Photosensitising potential of JNJ-28431754

• Research type

  Research Study

• Full title

  A Randomized, Assessor- and Subject-Blind, Placebo- and Positive Controlled Study to Evaluate the Photosensitizing Potential of Multiple Oral Doses of JNJ 28431754 in Healthy Adult Men and Women

• IRAS ID

  20725

• Eudract number

  2009-011183-11

• Research summary

  This study involves a new investigational drug called JNJ-28431754. We are doing this study in order to test if this drug has potential to cause the skin to become more sensitive to light. Some drugs are unusual in that they make the skin more sensitive to sunlight. This results in the skin becoming slightly red and irritated. Laboratory tests suggest that JNJ 28431754 may cause skin sensitivity so this study is being conducted to assess whether this is the case.The Photobiology Unit (Spectratox) at Ninewells Hospital has developed an established method to test whether drugs cause increased sensitivity of skin as a result of taking a drug.The sensitivity of an individual??s skin to light is measured by shining small beams of light onto the back (about the area of a one penny piece each) and seeing how strong the light has to be before this patch of skin begins to redden. How long it takes for this redness to disappear is also measured. These results are compared with the results of tests carried out after the individual has been dosed with the drug that's being investigated.This study has been designed so that 48 volunteers are split into 4 groups of twelve. All volunteers will take study drug for 6 days. They will be allocated to treatment groups according to a randomisation code that's generated by a computer, which has no information about the individual - ie. by chance. The groups: Placebo (dummy drug): This is to see whether the results that are obtained are due to the drug or chance. Ciprofloxacin: This is a licensed drug, prescribed by doctors for bacterial infections, and is known to cause increased skin sensitivity. This is to check that the method of making the measurements is indeed working. JNJ-28431754: 100mg dose JNJ-28431754: 300mg dose

• REC name

  East of Scotland Research Ethics Service REC 1

• REC reference

  09/S1401/47

• Date of REC Opinion

  11 May 2009

• REC opinion

  Favourable Opinion