A safety, tolerability, PK and PD study of PHE377 in healthy males

• Research type

  Research Study

• Full title

  A Double-Blind, Randomised, Placebo-Controlled, Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PHE377, a TRPV1 Antagonist, in Healthy Male Subjects

• IRAS ID

  88789

• Contact name

  Stephen Evans

• Sponsor organisation

  PharmEste s.r.l.

• Eudract number

  2011-004243-53

• Research summary

  The new medicine tested in this study is a compound called PHE377. The compound is being developed for treating neuropathic pain. Neuropathic pain is a type of pain caused by a problem with one or more nerves in the body. There is often no ?injury?? or tissue damage that triggers the pain. However, the function of the nerve is affected in a way that it sends pain messages to the brain. Neuropathic pain is often described as burning, stabbing, shooting, aching, or like an electric shock.Neuropathic pain is less likely to be helped by traditional painkillers than nociceptive pain (pain caused by disease or injury outside the nervous system). However, other types of medicines often work well to ease the pain.The main purpose of the study is to see how safe the study drug is and how well it is tolerated after dosing. The study will also investigate how the study drug is taken up, metabolised (chemically broken down) and distributed through the body. The study will further investigate how the study drug affects the perception of painful stimuli.The study will be performed at the PAREXEL International Early Phase Clinical Unit in the UK (Harrow).A total of up to 36 participants will take part in the study. Additional subjects may be enrolled if replacements are required.Participants' blood and urine will be tested, and vital signs measurements and other medical tests will be performed. The effect of the study drug on the skin??s reaction to ultraviolet B (UVB) light, capsaicin and other sensory tests will be evaluated through tests measuring pain perception.

• REC name

  East of England - Cambridgeshire and Hertfordshire Research Ethics Committee

• REC reference

  11/IE/0150

• Date of REC Opinion

  20 Oct 2011

• REC opinion

  Further Information Favourable Opinion