Study to Examine Multiple Doses of TMC647055 in Combination With Telaprevir
Condition: Hepatitis C
MeSH terms: Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess safety, tolerability, pharmacokinetics (how the drug
      is absorbed into the bloodstream) and antiviral activity of repeated doses of TMC647055 given
      in combination with telaprevir in HCV infected patients. TMC647055 is being investigated for
      the treatment of hepatitis C infection. Telaprevir has recently been approved in the USA and
      in Europe for the treatment of chronic hepatitis C infected patients.
    

Detailed description: 
      This is a phase I, open label trial in genotype 1 hepatitis C virus (HCV) infected patients.
      The study population consists of 16 adult patients. TMC647055 is given as an oral solution
      and telaprevir (TVR) is given as oral tablets. Patients found to be eligible after the
      screening visit will be divided over 2 panels that will be performed sequentially. In the
      first panel, 8 patients will receive TMC647055 at a dose of 500 mg twice a day in combination
      with TVR at a dose of 1125 mg twice a day for 10 consecutive days. In the second panel, 8
      subjects will receive TMC647055 in combination with TVR for 14 days. TMC647055 and TVR dose
      will be decided based on results from panel 1. TMC647055 dose will not be higher than 1000 mg
      twice a day and TVR dose will be 1125 mg twice a day or 1500 mg twice a day. It could also be
      decided to change duration of panel 2 to 10 days. In that case, the timing of assessments of
      panel 1 will be followed. For the duration of dosing in the 2 panels, patients will remain on
      site. Immediately after the last dose in panels 1 and 2, patients will start the extension
      phase. In this phase, patients will receive TVR at a dose of 750 mg every 8 hours for 12
      weeks in combination with pegylated interferon alfa (Peg IFN)(180ug subcutaneous once weekly)
      and ribavirin (RBV) (1000 or 1200 mg per day orally depending on weight in 2 divided doses).
      After that they will receive either 12 or 36 weeks of PegIFN -RBV treatment at the same dose
      regimen, depending on virus levels at week 4 and 12 in this extension phase. In the extension
      phase, patients will come to the site for visits at week 2, 4, 8, 12, 16, 24, 36 (if
      applicable) and 48 (if applicable). Patients who prematurely drop out in panel 1 or 2, will
      have a follow-up visit at 2 and 4 weeks after their last dose. Patients participating in the
      extension phase will have a follow-up visit at 4 and 12 weeks after their last dose. Safety
      and tolerability will be evaluated throughout the study.
    

Intervention name(s): TMC647055; TMC647055; TVR; TVR; TVR; PegFN; RBV
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): type=exact number, unit=mg, number=500, form=solution, route=oral use. Panel 1: TMC647055 is to be taken twice daily at a dose of 500 mg per day for 10 days.; type=exact number, unit= mg, number=up to macimum 1000, form=solution, route=oral use. Panel 2: TMC647055 is to be taken twice daily at a maximum dose of 1000 mg for 10 or 14 days.; type=exact number, unit= mg, number=1125, form=tablet, route=oral use. TVR is to be taken twice daily at a dose of 1125 mg for 10 days.; type=exact number, unit=mg, number=1125 or 1500, form=tablet, route=oral use. In panel 2: TVR is to be taken twice daily at a dose of 1125 or 1500 mg for 10 or 14 days. In panel 3: TVR is to be taken twice daily at a dose of 1125 or 1500 mg for 6 days with on day 6 a morning dose only.; type= exact number, unit= mg, number=750, form=tablet, route=oral use. TVR is to be taken every 8 hours at a dose of 750 mg for 12 weeks.; type= exact number, unit= mcg, number=180, form=solution, route=subcutaneous. PegIFN is to be injected once per week for 24 or 48 weeks.; type=exact number, unit=mg, number=1000 or 1200, form=tablet, route=oral use. RBV is to be taken at 1000 or 1200 mg per day in 2 divided doses, depending on the weight for 24 or 48 weeks.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis C; TMC647055HPC1005; TMC647055; telaprevir