drugset / Trial / NCT01960530

An Investigational Study of Hydrocortisone

NCT01960530

Phase 1 Completed 14 enrolled Neurocrine UK Limited Simbec Research · collab
RandomizedCrossoverOpen-labelOther

Summary

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.

Timeline

Start
2013-10
Primary completion
2014-11
Completion
2014-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Hydrocortisone Other / unclassified 20 mg Oral