VX-950-TiDP24-C136 - A Trial to Evaluate the Effect of Telaprevir (TVR) on the Results of Electrocardiograms (Electric Recording of the Heart) in Healthy Volunteers
Condition: Hepatitis C
MeSH terms: Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect of telaprevir on the results of
      electrocardiograms in healthy volunteers. An electrocardiogram is an electric recording of
      the heart. Telaprevir is being investigated for the treatment of chronic hepatitis C virus
      infection.
    

Detailed description: 
      This is a Phase I, double-blind, double-dummy, randomized, placebo- and active-controlled,
      4-period crossover trial. This means the study doctor nor yourself know in which treatment
      session you will receive which active medication or matching placebo. Every participant will
      receive each treatment in turn. The order in which you receive the treatment sessions is
      determined by chance, like tossing a coin. The purpose of the study is to evaluate the effect
      of telaprevir (TVR) on the results of electrocardiograms (electric recording of the heart).
      Two dose regimens of TVR will be tested, i.e. 750 mg every 8 hours (the dose that will be
      given to patients) and 1875 mg every 8 hours (a dose higher than the one that will be given
      to patients), administered for 4 days, with an additional morning dose on Day 5. A single
      dose of 400 mg moxifloxacin will be used as a positive control to assess trial sensitivity.
      The trial population will consist of 44 healthy volunteers. Treatment A will consist of TVR
      750 mg every 8 hours on Days 1-4 + single 750 mg morning dose on Day 5 (2 active TVR tablets
      + 3 TVR placebo tablets every 8 hours on Days 1 to 4 with a single morning dose on Day 5, and
      a single morning dose of moxifloxacin placebo on Day 5). Treatment B will consist of TVR 1875
      mg every 8 hours on Days 1 to 4 + single 1875 mg morning dose on Day 5 (5 active TVR tablets
      every 8 hours on Days 1 to 4 with a single morning dose on Day 5, and a single morning dose
      of moxifloxacin placebo on Day 5). Treatment C will consist of a single dose of 400 mg
      moxifloxacin (5 TVR placebo tablets every 8 hours on Days 1 to 4 with a single morning dose
      on Day 5, and a single morning dose of active moxifloxacin on Day 5). Treatment D will
      consist of placebo (5 TVR placebo tablets every 8 hours on Days 1 to 4 with a single morning
      dose on Day 5, and a single morning dose of moxifloxacin placebo on Day 5).There will be a
      washout period of 8 days between subsequent treatment sessions. Electrocardiograms (ECGs)
      will be recorded continuously for 24 hours by Holter monitoring (small electrodes will be
      attached to your chest and connected to a small device to record your heart rhythm over a
      24-hour period) on the day before intake of study medication starts and on Day 5 of all
      treatment sessions. In addition, for safety monitoring, separate ECGs will be performed at
      predefined time points. Samples to access pharmacokinetics (how the drug is absorbed into the
      bloodstream, distributed in the body and eliminated from the body) of TVR and moxifloxacin
      will be collected on the day before intake of medication starts and day 5 of all treatment
      sessions, as well as predose on Days 2, 3 and 4 of all treatment sessions. Safety and
      tolerability will be evaluated throughout the trial by evaluating results of blood- and urine
      analysis, vital signs, physical examinations, alcohol breath tests and by assessing how you
      are feeling. In every treatment session, participants will receive 5 oral tablets of 375 mg
      TVR or placebo every 8 hours on Days 1 to 4 with a single morning dose on Day 5, and a single
      oral morning dose of 400 mg moxifloxacin or placebo on Day 5. In between treatment sessions,
      there will be a wash-out period of 8 days.
    

Intervention name(s): Telaprevir; Moxifloxacin; Placebo
Intervention type(s): Drug
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: VX-950-TiDP24-C136; VX-950-C136; VX-950; HEPATITIS; Telaprevir; Moxifloxacin; ECG; QT; QTc