TMC435-TiDP16-C116 - Relative Bioavailability and Food Effect Study

• Absorption of TMC435 following administration of the HPMC capsule and of the gelatin capsule [ Time Frame: Over 72 hours for every treatment session ] [ Designated as safety issue: No ]
  
• Absorption of TMC435 following administration of the HPMC or gelatin capsule in the fed (following different meal types) and fasted state [ Time Frame: Over 72 hours for every treatment session ] [ Designated as safety issue: No ]
  

• Number of participants with adverse events and the severity of adverse events [ Time Frame: During maximum 7 weeks ] [ Designated as safety issue: Yes ]
  
• Percentage of abnormal values for laboratory parameters [ Time Frame: Up to maximum 7 weeks ] [ Designated as safety issue: Yes ]
  
• Observed values and changes from baseline of cardiovascular variables [ Time Frame: Up to maximum 7 weeks ] [ Designated as safety issue: Yes ]
  
• Evaluation of pulse and blood pressure values, based on changes from baseline and the percentage of participants with values beyond clinically important limits [ Time Frame: Up to maximum 7 weeks ] [ Designated as safety issue: Yes ]
  
• Physical examination findings and changes from baseline. [ Time Frame: Up to maximum 7 weeks ] [ Designated as safety issue: Yes ]
  

This is an open-label, randomized, single-dose, crossover trial in healthy volunteers. Crossover means that participants may receive different interventions sequentially during the trial. Randomized means that you will be assigned to a treatment sequence by chance, like flipping a coin. Open-label means that you and your physician will know what treatment you will receive. The study will consist of 3 phases: a screening phase, a treatment phase and a follow-up phase. Total study duration for an individual participant will be up to 6 or 7 weeks. Once found eligible after the screening phase, participants will take part in one of the two parts of the treatment phase. In the first part, a group of 24 participants will receive two treatment sessions, A and B. The order in which the treatments are given will be determined by chance. Treatment A is a single dose of TMC345 as one formulation (1 capsule). Treatment B is a single dose of TMC435 as another formulation (1 other type of capsule). Both treatments will be taken without food. In between the 2 sessions, there will be at least 7 days. In the second part, another group of 24 participants will receive 3 treatment sessions, C, D, and E. The order in which these treatments are given will be determined by chance. All 3 treatments will consist of a single dose of TMC435 as one of the 2 formulations given in the first part. In Treatment C this will be given without food, in Treatment D with a standardized breakfast and in Treatment E with a high-fat breakfast. In between the sessions, there will be at least 7 days. For all treatment sessions, participants will enter the study center the day before dosing and will remain there until the evening of the day after. The 3 following mornings, participants will come back to the study center. Five to 7 days after dosing, participants will have a last follow-up visit at the study center (follow-up phase). During the study, safety will be monitored, and during the treatment phase, at specified timepoints, blood samples will be taken for pharmacokinetic evalutions (effect of the body on the drug). In every treatment session, a single oral 150 mg TMC435 capsule will be given. One formulation will be a gelatin capsule. The other formulation will be a hydroxypropylmethylcellulose (HPMC) capsule.