DB Crossover Study on Effect of TMC435 on QTc in healthy subjects

• Research type

  Research Study

• Full title

  A double-blind, double-dummy, randomized, 4-period cross-over, placebo and active-controlled study to evaluate the effect of TMC435 on the QTc interval in healthy subjects.

• IRAS ID

  67669

• Contact name

  Muna Albayaty

• Sponsor organisation

  Tibotec Pharmaceuticals

• Eudract number

  2010-022711-19

• Research summary

  The study will evaluate the effect of TMC435 on the electrocardiogram QTc interval (recording of the electrical activity of the heart muscle)in healthy subjects. TMC435 is a protease inhibitor (PI) in development for the treatment of chronic hepatitis C virus (HCV) infection. There is a need for new compounds that overcome the disadvantages of current HCV therapy. In recent clinical studies, new investigational products acting directly on the virally encoded protease target (an enzyme) have demonstrated that significant reductions in HCV ribonucleic acid (RNA)levels and improved sustained virologic response rates can be achieved when administered in combination with peginterferon-alpha and ribavirin. The HCV-encoded NS3/4A protease is essential for viral replication, and multidisciplinary discovery research has led to a new class of specific and potent NS3/4A protease inhibitors,including TMC435. This is a double blind, double-dummy, randomized, 4-period cross-over, placebo- and active- controlled Phase I study. Each subject will follow 4 sessions: 150 mg TMC435 once daily for 7 days (Treatment A), 350 mg TMC435 once daily for 7 days (Treatment B), a single dose of 400 mg moxifloxacin on Day 7 (Treatment C) and TMC435 placebo for 7 days(Treatment D). In each treatment dummy capsules will be added in order to have the same number of capsules in each treatment. The subjects will be randomly assigned to 1 of 4 treatment sequence groups and will receive the 4 treatments in the order specified by the randomization schedulre. There will be a washout period of at least 10 days between subsequent treatments.

• REC name

  East of England - Cambridgeshire and Hertfordshire Research Ethics Committee

• REC reference

  10/IEC06/8

• Date of REC Opinion

  21 Mar 2011

• REC opinion

  Further Information Favourable Opinion