Study to evaluate the PK Profile of PRN1008 MR formulations(QCL117643)

• Research type

  Research Study

• Full title

  A Study in Healthy Male and Female Subjects Designed to Evaluate the Pharmacokinetic Profile of Single Doses of PRN1008 Following Administration of Modified Release Prototype Formulations, to Evaluate the Pharmacokinetic Profile of PRN1008 in the Fed State (Optional) and Relative Bioavailability of a Selected Modified Release Prototype Formulation with the Immediate Release Formulation

• IRAS ID

  195938

• Contact name

  Robert Quesenberry

• Sponsor organisation

  Principia Biopharma Inc. and Principia Biopharma Australia Party Ltd.

• Eudract number

  2015-005262-36

• Duration of Study in the UK

  0 years, 3 months, 21 days

• Research summary

  The Sponsor is developing the study drug, PRN1008, for the treatment of autoimmune and inflammatory diseases. An autoimmune disease is when a patient’s immune system attacks healthy cells in their body by mistake. Symptoms of inflammation can include pain, heat and swelling. Arthritis is an example of inflammatory disease, which involves significant joint damage and pain. \n\nThe purpose of the study is to determine how well different formulations (recipes) of the study drug are taken up and processed by the body. The aim is to produce a tablet that can be given once per day and in a lower dose than the current tablet in use in clinical trials. To do this recipes will be developed that modify the time over which the study drug is released into the gut. The safety and tolerability of the study drug will also be assessed. \n\nThe study is split into two parts. Part 1 is an open-label, non-randomised, 6 period study in 16 healthy subjects, with the last 2 periods being optional. In Part 1, study subjects will receive a single dose of the study drug on up to 6 separate occasions. The drug may be given after an overnight fast or after breakfast. The results from this part of the study will allow a formulation to be selected for use in Part 2.\nPart 2 is an open label, randomised two-period complete crossover study in 12 healthy subjects. Subjects will receive a single dose of the study drug on two separate occasions after an overnight fast. On one occasion they will receive the tablet recipe used on previous clinical trials. On the other occasion they will receive the best recipe used in Part 1. The order in which the treatments will be received in Part 2 will be allocated at random.

• REC name

  East of England - Cambridgeshire and Hertfordshire Research Ethics Committee

• REC reference

  16/EE/0214

• Date of REC Opinion

  5 Jul 2016

• REC opinion

  Further Information Favourable Opinion