1 study to investigate the pharmacokinetics, pharmacodynamics and safety of escalating single doses of E-52862 in young healthy male and female subjects

• IRAS ID

  54994

• Contact name

  Jorg Taubel

• Sponsor organisation

  Laboratorios del Dr Esteve S.A

• Eudract number

  2010-020343-13

• Research summary

  The main aim of the study is to compare the effect of a single dose of E-52862 to placebo on the changes in the ECG (electrocardiogram - electrical heart tracing) and on cognitive (information processing) function. In addition, the study will also evaluate the safety and tolerability of E-52862 and how much of E-52862 enters the blood. This study has been designed and sponsored by ESTEVE and will be conducted by Richmond Pharmacology Ltd (RPL). The study will involve up to 32 healthy male and female Caucasian volunteers aged 18-35 years inclusive, and will last approximately up to 9 weeks for each volunteer.E-52862 is an investigational medicinal product (IMP) that's being developed for the treatment of chronic pain, in particular neuropathic pain, as well as potentiating opioid analgesia in acute post-operative pain models. Its mode of action is by blocking s1 (sigma) receptors that act as amplifiers and are present in areas of pain control, such as the spinal cord and medulla. Similar to a lock-and-key model, the lock (receptor) fits in with the key (E-52862), and prevents other keys (other molecules) from activating the lock. As E-52862 has a different mode of action, it is expected to have an advantage over current treatment of chronic pain. E-52862 is not available by prescription or over the counter medication but is under research in clinical trials. It will be given to volunteers by mouth as a capsule.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  10/IEC07/9

• Date of REC Opinion

  21 Jun 2010

• REC opinion

  Further Information Favourable Opinion