An investigation of 3 formulations of Chronocort®

• Research type

  Research Study

• Full title

  A two-part open label, randomised, single dose, crossover study in healthy volunteers to: (Part A) compare the pharmacokinetics of 3 Chronocort® formulations, and (Part B) determine the dose proportionality of a selected Chronocort® formulation at three dose levels with an additional comparison with the selected formulation dosed on two occasions over a 24 hour period

• IRAS ID

  71254

• Contact name

  Pui Man Leung

• Sponsor organisation

  Diurnal Ltd

• Eudract number

  2010-024398-37

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  The drug being tested in this study is Chronocort© (Hydrocortisone Modified Release capsules). It is being developed for the treatment of adrenal failure and is expected to better mimic the body's normal production of the hormone cortisol than current Hydrocortisone treatment. Hydrocortisone is a synthetic form of the hormone cortisol and its use is well-established for the management of conditions resulting from adrenal failure. This study comprises 2 parts. Part A is a study in 6 subjects to investigate the blood levels of Cortisol following administration of 30 mg of 3 different formulations of Chronocort©. These will be administered over 3 treatment periods. Following a review of the data from Part A, one of the formulations will be selected to be studied in Part B. Part B is a study in 16 subjects to investigate Cortisol blood levels following administration of different doses of the chosen formulation from Part A. The doses will be administered over 4 treatment periods and will be in the range of 5mg and 60mg. Chronocort© capsules will be administered as a single dose (in the range 5mg to 40mg) given at night on all occasions apart from one, where it will be given as a split dose to subjects participating in Part B (part of the total dose administered at night and the rest administered in the morning; the total dose will not exceed 60mg). Blood samples will be taken at specific timepoints throughout the study for cortisol concentrations. The drug Dexamethasone will also be administered to temporarily suppress natural cortisone levels and the associated hormone, ACTH. Safety assessments will be performed throughout the study and include: blood and urine samples taken for safety screens, measurement of Vital signs (blood pressure, pulse and body temperature) and 12-lead ECG. Adverse events will be monitored throughout.

• REC name

  Wales REC 1

• REC reference

  11/WSE04/1

• Date of REC Opinion

  4 Feb 2011

• REC opinion

  Further Information Favourable Opinion