A Study to Assess Bioavailability & Food Effect of Different Liquid and Capsule Formulations of TMC435.
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the relative bioavailability and the short-term
      safety and tolerability of TMC435 following administration of 3 single oral doses of 150 mg,
      given as different formulations in healthy adult participants. In addition, this study is to
      assess for the acceptability of the taste of both liquid formulations.
    

Detailed description: 
      TMC435 is being investigated for the treatment of chronic hepatitis C infection. The current
      study is a Phase I, open-label (both participant and investigator know the name of the
      medication given at certain moment), randomized (study medication is assigned by chance)
      study designed to assess the relative bioavailability and food effect of 2 liquid
      formulations of TMC435, currently being developed for potential pediatric use, compared to
      the Phase III 150 mg capsule. Also new capsule concept formulations will be investigated in
      comparison with the Phase III 150 mg capsule. The study will be performed in healthy adult
      participants and is divided over 3 panels. Participants will be randomized within a panel.
      Each participant will receive 3 different treatments according to a classical 6-sequence,
      3-period Williams design. In Panel 1 and Panel 2, a single oral dose of 150 mg TMC435 oral
      suspension respectively with other strength will be compared with the capsule used in Phase
      III. In Panel 3, two different capsule concept formulations will be compared with the capsule
      used in Phase III. In panels containing the liquids, formulations will be compared under
      fasted and fed conditions to investigate the food effect. In all treatments, the participants
      will receive medication on Day 1 of each treatment. There will be a washout period of at
      least 7 days between subsequent treatments. The main focus of the trial is the
      pharmacokinetic characteristics of all formulations (level-profile of TMC435 over time in the
      blood stream). This evaluation requires multiple blood samples from Day 1 till Day 4 in each
      treatment. Safety assessments (blood and urine tests, blood pressure, pulse,
      electrocardiogram, and physical examination) will follow a different schedule and will be
      evaluated from signing of the Informed Consent Form onwards until the last trial-related
      visit throughout the study.
    

Intervention name(s): TMC435 150 mg capsule; TMC435 150 mg oral suspension (20 mg/mL); TMC435 150 mg oral solution (10 mg/mL); TMC435 150 mg capsule concept K; TMC435 150 mg capsule concept L
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): single oral dose of 150 mg TMC435 150 mg capsule; single oral dose of 150 mg TMC435 oral suspension; single oral dose of 150 mg TMC435 oral solution; single oral dose of 150 mg TMC435 capsule concept K; single oral dose of 150 mg TMC435 capsule concept L
Other intervention name(s): TMC435; TMC435; TMC435; TMC435; TMC435
Intervention MeSH terms: Simeprevir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy volunteers; Food effect; Capsule; Formulations; Liquid formulation; Concept K; Concept L; Oral suspension; Oral solution; TMC435HPC1002; TMC435; HPC