A Crossover Study to Evaluate Relative Bioavailability of Simeprevir Age-appropriate Oral Formulation Candidates Compared With 150-milligram (mg) Oral Capsule in Healthy Adult Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the relative bioavailability (the extent to which a
      drug or other substance becomes available to the body) of simeprevir (SMV) following single
      dose administration of age-appropriate oral formulation candidates compared to the 150
      milligram (mg) capsule, and to assess the effect of food on the bioavailability of SMV
      following single dose administration of a selected age-appropriate oral formulation
      candidate.
    

Detailed description: 
      This is a Phase 1, open-label (all people know the identity of the intervention), randomized
      (study medication assigned to participants by chance), 2-panel, 3-way crossover (participants
      will receive different interventions sequentially during the trial) study in healthy adult
      participants. Participants will be equally divided over 2 panels, and will not be randomized
      between panels. Participants will not be allowed to switch panels. The study consists of 3
      parts: Screening Phase (that is, 28 days before study commences on Day 1); Open-label
      Treatment (in subsequent 3-treatment periods in each Panel, each separated with washout
      period of 7 days); and Post-Treatment Phase (up to 7 days after last study drug intake). The
      duration of the study per participant will be at least 19 days, screening and follow-up not
      included. All the eligible participants will be randomly assigned to 1 of the 6 treatment
      sequences in each Panel. In fasted conditions, study drug will be administered following a
      10-hour overnight fast. In fed conditions, participants will also fast from food for 10
      hours, but will consume a high fat/high calorie breakfast within a 30-minute period. Study
      drug will be administered 30 minutes after the start of breakfast. Participants will not be
      allowed to have food until at least 4 hours after study drug administration. Blood samples
      will be collected for evaluation of pharmacokinetics at pre-dose and post-dose of study
      treatment. Relative bioavailability of SMV formulations will be evaluated primarily.
      Participants' safety will be monitored throughout the study.
    

Intervention name(s): Treatment A; Treatment B; Treatment C; Treatment D; Treatment E; Treatment F
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 150 milligram (mg) SMV capsule with water under fed conditions.; Treatment B (3*50 mg capsules of SMV (including 50 mini-tablets of 1 mg each) with water under fed conditions.; Treatment C (3*50 mg dispersible SMV tablets dispersed in water under fed conditions).; *50 mg SMV capsules (including 50 mini-tablets of 1 mg each) with water or 3*50 mg dispersible SMV tablets dispersed in water under fed conditions.; 3*50 mg SMV capsules (including 50 mini-tablets of 1 mg each) with water or 3*50 mg dispersible SMV tablets dispersed in water under fasted conditions.; 3*50 mg SMV capsules (including 50 mini-tablets of 1 mg each) with yoghurt or 3*50 mg dispersible SMV tablets dispersed in apple juice under fed conditions.
Other intervention name(s): simeprevir; simeprevir; simeprevir; simeprevir; simeprevir; simeprevir
Intervention MeSH terms: Simeprevir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy; Simeprevir; Bioavailability