Safety tolerability PK of TMC435/647055 in healthy Japanese volunteers

• Research type

  Research Study

• Full title

  A Phase 1, double-blind, placebo-controlled, randomized, single ascending dose study to investigate the safety, tolerability, and pharmacokinetics of TMC647055 in combination with a pharmacokinetic enhancer (Part 1) followed by an open-label, randomized, 3-way crossover study to evaluate short-term safety, tolerability and pharmacokinetics of the coadministration of TMC435, TMC647055 and a pharmacokinetic enhancer, at steady-state (Part 2) in healthy Japanese subjects.

• IRAS ID

  144549

• Contact name

  Muna Albayaty

• Contact email

  muna.albayaty@parexel.com

• Sponsor organisation

  Janssen-Cilag NV/SA

• Eudract number

  2013-004236-30

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  14/LO/0211

• Date of REC Opinion

  18 Mar 2014

• REC opinion

  Further Information Favourable Opinion