A study to investigate the PK of IV and Oral Microdoses of 4 compounds

• Research type

  Research Study

• Full title

  An exploratory, open label, randomized, parallel group study to investigate the pharmacokinetics of single intravenous and oral micro doses of PF-05186462, PF-05089771, PF-05241328 and PF-05150122 in healthy male subjects Quotient ref number: QCL-105590

• IRAS ID

  56791

• Contact name

  Stuart J Mair

• Sponsor organisation

  Pfizer, Ltd

• Eudract number

  2010-021126-35

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Chronic pain is a common problem affecting, approximately 1 in 5 adults across Europe. This disease has a large impact on the patient??s quality of life and although there are a variety of drugs available, many patients refrain from using these due to inadequate pain relief or intolerable side effects. Pfizer have identified this problem and intend to conduct this research to identify more effective therapies for chronic pain.The study drugs PF-05186462, PF-05089771, PF-05241328 and PF-05150122 are all highly potent inhibitors of human Nav 1.7. Human Nav 1.7 is present in pain sensing nerve fibres, where it is proposed to play a role in the perception and sensation of pain. The purpose of the study is to look at how PF-05186462, PF-05089771, PF-05241328 and PF-05150122 are taken up by the body when given by mouth and by injection.This is an open label single micro-dose study which will be administered to healthy male volunteers. There will be 8 groups each consisting of 5 volunteers who will be randomly allocated to receive one of the 4 study drugs (PF-05186462, PF-05089771, PF-05241328 and PF -05150122) and one of the treatment routes (oral or intravenous). There is no inactive drug (placebo) in this study. The results from each group will be compared with one another at the end of the study to see how the body treats the drugs differently and by the different treatment routes.

• REC name

  Scotland A REC

• REC reference

  10/IEC02/13

• Date of REC Opinion

  19 Jul 2010

• REC opinion

  Further Information Favourable Opinion