TMC125IFD1001 - Drug-Drug Interaction of Etravirine With Telaprevir and TMC278 With Telaprevir.
Condition: Hepatitis C; HIV
MeSH terms: Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to see the effect of etravirine or TMC278 on how telaprevir is
      absorbed into the body and the effect of telaprevir on how etravirine or TMC278 are absorbed
      into the body when administered together.
    

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 approximately 11
      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 16 participants will
      receive two treatment sessions, A and B. The order in which the treatments are given will be
      determined by chance. In treatment A, 200 mg (2 tablets) ETR (etravirine) will be given twice
      a day from day 1 to 10 with a morning dose only on day 11. In treatment B, 750 mg (2 tablets)
      TVR (telaprevir) will be given from day 1 to 17 every 8 hours with a morning and afternoon
      dose only on day 18 and 200 mg ETR will be given twice a day from day 8 to 17 with a morning
      dose on day 18. In between the 2 sessions, there will be at least 14 days. In the second
      part, another group of 16 participants will receive 2 treatment sessions, C and D. The order
      in which these treatments are given will be determined by chance. In treatment C, 25 mg (1
      tablet) TMC278 will be given once a day from day 1 to 11. In treatment D, 750 mg (2 tablets)
      TVR (telaprevir) will be given from day 1 to 18 every 8 hours and 25 mg TMC278 will be given
      once a day from day 8 to 18. In between the 2 sessions, there will be at least 14 days. All
      treatments will be taken food. In treatments A and C, participants will come to the unit the
      day before dosing and in the mornings of day 1, 9 and 10 and for a whole day on day 11. Only
      in treatment C, overnight stay from day 11 to day 12 is foreseen. In treatment B,
      participants will come to the unit the day before dosing and in the mornings of days 1, 5, 6,
      8, 16 and 17 and for a whole day on days 7 and 18. In treatment D, participants will come to
      the unit the day before dosing and in the mornings of days 1, 5, 6, 8, 12, 16 and 17 and for
      a whole day on days 7 and 18 with overnight stay from day 18 to 19. Five to 7 days after last
      dosing, participants will have a last follow-up visit at the unit (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 drugs).
      In treatment A, 2 tablets ETR will be given twice a day from day 1 to 10 with a morning dose
      on day 11. In treatment B, 2 tablets TVR will be given every 8 hours from day 1 to17 with
      only 2 doses on day 18 and 2 tablets ETR twice a day from day 8 to 17 with a morning dose
      only on day 18. In treatment C, 1 tablet TMC278 will be given oncy a day from day 1 to 11. In
      treatment D, 2 tablets of TVR will be given every 8 hours from day 1 to 18 and 1 tablet
      TMC278 once a day from day 8 to 18.
    

Intervention name(s): ETR/telaprevir; TMC278/telaprevir; telaprevir/ETR; telaprevir/TMC278
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Treatment A: ETR 200 mg twice a day from Day 1 to Day 10 + a single dose in the morning on Day 11. Treatment B: telaprevir 750 mg every 8 hours from Day 1 to Day 17 + 2 doses (morning and afternoon) on Day 18, and ETR 200 mg twice a day from Day 8 to Day 17 + a single dose in the morning on Day 18.; Treatment C: TMC278 25 mg once day from Day 1 to Day 11. Treatment D: telaprevir 750 mg every 8 hours from Day 1 to Day 18, and TMC278 25 mg once daily from Day 8 to Day 18.; Treatment A: ETR 200 mg twice a day from Day 1 to Day 10 + a single dose in the morning on Day 11. Treatment B: telaprevir 750 mg every 8 hours from Day 1 to Day 17 + 2 doses (morning and afternoon) on Day 18, and ETR 200 mg twice a day from Day 8 to Day 17 + a single dose in the morning on Day 18.; Treatment C: TMC278 25 mg once day from Day 1 to Day 11. Treatment D: telaprevir 750 mg every 8 hours from Day 1 to Day 18, and TMC278 25 mg once daily from Day 8 to Day 18.
Intervention MeSH terms: Rilpivirine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis C; HIV; TMC125IFD1001; TMC125; Intelence; etravirine; ETR; TMC278; telaprevir; TVR; VX-950; healthy volunteers; crossover