TMC435-TiDP16-C119 - A Study Comparing 2 New Capsule Formulations of TMC435 to an Established Capsule Formulation and Evaluating the Respective Blood Levels of TMC435 Following Single Dose Administration

• Rate and extent of absorption of TMC435 following administration of 3 different capsule formulations under fed condition [ Time Frame: Measured over a period of 4 consecutive days (Day1-Day4) per treatment. Treatments (3) are 7 days apart from each other. During 1st day of each treatment, 10 blood samples for determination of pharmacokinetic characteristics are taken. ] [ Designated as safety issue: No ]
  

• All reported Adverse Events + percentage of subjects who experienced at least 1 occurrence of a given event as a measure of Safety and Tolerability following administration of single doses of 150 mg TMC435 [ Time Frame: Till last follow up safety visit 4-5 weeks after last intake of study medication ] [ Designated as safety issue: No ]
  

This is a randomized (study drug assigned by chance), open-label (all people involved know the treatment), single dose, crossover (volunteers will receive different treatments sequentially during the trial) study in healthy volunteers. The trial will evaluate the levels of TMC435 in the blood circulation after a single dose of 150 mg TMC435 administered as 3 different capsule formulations following breakfast. There will be a 7-day washout period between treatments and a 4-5 week follow-up at the end. Each volunteer will receive all three treatments. The main focus of the trial is the pharmacokinetic characteristics (how drugs are absorbed in the body, how they are distributed within the body and how they are removed from the body over time) of the different formulations. This evaluation requires multiple blood samples from Day 1 through 72 hours after dosing. Safety assessments (lab work, blood pressure, pulse and electrocardiogram) will follow a different schedule and are measured on Day -1 (day prior to taking first dose of drug), Day 1 (without lab work) and Day 4 of each treatment period, and 1 and 4-5 weeks after the last treatment. Each volunteer will receive 3 treatments, 7 days apart from each other. Each treatment consists of one single oral dose of 150 mg TMC435.