Bioavailability Study of Crushed vs Whole Ticagrelor Tabs

• Research type

  Research Study

• Full title

  An Open-label, Randomised, 3-Period, 3-Treatment, Crossover,Single-centre, Single-dose, Bioavailability Study with Alternative Methods of Administration of Crushed Ticagrelor Tablets, 90 mg, Compared to Whole Ticagrelor Tablets, 90 mg, in Healthy Volunteers

• IRAS ID

  130149

• Contact name

  Saeed Khan

• Contact email

  saeed.kahn@quintiles.com

• Sponsor organisation

  AstraZeneca R&D Mölndal

• Eudract number

  2013-001052-35

• Research summary

  Ticagrelor (BRILINTA™, BRILIQUE™) is a medicine which is prescribed in combination with aspirin for the treatment of a heart attack, orunstable angina (angina or chest pain that is not well controlled). It was approved in Europe and USA in 2010 & 2011, respectively.

  Ticagrelor belongs to a group of medicines called anti-platelet medicines such as Clopidogrel or Aspirin.

  Ticagrelor affects blood cells called ‘platelets’. These very small blood cells help stop bleeding by clumping together to plug tiny holes in blood vessels that are cut or damaged. However, platelets can also form clots inside diseased blood vessels in the heart and brain.

  This can be very dangerous because the clot can cut off the blood supply completely - this can cause a heart attack (myocardial infarction) or stroke, OR the clot can partly block the blood vessels to the heart - this reduces the blood flow to the heart and can cause chest pain which comes and goes (called ‘unstable angina’).

  Ticagrelor helps stop the clumping of platelets. This reduces the chance of a blood clot forming that can reduce blood flow and might result in heart attack or stroke.

  This study is conducted to compare the level of ticagrelor in blood at various times when administered (a) by swallowing the whole tablet with water, (b) by swallowing the crushed tablet dissolved in water, and (c) by giving the crushed tablet dissolved in water through a nasogastric tube (a tube inserted through the nose and into the stomach). The administration through nasogastric tube in this trial will help patients with heart attack who are in critical condition and have difficulties in swallowing the tablets.

  Up to 36 healthy volunteers aged 18-50 would participate in this study. The total volume of blood to be taken for the entire duration of the study will be no greater than 350 ml.

• REC name

  East of England - Cambridgeshire and Hertfordshire Research Ethics Committee

• REC reference

  13/EE/0132

• Date of REC Opinion

  21 May 2013

• REC opinion

  Favourable Opinion