Photosensitising potential of JNJ-28431754 in healthy subjects: 2part

• Research type

  Research Study

• Full title

  An Assessor-Blind, Two-Part Study to Investigate the Immediate Photosensitivity Response of Multiple Oral doses of JNJ-28431754 in Healthy Subjects

• IRAS ID

  22666

• Eudract number

  2009-012273-35

• Research summary

  This study involves an investigational drug called JNJ-28431754. Some drugs are unusual in that they make skin more sensitive to sunlight. This results in skin becoming slightly red and irritated. Laboratory tests suggest that JNJ-28431754 may cause skin sensitivity. 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 and seeing how strong the light has to be before this patch of skin begins to redden. How long it takes for 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 medicine that's being investigated.This study has been designed in two parts: Part 1: 10 volunteers who participated in JNJ-DIA-1011, and experienced a positive skin sensitivity reaction, will be reassessed to investigate whether their response was related to the study drug JNJ-28431754 or to the high intensity of light used. Volunteers will receive the same dose they received in DIA-1011, either 300mg once or 300mg twice daily for 5 or 6 days. Part 2: 36 volunteers may be enrolled to investigate if the skin response was related to the high intensity of light used in the DIA-1011 study or to the study medicine (JNJ-28431754). The number of subjects and doses of study medicine will be decided by the Sponsor and Study Doctor following a review of data from an ongoing study DIA-1019 part 1. Volunteers will receive either: 100mg once daily or 300mg once daily or 300mg twice daily for 5/6 days.

• REC name

  East of Scotland Research Ethics Service REC 1

• REC reference

  09/S1401/53

• Date of REC Opinion

  4 Jun 2009

• REC opinion

  Favourable Opinion