PRIME

• Research type

  Research Study

• Full title

  A study of the pharmacokinetic and pharmacodynamic responses in healthy and altered human cardiovascular systems

• IRAS ID

  211984

• Contact name

  Joseph Cheriyan

• Contact email

  jc403@medschl.cam.ac.uk

• Sponsor organisation

  Cambridge University Hospitals NHS Foundation Trust and University of Cambridge

• Duration of Study in the UK

  3 years, 0 months, 1 days

• Research summary

  What is the research question?
  Safety is an integral part of developing new medicines. Potential drugs can be withdrawn from development at any stage of the process if there are concerns over safety. In recent years, computer models that recreate bodily processes have been increasingly adopted in drug development, including safety, to predict the effects of new drugs. However, the accuracy of this predictive model is dependent on the ability for animal data (which the model is usually based on) to be ‘translated’ to human data. As no animal is identical to humans, the difference between species needs to be understood for the model to work.

  What is being studied?
  Unwanted effects on the cardiovascular system is one of the most common causes of safety related discontinuation of a drug. The aim of this research project is to create a computer model of the human cardiovascular system that can address the issue of translation. To achieve this, we need human data that is comparable with existing animal data. The present study has been designed to allow collection of high quality data in humans after administration of drugs that are known to affect the cardiovascular system. By increasing our understanding of the differences, we will be able to improve the accuracy of the model to predict effects in humans from animal data.

  Who is eligible?
  There will be three parts to the study, each looking at different populations. Part A – healthy volunteers; Part B – participants with challenged cardiovascular systems; Part C – participants with autonomic dysfunction.

  Where will the study take place?
  The study will be conducted at Addenbrooke’s site

  How long will the studies last?
  There are 5 visits required for the study. 1x screening/consenting visit, 4x study visits. Each study visit will be up to 8 hours duration and a minimum 72 hours period in between each study visit.

• REC name

  Wales REC 4

• REC reference

  17/WA/0034

• Date of REC Opinion

  5 Feb 2017

• REC opinion

  Favourable Opinion