TMC435-TiDP16-C116 - Relative Bioavailability and Food Effect Study
Condition: Hepatitis C
MeSH terms: Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare absorption of TMC435 formulated as 2 different types
      of capsules. After that, the absorption of one chosen TMC435 capsule will be compared when
      taken under fasting conditions or together with a standard or a high-fat meal. This will be
      done in healthy volunteers.
    

Detailed description: 
      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.
    

Intervention name(s): TMC435 HPMC capsule; TMC435 HPMC or gelatin capsule; TMC435 HPMC or gelatin capsule; TMC435 HPMC or gelatin capsule; TMC435 gelatin capsule
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Single intake of one 150-mg capsule without food; Single intake of one 150-mg capsule after high-fat breakfast; Single intake of one 150-mg capsule without food; Single intake of one 150-mg capsule after standardized breakfast; Single intake of one 150-mg capsule without food
Intervention MeSH terms: Simeprevir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: TMC435-TiDP16-C116; TMC435-C116; TMC435; HCV; Hepatitis C; Hep C; healthy volunteers