Open-label Comparison of Chronocort® Versus Standard Glucocorticoid Replacement Therapy

Exclusion Criteria

• •Participants are excluded from the study if any of the following criteria apply (note: if a participant meets an exclusion criterion, re-screening is permitted if the Investigator considers that the circumstances leading to screening failure will not be relevant when the participant is re-screened at a later time):
• •Medical Conditions
• •1. Clinical or biochemical evidence of hepatic or renal disease e.g. creatinine \> 2 times the upper limit of normal (ULN) or elevated liver function tests (alanine aminotransferase \[ALT\] or aspartate aminotransferase \[AST\] \>2 times the ULN).
• •2. History of bilateral adrenalectomy.
• •3. History of malignancy (other than basal cell carcinoma successfully treated \>26 weeks prior to entry into the study).
• •4. Participants who have type 1 diabetes or any participant who is receiving insulin.
• •5. Participants with any other significant medical or psychiatric conditions that in the opinion of the Investigator would preclude participation in the study.
• •Prior/Concomitant Therapy
• •6. Participants on regular daily oral steroids for any indication other than CAH. Note: a participant should not be given any steroids (even on an irregular basis) within 5 days of a study visit. If there is a medical need for steroid treatment within this time frame then the visit should be postponed until a 5-day interval has elapsed.
• •7. Co-morbid condition requiring daily administration of a medication or consumption of any material that interferes with the metabolism of glucocorticoids (examples provided at http://medicine.iupui.edu/clinpharm/ddis/clinical-table/).
• •8. Participants who are receiving \<10 mg hydrocortisone dose at baseline or the hydrocortisone dose equivalent.
• •Prior/Concurrent Clinical Study Experience
• •9. Participation in another clinical study of an investigational or licensed drug or device within the 12 weeks prior to screening or during the study.
• •10. Inclusion in any natural history or translational research study that would require evaluation of androgen levels during the study period outside of this study protocol assessments.
• •11. Participants who have previously been exposed to Chronocort in studies DIUR-003, DIUR-005 or DIUR-006.
• •Other Exclusions
• •12. Participants who routinely work night shifts and so do not sleep during the usual night-time hours.
• •13. Participants unable to comply with the requirements of the protocol.