A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of TMC647055 in Combination With Ritonavir (Part 1) and the Co-administration of TMC435, TMC647055 and Ritonavir (Part 2) in Healthy Japanese Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to investigate the safety, tolerability, and pharmacokinetics of
      TMC647055 in combination with ritonavir (Part 1); potential pharmacokinetic drug-drug
      interactions between TMC435 and the combination of TMC647055 with ritonavir; and to evaluate
      the short-term safety and tolerability when TMC435, TMC647055 and Ritonavir are
      co-administered (Part 2) in healthy Japanese participants.
    

Detailed description: 
      This is a single-center study which consists of 2 parts, sequentially conducted in 2 separate
      panels of 24 healthy adult Japanese participants each. Part 1 is a double-blinded (neither
      physician nor participant knows the treatment that the participant receives),
      placebo-controlled (placebo is compared with the study medication to test whether the study
      medication has a real effect in clinical study), randomized (the study medication is assigned
      by chance) single ascending dose (SAD) part which will consist of a screening phase, a
      treatment phase, and a follow-up visit. Part 1 will have 3 cohorts (Cohort A, B, and C) with
      8 participants each and they will be randomly assigned to receive either a single oral dose
      of TMC647055 (6 participants) or placebo (2 participants) in combination with RTV. The study
      duration for each participant will be approximately 5 weeks from screening to follow-up visit
      as maximum in Part 1. Part 2 is an open-label, randomized, 3-way crossover part which will
      consist of a screening phase, 3 treatment phases, and a follow-up phase. Each of the 24
      participants will receive Treatment A, B, and C in 6 sequences (Treatment ABC, BCA, CAB, ACB,
      BAC, and CBA) with a washout period of at least 7 days between consecutive treatments. Safety
      evaluation will include assessment of adverse events, clinical laboratory tests, vital signs,
      electrocardiogram, and physical examination. The study duration for each participant will be
      approximately 10 weeks from screening to follow-up visit as maximum.
    

Intervention name(s): TMC647055; TMC435; Placebo; Ritonavir (RTV)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): TMC647055 150 mg (1 capsule), 450 mg (3 capsules), 600 mg (4 capsules) taken orally (by mouth) once daily on Day 1 in Part 1. TMC647055 450 mg (3 capsules), and 600 mg (4 capsules) taken orally once daily on Days 1 to 7 in Part 2; TMC435 1 capsule of 75 mg, 100 mg, and 150 mg taken orally on Days 1 to 7 in Part 2; Placebo capsule once daily taken orally on Day 1 in Part 1; RTV 30 mg (ie, 0.38 mL oral solution of RTV [80 mg/mL strength]) taken orally on Day 1 in Part 1 and on Days 1 to 7 in Part 2
Intervention MeSH terms: Ritonavir; Simeprevir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Healthy; TMC647055; TMC435; Simeprevir; Sovriad; Ritonavir (RTV)