A 2 way crossover study comparing Infacort® against Cortef® in adults
Research type
Research Study
Full title
A single centre, open-label, randomised, single dose, two-period, crossover, relative bioavailability study of Infacort® versus Cortef® immediate release hydrocortisone tablets in dexamethasone-suppressed healthy adult male subjects
IRAS ID
228297
Contact name
Annelize Koch
Contact email
Sponsor organisation
Diurnal Ltd
Eudract number
2016-001389-26
Duration of Study in the UK
0 years, 6 months, 12 days
Research summary
Infacort® is a novel, age appropriate, immediate release formulation of a drug called hydrocortisone designed to help people suffering from a condition called adrenal insufficiency, specifically children up to the age of 16.\n\nIn the present study Infacort® will be administered directly on the back of the subject’s tongue as dry granules in both the fed and fasted state.\n\nInfacort® will be compared against Cortef®, which is marketed formulation of hydrocortisone that has been available since 1952.\nThe study will be carried out in 48 subjects in total (healthy males and females), who have been given dexamethasone, a drug which is able to suppress the levels of natural cortisol (a hormone associated with the control of several different systems in the body such as blood sugar, metabolism etc) in the body. The study will be split into 2 parts; Part 1 will consist of dosing 24 subjects with Infacort® and Cortef® (1 drug per treatment period) in the fasted state. Part 2 of the study will consist of dosing 24 subjects with Infacort® and Cortef® (1 drug per treatment period) in the fed state (following consumption of a standardised high fat breakfast).\n\nInfacort® is intended as a replacement therapy for cortisol, so in order to assess the performance of the drug, cortisol levels will be measured. This will allow us to compare the effects against Cortef®. It is expected that Infacort® will behave similarly to Cortef®.
REC name
Wales REC 1
REC reference
17/WA/0152
Date of REC Opinion
9 Jun 2017
REC opinion
Favourable Opinion