Phase I trial to assess photosensitising of TMC435 in healthy subjects
Research type
Research Study
Full title
A randomised, double-blind, double-dummy, placebo-and positive controlled Phase I trial to evaluate the photosensitising potential of TMC435 in healthy subjects.
IRAS ID
52517
Contact name
J. Brian Sanderson
Contact email
Sponsor organisation
Global Clinical Operations, a division of Janssen-Cilag Ltd (on behalf of Tibotec)
Eudract number
2010-019475-29
Research summary
This study is being conducted to assess the photosensitising potential of multiple oral doses of TMC435. TMC435 compared to placebo and Ciprofloxacin. Ciprofloxacin is a known mild photosensitiser and will be used in the study as a positive control.The study will consist of three phases: screening, treatment and follow-up. Screening will begin up to 21 days prior to the treatment phase. Subjects who meet initial screening criteria will proceed to baseline phototesting to assess the immediate photosensitivity response, this baseline testing will occur on 3 consecutive days during the screening period.After screening, subjects will be randomised to 1 of 3 treatment: TMC435 X mg once daily (Treatment A), ciprofloxacin 500 mgs twice daily (treatment B) or placebo (Treatment C). All treatments will be administered for 9 days. Blood sampling to determine the amount of drug in the subject's body will be carried out on days 8-10. Safety and tolerability will be continuously monitored throughout the trial.The study population will consist of 36 healthy volunteers aged between 18 and 55 years with skin types I, II and III. Subjects who develop an immediate photosensitivity response during the baseline assessment will not be enrolled. Subjects who prematurely discontinue study treatment will be replaced to ensure that 12 subjects in each treatment group will complete all required assessments up to and including Day 10 of the treatment phase.The study duration will be approximately 66 days in total: up to 21 days for screening phase, 11 days for treatment phase and the remainder for follow-up. Study duration may be longer for any subjects who require extended photosensitivity follow-up.
REC name
East of Scotland Research Ethics Service REC 1
REC reference
10/S1402/32
Date of REC Opinion
12 Jul 2010
REC opinion
Further Information Favourable Opinion