An investigation of Chronocort® PK and dose proportionality.

• Research type

  Research Study

• Full title

  An open label, randomised, single dose, 3-period crossover study in healthy volunteers to: a) compare the pharmacokinetics of Chronocort® formulations versus immediate release hydrocortisone, and (b) determine the dose proportionality of Chronocort® formulations

• IRAS ID

  44274

• Contact name

  Salvatore Febbraro

• Sponsor organisation

  Diurnal Ltd

• Eudract number

  2009-017994-39

• 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 is to investigate the blood levels of Cortisol following Chronocort© administration at night and as a split dose administered at night and in the morning. These levels will be compared to those achieved following dose of immediate-release Hydrocortisone and with data of natural Cortisol levels from normal healthy individuals. In addition, this study will also examine different dose levels of Chronocort© and the corresponding levels of Cortisol achieved in the blood. The drug Dexamethasone will also be administered in order to temporarily suppress natural Cortisone levels and the associated hormone, ACTH. The sponsor, Diurnal Limited, will provide funding for this research. This is an open-label (both subjects and researchers will know which treatment is being received), 3-period crossover (each subject will receive all 3 treatments) study in a total of 30 healthy volunteers. There will be 3 Treatment Periods in total, each consisting of 1 over-night stay at Simbec and separated by a minimum of 7 days. The study will be conducted as 2 groups (Group 1 consists of 18 subjects and Group 2 consists of 12 subjects), each with a different purpose and treatment regimen. Blood samples will be collected for the measurement of Cortisol and ACTH levels, as well as for safety screens. Other safety parameters will also be measured at pre-determined time-points during the study; these include blood pressure, pulse and 12-lead ECG. Adverse events will be monitored throughout.

• REC name

  Wales REC 1

• REC reference

  10/WSE04/5

• Date of REC Opinion

  19 Feb 2010

• REC opinion

  Further Information Favourable Opinion