Diurnal, the physiological hormone replacement company, today announced that it has received Medicines and Healthcare products Regulatory Agency (MHRA) and Ethics Approval to carry out an open label, randomised, single dose crossover study in healthy volunteers of its lead product Chronocort®.
Chronocort® is a modified release hydrocortisone formulation for the treatment of Congenital Adrenal Hyperplasia and Adrenal Insufficiency both chronic, life-long disease. The outcomes of this Phase 1 study aim to compare the pharmacokinetics of Chronocort® to immediate release hydrocortisone and to determine the dose proportionality of Chronocort®.
The study will be carried out at Simbec Research located in Merthyr Tydfil (Wales, UK) and is expected to start during Q2, 2010.
Prof Richard Ross, Chief Scientific Officer, said:
"It is a tremendous credit to the Diurnal and Simbec teams to have completed and achieved regulatory submission in such a short space of time. We have begun enrolment in the study which we hope to start imminently".