A Study of Drug-drug Interaction Between Ritonavir and TMC435350 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the drug-drug interaction between steady-state
      concentrations of CYP3A4 or ritonavir and TMC435350 after its first and the last dose of the
      multiple dosing regimen and to explore the short term safety and tolerability of multiple
      doses of 200 mg of TMC435350 administered alone and in combination with 100 mg of ritonavir.
    

Detailed description: 
      This trial is a Phase I, open label trial (meaning that both the research physician and study
      participants will know which medication is being administered during the trial) in 12 healthy
      volunteers (referred to as participants) to investigate the effect of ritonavir, a marketed
      product used in several HIV medications, on the plasma levels of TMC435350, a new
      investigational drug in process of development for the treatment of hepatitis-C virus (HCV)
      infections. TMC435350 is a protease inhibitor (PI), a class of drugs that selectively inhibit
      the replication of the virus thereby inhibiting the progression of HCV infection. Plasma
      levels of TMC435350 are circulating levels of TMC435350 in the blood that are important for
      the antiviral activity of TMC435350. Ritonavir has the ability to increase the circulating
      levels of other compounds administered on the same day as Ritonavir. The trial will consist
      of 2 sequential sessions (Session 1 and Session 2) and all participants enrolled in the study
      will enter each session. In Session 1, participants will take TMC435350 200mg orally (by
      mouth) once daily for 7 days. There will be a waiting period of at least 7 days to allow any
      drug left in the body after the last treatment in Session 1 to be eliminated before the start
      of Session 2 (referred to as a "washout period"). In Session 2, participants will take
      ritonavir 100 mg orally twice daily on Days 1 to 15 and TMC435350 200mg once daily on Days 6
      to 12. All study drugs in both treatment sessions will be taken under fed conditions (i. e.,
      participants will eat a standard breakfast within approximately 30 minutes before they take
      study drug). Full pharmacokinetic profiles of TMC435350 (to investigate how the drug moves
      through the body, including the absorption, distribution, metabolism and elimination of the
      drug) will be determined from blood samples obtained on Days 1 and 7 of Session 1 and on Days
      6 and 12 of Session 2. Safety and tolerability will be recorded continuously. The total
      duration of treatment in the study for each participant will be approximately 30 days
      (includes 7 days of treatment in Session 1, 16 days of treatment in Session 2, and a washout
      period of at least 7 days between treatment sessions).
    

Intervention name(s): TMC435350 200 mg; Ritonavir 100 mg
Intervention type(s): Drug; Drug
Intervention description(s): Each patient will receive 200 mg (2 capsules) once daily orally from Day 1 to Day 7 in Session 1 and from Day 6 to Day 12 in Session 2; Each patient will receive 100 mg (1 capsule) of ritonavir twice daily orally from Day 1 until Day 15 of Session 2
Intervention MeSH terms: Ritonavir; Simeprevir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy; Hepatitis C; TMC435350; Ritonavir; Pharmacokinetics