Relative bioavailability of TMC435 in healthy adult subjects

• Research type

  Research Study

• Full title

  A Phase I, open-label, randomized, 3-panel, 3-way crossover trial in healthy adult subjects to assess the relative bioavailability of TMC435 following administration of 2 liquid formulations or 2 different capsule concept formulations compared to the Phase III 150 mg capsule, and to assess the effect of food on the bioavailability of TMC435 following administration of the liquid formulations.

• IRAS ID

  95723

• Contact name

  Muna Albayaty

• Sponsor organisation

  Tibotec BVBA

• Eudract number

  2011-005808-14

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  The new medicine tested in this study is a compound called TMC435. This compound is being developed for treating chronic hepatitis C infection. The main purpose of the study is to see how the study drug is taken up, metabolised (chemically broken down), distributed through the body and excreted. A further aim is to look at how this process is possibly altered by food by giving the study drug in the presence and absence of meals. The study will also investigate how safe the study drug is, how well it is tolerated after dosing, and the acceptability of taste. Participants will receive the study medication in the form of a capsule or liquid formulation which they will swallow with a glass (240 mL) of water either after an overnight fast or after they have eaten a (high fat) breakfast. Approximately 72 participants will be included in the study. Participants will undergo the following procedures during the study: medical history and demographic data will be collected, physical examinations and electrocardiograms (ECGs) will be performed, height and weight will be measured, blood pressure, pulse rate and body temperature measurements will be taken, alcohol breath test will be performed, different kinds of urine and blood safety tests and urine drug test will be performed, blood samples for measurement of the concentration of study drug, any adverse events that participants experience and other medication they take, will be recorded. The study will be performed at the PAREXEL International Early Phase Clinical Unit in the UK (Harrow).

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  12/SC/0071

• Date of REC Opinion

  6 Mar 2012

• REC opinion

  Further Information Favourable Opinion