Phase 1Completed
An Investigational Study of Hydrocortisone
An Open Label, Partially Randomised, Single Dose, Crossover Study to Evaluate the PK, Oral Bioavailability and Relationship to Metabolic Parameters of Hydrocortisone and Infacort® in Healthy Adult Male Volunteers.
- Sponsor
- Neurocrine UK Limited (Industry)
- Enrolment
- 14 enrolled
- Conditions
- Adrenal Insufficiency
- Interventions
- Hydrocortisone granules; Hydrocortisone Tablet; i.v. Hydrocortisone Injection; Dexamethasone
- Ages
- adults
- Registry
- NCT01960530
Full record on ClinicalTrials.gov
From the registry
This study will investigate a new drug called Infacort®; a newly-developed immediate release formulation of a well-established drug called hydrocortisone. Hydrocortisone is used as a replacement treatment for people whose adrenal glands are not producing enough natural cortisol - a condition known as adrenal insufficiency. The study will assess how Infacort® acts once inside the body, by measuring cortisol and other hormone levels in the body, compared to already marketed hydrocortisone tablet and hydrocortisone intravenous (through the vein) injection. The population who are eligible to take part in the study are healthy male volunteers, aged between 18 and 60 years of age.
Primary outcomes
- Maximum Serum Concentration (Cmax)
- AUC0-t
History
Last registry update
Results first posted
Primary completion
Started
Registered