A food effect study of Chronocort
Research type
Research Study
Full title
A single centre, open-label, randomised, single dose, three-period, crossover study to evaluate the bioavailability of a modified release hydrocortisone capsule (Chronocort®) under fasting and fed conditions and immediate release hydrocortisone tablets under fasting conditions, in dexamethasone-suppressed healthy adult male volunteers
IRAS ID
169228
Contact name
Robert Adams
Contact email
Sponsor organisation
Diurnal Limited
Eudract number
2014-005025-12
Duration of Study in the UK
0 years, 4 months, 6 days
Research summary
This study is an open-label, randomised, sequential, single dose, 3-period, crossover study in 18 healthy male volunteers between 18 and 60 years of age.
The study is to be conducted in healthy volunteers and therefore participants are not expected to derive any therapeutic benefit from taking part. In the future, it is expected that Chronocort® will improve the treatment of patients with congenital adrenal hyperplasia (CAH).
Volunteers will undergo 3 Study Periods, each separated by at least 7 days. Each Study Period will be approximately 1.5 days in duration.
Over the 3 study periods, the volunteers will receive the study medicines in a fed state and in a fasted state. Chronocort® is designed to provide a new form of corticosteroid hormone replacement therapy by releasing hydrocortisone in a manner that will enable doctors to achieve a daily cycle (circadian rhythm) of cortisol levels in patients that closely matches that of the normal population. This in turn should improve disease symptom control and may also increase the accuracy of the disease treatment and monitoring regimen, potentially reducing the incidence of over or under exposure to steroids.
The purpose of this study is to assess the impact of food on the pharmacokinetics of a modified release formulation of hydrocortisone (Chronocort®).
The data from this study will be used support treatment regimens in clinical practice. The duration of the study is approximately 6 weeks for each individual (from the Screening Visit to Post-Study Visit).
REC name
Wales REC 2
REC reference
14/WA/1251
Date of REC Opinion
18 Dec 2014
REC opinion
Further Information Favourable Opinion