VX-950HEP1001 - Drug-drug Interaction Study Between Telaprevir and Raltegravir
Condition: Hepatitis C
MeSH terms: Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to confirm the absence of a clinically relevant interaction
      between telaprevir and raltegravir at steady-state.Telaprevir is being investigated for the
      treatment of chronic hepatitis C virus infection, and raltegravir is used to treat HIV
      infection.
    

Detailed description: 
      This is an open-label, randomized (the order in which you receive the treatment sessions is
      determined by chance, like tossing a coin), crossover (participants will receive different
      interventions sequentially during the trial) study in healthy participants to investigate the
      effect of telaprevir 750 mg, every 8 hours, on the pharmacokinetics (how the drug is absorbed
      into the bloodstream, distributed in the body and eliminated from the body) of raltegravir
      400 mg, twice a day, and vice versa. The study population will consist of 20 healthy
      participants. Each individual participant will receive two treatments: Treatment A
      (telaprevir 750 mg, every 8 hours, alone, on Days 1 to 6, with a morning dose on Day 7) and
      Treatment B (raltegravir 400 mg, twice a day, on Days 1 to 10 and telaprevir 750 mg, every 8
      hours, on Days 5 to 10, with a morning dose of raltegravir, and a morning and afternoon dose
      of telaprevir on Day 11). Half of the participants will receive first Treatment A and then
      Treatment B; the other half will receive first Treatment B and then Treatment A. There will
      be a washout period of at least 14 days between the 2 sessions. The screening period will be
      maximum 21 days; the treatment duration will be approximately 4.5 weeks, and the follow-up
      period will be 30 to 31 days. All study medication will be taken with food. On Day 7 of
      Treatment A and Day 11 of Treatment B, 9 blood samples will be taken for determination of the
      levels of telaprevir in the blood. On Days 4 and 11 of Treatment B, 10 blood samples will be
      taken for determination of the levels of raltegravir in the blood. Predose pharmacokinetic
      samples will be collected on other days during the treatment sessions. Safety and
      tolerability will be evaluated throughout the trial by evaluating results of blood and urine
      analyses, vital signs, physical examinations, electrocardiograms (electrical recording of the
      heart), drug and alcohol screenings, and by assessing how the participant is feeling. In
      Treatment A, participants will receive 2 oral tablets of telaprevir 375 mg every 8 hours on
      Days 1 to 6, with a morning dose on Day 7. In Treatment B, participants will receive 1 oral
      tablet of 400 mg raltegravir twice a day on Days 1 to 10 and 2 oral tablets of 375 mg
      telaprevir every 8 hours on Days 5 to 10, with a morning dose of raltegravir, and a morning
      and afternoon dose of telaprevir on Day 11.
    

Intervention name(s): Treatment sequence AB; Treatment sequence BA
Intervention type(s): Drug; Drug
Intervention description(s): Treatment A: telaprevir 750 mg every 8 hours on Days 1 to 6, with a morning dose on Day 7. Treatment B: raltegravir 400 mg twice a day on Days 1 to 10 and telaprevir 750 mg every 8 hours on Days 5 to 10, with a morning dose of raltegravir, and a morning and afternoon dose of telaprevir on Day 11.; Treatment A: telaprevir 750 mg every 8 hours on Days 1 to 6, with a morning dose on Day 7. Treatment B: raltegravir 400 mg twice a day on Days 1 to 10 and telaprevir 750 mg every 8 hours on Days 5 to 10, with a morning dose of raltegravir, and a morning and afternoon dose of telaprevir on Day 11.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: VX-950HEP1001; hepatitis; telaprevir; raltegravir; crossover; healthy volunteers; VX-950.