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
Condition: Hepatitis C Virus
MeSH terms: Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the potential effect of TMC435 on the sensitivity of
      the skin towards exposure to sunlight. TMC435 is a drug that is currently under development
      for treatment of chronic hepatitis C virus infection. This study will be conducted in healthy
      volunteers. Ciprofloxacin, a commonly used antibiotic, is used as a positive control as this
      drug is known to mildly increase skin sensitivity to exposure to sunlight. This study also
      evaluates the levels of TMC435 and ciprofloxacin in the blood circulation and the safety and
      tolerability of TMC435.
    

Detailed description: 
      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.
    

Intervention name(s): TMC435; Placebo; Ciprofloxacin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): one morning TMC435 dose between 75 and 150 mg and a placebo dose at noon and in the evening, for 9 days; placebo dose in the morning, at noon and in the evening, for 9 days; one morning placebo dose and a noon and evening dose of ciprofloxacin 500 mg, for 9 days
Intervention MeSH terms: Ciprofloxacin; Simeprevir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Hepatitis C virus; TMC435-TiDP16-C125; TMC435-C125; TMC435; TMC435350; protease inhibitor; HCV; Hepatitis C; photosensitivity; phototoxicity