An Investigation of Infacort when given by 3 different methods
Research type
Research Study
Full title
A single centre, open-label, randomised, single dose, three-period, crossover study to evaluate the bioavailability of Infacort® administered as ‘sprinkles’ with soft food and yoghurt compared with direct administration to the back of the tongue in dexamethasone-suppressed healthy adult male subjects.
IRAS ID
204917
Contact name
Dena Digweed
Contact email
Sponsor organisation
Diurnal Ltd
Eudract number
2016-001388-36
Duration of Study in the UK
0 years, 6 months, 21 days
Research summary
Infacort® is a new, age appropriate, formulation of immediate release hydrocortisone that is designed to help people suffering from adrenal insufficiency, specifically children up to the age of 16.
In the present study Infacort® will be administered as sprinkles with yoghurt, soft food (e.g. apple sauce) and direct administration to the back of the tongue; during 3 treatment periods. The study will be carried out in 18 healthy males, who have been given dexamethasone to suppress naturally occurring cortisol in the body.
Infacort® is intended to increase levels of cortisol, so in order to assess the performance of the drug, cortisol levels will be measured. This will allow us to see if there is any variation depending on the method by which the Infacort® is administered.
REC name
Wales REC 1
REC reference
17/WA/0114
Date of REC Opinion
4 May 2017
REC opinion
Favourable Opinion