A study in healthy males to investigate a new pain relief drug

• Research type

  Research Study

• Full title

  A Double-Blind, Randomised, Placebo-Controlled, Two-Part, Single Ascending Dose and Two-Way Crossover Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a TRPV1 Antagonist in Healthy Male Subjects

• IRAS ID

  70961

• Contact name

  Muna Albayaty

• Sponsor organisation

  PharmEste s.r.l.

• Eudract number

  2011-000305-47

• Research summary

  The new medicine tested in this study is a compound called PHE377. This compound is being developed for treating neuropathic pain (pain caused by damage to, or problems with nerve cells causing them to send pain messages to the brain). Neuropathic pain is a type of pain caused by a problem with one or more of the nerves themselves. 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 than nociceptive pain (pain caused by disease or injury outside the nervous system) to be helped by traditional painkillers. However, other types of medicines often work well to ease the pain. The main purpose of this 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, and how the study drug affects the skin??s reaction to ultraviolet B (UVB) light, capsaicin and other sensory tests. The study will be performed at the PAREXEL International Early Phase Clinical Unit in the UK (Harrow).Approximately 52 participants will be included in the study (approximately 32 in Part I and 20 in Part II). 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 (only for Part II of the study).

• REC name

  East of England - Cambridgeshire and Hertfordshire Research Ethics Committee

• REC reference

  11/IE/0026

• Date of REC Opinion

  15 Feb 2011

• REC opinion

  Favourable Opinion