A Study to Determine the Relative Oral Bioavailability of Single Dose Administration of TMC207, Under Fed and Fasted Conditions in Healthy Participants
Condition: Healthy
MeSH terms: Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the relative oral bioavailability (the extent to
      which a medication or other substance becomes available to the body as compared with another
      form of medication or other substance) of TMC207 after single-dose oral administration of the
      Phase II clinical study tablet formulation, and a newly developed tablet formulations, under
      fed (with food) and fasted (without food) conditions.
    

Detailed description: 
      This is a 2-panel (2 groups), open-label (all people know the identity of the intervention),
      randomized (the study medication is assigned by chance), 3- way crossover (method used to
      switch participants from one treatment arm to another in a clinical study) study. The study
      consists of 3 phases including, the screening phase (less than or equal to 21 days before
      administration of study medication), treatment phase (84 days), and the follow-up phase (up
      to 30 to 35 days after the last blood sample in the last treatment session is collected).
      Approximately 24 healthy participants will be allocated to one of two panels: Panel A
      (participants will receive study medication under fed condition); and Panel B (participants
      will receive study medication under fasted condition). Participants in Panel A will be
      randomly assigned to 1 of 6 treatment sequences (Treatment sequences ABC, ACB, BAC, BCA, CBA,
      and CAB) to receive the following 3 formulations of TMC207 with food: Treatments A: the Phase
      II tablet formulation; Treatment B: newly developed tablet formulation with fine particle
      size distribution; and Treatment C: newly developed tablet formulation with coarse particle
      size distribution. Participants in Panel B will be randomly assigned to 1 of 6 treatment
      sequences (Treatment sequences DEF, DFE, EDF, EFD, FDE, and FED) to receive the following 3
      formulations of TMC207 without food: Treatments D: the Phase II tablet formulation; Treatment
      E: newly developed tablet formulation with fine particle size distribution; and Treatment F:
      newly developed tablet formulation with coarse particle size distribution. Subsequent
      treatments will be separated by a period of 4 weeks. The total duration of the study for each
      participant will be approximately 20 weeks. Safety evaluations will include assessment of
      adverse events, clinical laboratory tests, vital signs, electrocardiogram, physical
      examination, and alcohol urine medicine screen which will be monitored throughout the study.
    

Intervention name(s): Treatment A; Treatment B; Treatment C; Treatment D; Treatment E; Treatment F
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Participants will receive phase II clinical study tablet formulation of TMC207 100 mg as a single oral dose with food on Day 1, Day 30 and Day 58.; Participants will receive newly developed tablet formulation with fine particle size distribution of TMC207 100 mg as a single oral dose with food on Day 1, Day 30 and Day 58.; Participants will receive newly developed tablet formulation with coarse particle size distribution of TMC207 100 mg as a single oral dose with food on Day 1, Day 30 and Day 58.; Participants will receive phase II clinical study tablet formulation of TMC207 100 mg as a single oral dose without food on Day 1, Day 30 and Day 58.; Participants will receive newly developed tablet formulation with fine particle size distribution of TMC207 100 mg as a single oral dose without food on Day 1, Day 30 and Day 58.; Participants will receive newly developed tablet formulation with coarse particle size distribution of TMC207 100 mg as a single oral dose without food on Day 1, Day 30 and Day 58
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy; Bioavailability; Relative bioavailability; TMC207; Fed condition; Fasted condition