TMC435-TiDP16-C125 - Study in Healthy Volunteers to Evaluate the Potential of TMC435 to Increase the Sensitivity of the Skin Towards Exposure to Sun Light

• The effect of TMC435 versus placebo on the sensitivity of the skin towards sun light [ Time Frame: Final phototesting assessment will be done on day 9 and 10 during medication intake. ] [ Designated as safety issue: Yes ]
  

• Rate and extent of absorption of TMC435 and ciprofloxacin in the blood circulation [ Time Frame: Determined on Day1, 5, 6, 7, 8, 9 and 10, with extensive pharmacokinetic testing on Day7. ] [ Designated as safety issue: No ]
  
• Number of participants with Adverse Events as measures for Safety and Tolerability.. [ Time Frame: Until last follow-up visit 30-35 days after last drug intake. ] [ Designated as safety issue: No ]
  
• Number of Adverse Events (per type) as measures for Safety and Tolerability. [ Time Frame: Until last follow-up visit 30-35 days after last drug intake. ] [ Designated as safety issue: No ]
  
• Results of clinical laboratory evaluations as measures for Safety and Tolerability. [ Time Frame: Until last follow-up visit 30-35 days after last drug intake. ] [ Designated as safety issue: No ]
  
• Vital signs including ECG monitoring as measures for Safety and Tolerability. [ Time Frame: Until last follow-up visit 30-35 days after last drug intake. ] [ Designated as safety issue: No ]
  

This is a randomized (study drug assigned by chance), double blind (neither the study doctor, nor medical staff nor the healthy volunteer know the name of the assigned drug), double-dummy (all healthy volunteers take the same number of identically looking capsules, independent of the drug they have been assigned to), placebo- and positive-controlled (ciprofloxacin is a drug known to cause a mild photosensitive response) study. A total of 36 healthy volunteers will participate. Participants will be assigned to take TMC435 (one dose between 75 and 150 mg, once a day), TMC435-placebo (once a day) or ciprofloxacin (500 mg twice a day). The aim of this study is to look at the reaction of the skin after exposure to artificial sunlight when taking TMC435, ciprofloxacin or placebo. Study drug will be administered for 9 days. Phototesting (area of skin on your back will be exposed to artificial sunlight) will be conducted during 3 days before intake of study medication starts and during 3 days (Days 8, 9 and 10) during treatment. Skin reactions, general tolerability and safety of TMC435 will be assessed throughout the trial period (or longer if needed). Blood and urine samples will be taken at screening, on day 1, day 7, day 10 and at 2 follow-up visits. Blood levels of TMC435 and ciprofloxacin will be determined on Day 1, 5, 6, 7 (16 times), 8 (twice), 9 (twice) and 10. ECG and vital signs will be taken at screening, on day 1, twice on day 7, on day 10 and at 2 follow-up visits. A physical examination will be done at screening, on day 1, day 10 and at both follow-up visits. Volunteers assigned to the TMC435 group will receive a morning oral dose (dose between 75 and 150 mg) of TMC435 and a noon and evening oral dose of placebo, for 9 consecutive days. Volunteers assigned to the placebo group will receive oral placebo doses in the morning, at noon and in the evening, for 9 consecutive days. Volunteers assigned to the ciprofloxacin group will receive an oral morning placebo dose and a noon and evening oral dose of 500 mg ciprofloxacin, for 9 consecutive days.