TMC435-TiDP16-C112 - Interaction Trial With Antidepressants
Condition: Hepatitis C Virus
MeSH terms: Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the effect of steady-state concentrations of
      TMC435 150mg q.d. (once a day) on the steady-state pharmacokinetics of escitalopram 10 mg
      q.d., 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.
      TMC435 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: 
      TMC435 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 methods 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 TMC435 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 18 healthy
      participants to investigate the pharmacokinetic interaction between escitalopram and TMC435,
      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 three treatments (treatment A-B-C) in a randomized order. In
      Treatment A, participants will receive TMC435 150 mg q.d. In Treatment B, participants will
      receive escitalopram 10 mg q.d. In treatment C, participants will receive escitalopram 10 mg
      q.d. and TMC435 150 mg q.d. All treatments will be administered for 7 days and with food.
      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 10
      days between last intake of study medication in one session and first intake of study
      medication in the subsequent session. 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 heart
      rate) will be taken at screening, before medication intake on days 1 and 7 and on Day 8 in
      each session and at the 2 follow up visits at 1 week and 4-5 weeks after last dose of drug in
      the last session. A physical examination will be performed at screening, on day -1 (= day
      before day of first medication intake in each session) and during the 2 follow up visits. On
      the morning before first medication intake (in the first session only) a blood sample will be
      taken to examine your CYP2C19 genes, which are responsible for the production of enzymes that
      determine the breakdown of drugs in your body. The results of this study will provide dosing
      recommendations for coadministration of TMC435 and escitalopram in HCV-infected patients.
      Participants will receive in treatment A TMC435 150 mg q.d., in treatment B participants will
      receive escitalopram 10 mg and in treatment C participants will receive escitalopram 10 mg
      q.d. + TMC435 150 mg q.d. All treatments will be administered for 7 days and with food.
    

Intervention name(s): TMC435; Escitalopram; TMC435 + Escitalopram
Intervention type(s): Drug; Drug; Drug
Intervention description(s): TMC435 150 mg daily for 7 days; Escitalopram 10 mg daily for 7 days; TMC435 150 mg + escitalopram 10 mg daily for 7 days
Intervention MeSH terms: Simeprevir; Dexetimide; Citalopram; Escitalopram
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: TMC435-TiDP16-C112; TMC435-C112; TMC435; HCV; Hepatitis C