VX-950-TiDP24-C124: A Phase I Trial to Investigate the Potential Pharmacokinetic Interactions Between Telaprevir and Darunavir/Ritonavir and Between Telaprevir and Fosamprenavir/Ritonavir at Steady-state.
Condition: Hepatitis C; Telaprevir; HIV
MeSH terms: Hepatitis C
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objectives are to determine the effect of steady-state DRV/rtv 600/100 mg twice
      daily (b.i.d.) on the steady-state pharmacokinetics of telaprevir 750 mg every (q) 8h and
      1125 mg q12h and vice versa;- to determine the effect at steady-state of fAPV/rtv 700/100 mg
      b.i.d. on the steady-state pharmacokinetics of telaprevir 750 mg q8h and 1125 mg q 12h and
      vice versa; to determine the steady-state pharmacokinetics of telaprevir 750 mg q8h versus
      telaprevir 1125 mg q12h, alone and during coadministration of either steady-state DRV/rtv
      600/100 mg b.i.d or fAPV/rtv 700/100 mg b.i.d.
    

Detailed description: 
      This is a Phase I, open-label, randomized (patients are assigned different treatments based
      on chance), 2-way crossover trial in 2 panels of healthy subjects to investigate the effect
      of steady-state darunavir/ritonavir (DRV/rtv) 600/100 mg b.i.d. (twice a day) or
      fosamprenavir/ritonavir (fAPV/rtv) 700/100 mg b.i.d. on the steady state pharmacokinetics
      (study of the bodily absorption, distribution, metabolism, and excretion of drugs) of
      telaprevir 750 mg q 8h and 1125 mg q12h, and vice versa.Telaprevir is being investigated for
      the treatment of HCV infection.The trial will enroll 40 subjects, divided over 2 panels of 20
      subjects each. Subjects in Panel 1 will receive Treatments A and B, and subjects in Panel 2
      will receive Treatments C and D, in a randomized order. In both panels, treatments will be
      separated by a washout period of at least 13 days. In Panel 1, Treatment A, subjects will
      receive telaprevir 750 mg q8h on Days 1 to 10, and telaprevir 1125 mg q12h on Days 11 to 13
      with a morning dose on Day 14. In Panel 1, Treatment B, subjects will receive DRV/rtv 600/100
      mg b.i.d. on Days 1 to 23, with an additional morning dose on Day 24, with coadministration
      of telaprevir 750 mg q8h on Days 11 to 20, and 1125 mg q12h on Days 21 to 23 with a morning
      dose on Day 24. In Panel 2, Treatment C, subjects will receive telaprevir 750 mg q 8h on Days
      1 to 10, and telaprevir 1125 mg q12h on Days 11 to 13 with a morning dose on Day 14. In Panel
      2, Treatment D, subjects will receive fAPV/rtv 700/100 mg b.i.d. on Days 1 to 23, with an
      additional morning dose on Day 24, with coadministration of telaprevir 750 mg q8h on Days 11
      to 20, and 1125 mg q12h on Days 21 to 23 with a morning dose on Day 24. All intakes of study
      medication will be under fed conditions. Pharmacokinetic profiles of telaprevir and
      VRT-127394 (Rdiastereomer of telaprevir) will be measured up to 8 hours after intake of the
      morning dose on Day 10 of Treatments A and C and on Day 20 of Treatments B and D, and up to
      12 hours after intake of the morning dose of Day 14 of Treatments A and C and on Day 24 of
      Treatments B and D. During Treatment B, pharmacokinetic profiles of DRV and ritonavir will be
      measured up to 12 hours after intake of the morning dose on Day 10, Day 20 and Day 24. During
      Treatment D, pharmacokinetic profiles of amprenavir and ritonavir will be measured up to 12
      hours after intake of the morning dose on Day 10, Day 20 and Day 24. Safety and tolerability
      evaluations will be recorded at regular intervals throughout the trial period. Group A/C:
      telaprevir 750 mg each 8 hrs on Days 1-10, and telaprevir 1125 mg each 12hrs on Days 11-13
      with a morning dose on Day 14. Group B: DRV/rtv 600/100 mg 2/day on Days 1-23 + morning dose
      on Day 24 + telaprevir 750 mg each 8 hrs on Days 11-20, and 1125 mg each 12hrs on Days 21 to
      23 + morning dose on Day 24. Group D: fAPV/rtv 700/100 mg 2/day on Days 1-23 + morning dose
      on Day 24, + telaprevir 750 mg each 8hrs Days 11-20, and 1125 mg each 12hrs on Days 21-23 +
      morning dose on Day 24.
    

Intervention name(s): Telaprevir; Darunavir; Ritonavir; Fosamprenavir
Intervention type(s): Drug
Intervention MeSH terms: Ritonavir; Darunavir; Fosamprenavir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: VX-950-TiDP24-C124; VX-950-C124; HCV; DDI; telaprevir; darunavir; ritonavir; fosamprenavir; interaction; pharmacokinetics; steady-state