VX-950-TiDP24-C133 - A Phase I Study Investigating the Interaction Between Telaprevir and Escitalopram
Condition: Hepatitis C
MeSH terms: Hepatitis C
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the effect of steady-state telaprevir (TVR) 750
      mg q8h (3 times a day, every 8 hours) on the steady-state pharmacokinetics of escitalopram 10
      mg q.d. (once a day), and vice versa. Steady state is a term which means that the drug has
      been given long enough so that the plasma concentrations will remain the same with each
      subsequent dose. TVR is being investigated for the treatment of chronic hepatitis C virus
      (HCV) infection. Pharmacokinetics (pk) means how the drug is absorbed into the bloodstream,
      distributed in the body and eliminated from the body.
    

Detailed description: 
      Telaprevir is being investigated for treatment of chronic HCV infection, in combination with
      Peg-IFN (pegylated interferon) and RBV (ribavirin). Peg-IFN plus RBV are currently an
      accepted methode for treating HCV. Treatment with Peg-IFN plus RBV for HCV infection is
      associated with a high rate of depression. The results of this study will provide dosing
      recommendations for coadministration of Telaprevir (TVR) and escitalopram in HCV-infected
      patients. This is a Phase I, open-label (both participant and investigator know the name of
      the medication), randomized (study medication assigned by chance), crossover trial in 16
      healthy participants to investigate the pharmacokinetic interaction between escitalopram and
      TVR, both at steady state. Steady state is a term which means that the drug has been given
      long enough so that the plasma concentrations will remain the same with each subsequent dose.
      The participants will receive two treatments (treatment A-B or treatment B-A) in a randomized
      order. In Treatment A, participants will receive escitalopram 10 mg once daily (q.d.) for 7
      days. In Treatment B, participants will receive TVR 750 mg every 8 hours (q8h) for 14 days,
      with coadministration of escitalopram 10 mg q.d. from Day 8 to Day 14. There will be a
      washout period (a period where no treatment will be taken in view of having all the
      medication eliminated from the body before starting a new treatment) of at least 14 days
      between last intake of study medication in one session and first intake of study medication
      in the subsequent session. All study medication will be taken with food. Escitalopram will be
      taken once daily in the morning. During coadministration of TVR and escitalopram, the first
      dose of TVR should be taken together with escitalopram in the morning. Pharmacokinetic
      profiles of the two compounds will be measured through blood samples taken at regular
      intervals during the study and safety and tolerability will be assessed during the study
      period and in follow-up. Safety and tolerability evaluations will be recorded at regular
      intervals throughout the trial period. Blood and urine samples, electrocardiogram (ECG) and
      vital signs (blood pressure and hart rate) will be taken at screening, before medication
      intake on days 1 and 7 in each session and on day 14 in treatment B and at the 2 follow up
      visits at 5-7 and 30-32 days after last dose of drug in the last session. A physical
      examination will be performed at screening, on day before first medication intake in each
      session and during the 2 follow up visits. Participants in Treatment A will receive oral
      escitalopram 10 mg once daily for 7 days and in Treatment B participants will receive TVR 750
      mg q8h from Day 1 to Day 14, with coadministration of escitalopram 10 mg q.d. from Day 8 to
      Day 14.
    

Intervention name(s): Telaprevir; Escitalopram
Intervention type(s): Drug
Intervention MeSH terms: Escitalopram
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: VX-950-TiDP24-C133; VX-950-C133; VX950; HCV; telaprevir; escitalopram